Section 3: Appendices

Appendix C: Noteworthy Grantee Accomplishments Selected by the Panel

Award: H133A020510 ID:23, 01-Oct-02 to 30-Sep-07
Grant Title: Rocky Mountain Regional Brain Injury System
Host Institution/Grantee Name: Craig Hospital
Principal Investigator: Whiteneck, Gale
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. As part of a TBI Model System Module Project, we were the lead center to develop a new measure of participation for individuals with TBI.  The Participation Assessment from Recombined Tools (PART).

Description of accomplishment and supporting evidence. The PART was designed to combine the best items from four existing participation measures to form a new and improved objective measure of participation. A pool of participation items was formed from questions contained in four participation instruments: 1) the Craig Handicap Assessment and Reporting Technique Short Form (CHART-SF), 2) the Community Integration Questionnaire Version 2 (CIQ-2), 3) the Participation Objective-Participation Subjective (PO-PS) section of the Living Life After TBI (LLATBI), and 4) the Mayo-Portland Participation Index (MP2I). The resulting 78-item PART was administered to 400 individuals from eight TBI Model Systems enrolled in the National TBI Model System Database, in conjunction with Form II data collection as they crossed their 1st, 2nd, 5th, 10th, and 15th anniversary of injury. Factor analysis was used to assess the dimensionality of PART items and Rasch analysis was used to identify a parsimonious set of items that best measured the concept of participation. Twenty-six items were selected which represented the breadth of the participation content and had good psychometric properties. In a Rasch analysis, these 26 items had a person reliability of .88, an item reliability of .99, an infit range between .78 and 1.18, and an item logit range between -2.4 and 1.8, indicating the 26 items contributed to a psychometrically strong measure with good internal reliability, all items contributing to a single construct, and items covering the full range of potential responses. Furthermore, the 26 PART items correlated strongly with other measures of participation and demonstrated expected correlations with other disability outcomes. This short form of PART, containing 26 objective items, has been recommended for further testing and potential implementation in the TBI Model Systems National Database in the next funding cycle.

Documentation. Results of this measurement development were presented as follows: Whiteneck G. Improving participation measurement in TBI Model Systems. A platform presentation at the 2nd Federal Interagency Conference on TBI, Bethesda, MD, March, 2006.

Citation. Whiteneck G. Improving participation measurement in traumatic brain injury model systems. The 2nd Federal Interagency Conference on Traumatic Brain Injury: Integrating Models of Research and Service Delivery, Bethesda, MD, March, 2006.
Web site: www.tbi-interagency.org/pdf/gwhiteneck.pdf [forbidden public access]

Problem addressed. All previous participation measures had psychometric weaknesses and no consensus existed among researchers about the best participation measure to use.

Award: H133N000019 ID:51 - 01-Dec-00 to 30-Nov-06
Grant Title: University of Pittsburgh Model System on Spinal Cord Injury
Host Institution/Grantee Name: University of Pittsburgh
Principal Investigator: Boninger, Michael
Program Mechanism: Model System
Funding per year: $320,000

Accomplishment. Pushrim Activated Power Assist Wheelchairs (PAPAW). In 2005 we continued to advance our research program investigating the effectiveness of pushrim activated power assist wheelchairs (PAPAW). This research program is directed at determining the effectiveness of PAPAW and improving mobility for individuals with spinal cord injury (SCI).
Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. Two separate facts indicate success of this research line. Our initial work in this area began with a prototype design in 1998. At that time there were no commercially available PAPAW on the market. In the past five years, three separate companies have marketed and sold PAPAW in the United States. In addition, we have sales figures that indicate increased sales for the companies. While it could be argued that the success of PAPAW is related to their innovation, without research results to support their value, it is likely less devices would have been sold. Our research findings directly led to approval of PAPAW in the Department of Veterans Affairs Health System, and the Centers for Medicare and Medicaid Services creating a code and reimbursement for the devices.

Documentation. The Department of Veterans Affairs prosthetics database 1) Albers sales figures 2) Yamaha sales figures The journal publications listed below are available through searchable medical literature databases.

Citation. 1) Algood SD et al Effect of a Pushrim Activated Power Assist Wheelchair on the Functional Capabilities of Persons with Tetraplegia, Arch Phys Med Rehabil, Vol 86(3) 380-6, 2005 2) Algood SD et al Impact of Pushrim-Activated Power-Assisted Wheelchair on the Metabolic Demands, Stroke Frequency, and Range of Motion Among Subjects with Tetraplegia, Arch Phys Med Rehabil, Vol 85 (11) 1865-71, 2004 3) Corfman TA et al Range of Motion and Stroke Frequency Differences Between Manual Wheelchair Propulsion and Pushrim Activated Power Assisted Wheelchair Propulsion, J Spinal Cord Med, Vol 26(2) Summer 2003 4) Fitzgerald SG et al A Pilot Study on Community Usage of a Pushrim Activated Power Assist Wheelchair, ASSIST TECHNOL , Vol 15.2, 113-9, Winter 2003 5) Cooper RA, et al Performance Assessment of a Pushrim Activated Power Assisted Wheelchair Control System, IEEE Control Systems, Vol 10(1) 121-6, 2002 6) Cooper RA et al Evaluation of a Pushrim Activated Power Assisted Wheelchair, Arch Phys Med Rehabil, Vol 82(1) 702-8, 2001 7) Arva J et al Mechanical Efficiency and User Power Requirement with a Pushrim Activated Power Assisted Wheelchair, Med Eng Phys, Vol 23(10) 699-705, 2001

Problem addressed. Over 50% of individuals with SCI who propel manual wheelchairs develop upper limb pain. The options for mobility for those with arm pain, used to be limited to either a power wheelchair, or continued pain during manual wheelchair use. In the last few years manufactures have started to produce PAPAW. PAPAW look and work similar to a manual wheelchair, but have a battery and motor to assist the user when propelling a wheelchair. PAPAW are reportedly easier to transport that standard power chairs and provide some exercise during use. Because of limited arm strength, PAPAW may also benefit individuals with tetraplegia. One problem faced by patients and clinicians is the need to justify the purchase of PAPAW in order to gain insurance coverage. Our model system has a research program to investigate the potential benefits of PAPAW for individuals with SCI. The number of PAPAW units sold doubled from 2003 to 2004 and continued to increase in 2005.

Award: H133N000019 ID:52 - 01-Dec-00 to 30-Nov-06
Grant Title: University of Pittsburgh Model System on Spinal Cord Injury
Host Institution/Grantee Name: University of Pittsburgh
Principal Investigator: Boninger, Michael
Program Mechanism: Model System
Funding per year: $320,000

Accomplishment. IBOT Development - VA Eligibility and Medicare Coding - the Department of Veterans Affairs approved the IBOT4000 for provision to eligible veterans as a prosthetic benefit. Medicare has held hearings and has a decision pending related to the coding and reimbursement for the advanced mobility devices to include the IBOT4000.

Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. The specific accomplishment is the publication of the VA eligibility notification and guidelines. The Medicare decision is pending, but the fact that the research findings are being used as part of the process is positive. The VA decision was announced in July 2005, and then implemented in January 2006. Implementation is currently taking place, and being followed by CMS. The VA program requires medical eligibility, and an assessment at an approved regional clinical site. The consumer must meet VA prosthetics service eligibility criteria, have a disability requiring the need for a wheelchair, and be able to use the IBOT safely and effectively. Medicare is reviewing the IBOT more as a prosthetic or orthotic device, because of the multiple functions available on the IBOT and the ability to activate and tune them for specific users. Currently a set of codes is being considered to account for the various functions available with the IBOT (balance, 4-wheel, standard, remote).

Documentation. http://www1.va.gov/opa/fact/pros-sensory.asp

Citation. (Work completed prior to 2005 is listed to show the entirety of activity. In addition, the work in press for 2006 was largely completed in 2005.) Cooper RA, Boninger ML, Cooper R, Kelleher A, Use of the Independence 3000 IBOTTM Transporter at Home and in the Community: A Case Report, Disability & Rehabilitation: Assistive Technology, Vol. 1, No. 1-2, pp. 111-117, 2006. Cooper RA, Boninger ML, Cooper R, Fitzgerald SG, Dobson A, Preliminary Assessment of a Prototype Advanced Mobility Device in the Work Environment of Veterans of Spinal Cord Injury, Neurorehabilitation, Vol. 19, No. 2, pp. 161-170, 2004.

Problem addressed. The specific target population is all individuals with SCI who rely on wheelchairs for mobility. Individuals with SCI have mobility limitations to restrict their ability to access many environments, including some workplaces and social environs (eg., visitation with friends in the their homes).

Basis for accomplishment. Many of the references used in the VA decision making process and in the CMS deliberation are from our Center. Our Center has published more peer-reviewed studies on the IBOT than any other group.

Award: H133N000019 ID: 53 - 01-Dec-00 to 30-Nov-06
Grant Title: University of Pittsburgh Model System on Spinal Cord Injury
Host Institution/Grantee Name: University of Pittsburgh
Principal Investigator: Boninger, Michael
Program Mechanism: Model System
Funding per year: $320,000

Accomplishment. The GAMECycle Exercise system, a novel upper extremity exercise system that combines arm ergometry with videogame play, has been developed for wheelchair users to provide them with access to motivational and challenging alternatives to common exercise routines. The GAMECycle has been improved from the alpha prototype to a commercial product that is currently available on the market, and research is being conducted to evaluate its effectiveness as a means of exercise.
Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. Three phases of GAMECycle Upper Extremity Exercise System development were accomplished in the past year. A focus group of 8 clinicians, 8 wheelchair users, and 2 clinician/wheelchair users was conducted and from the focus group results an improved prototype, the beta prototype, was designed to further meet the needs of the target population (1,3). Using the beta prototype Training Phase testing was conducted with 14 subjects who use wheelchairs as their primary means of transportation. This phase of testing has shown that the new version of the GAMECycle is easy to learn and use, that subjects report a higher satisfaction with the design, and that subjects can reach their target exercise zones (2). The current phase, the In-Home phase, is comparing the GAMECycle to regular arm ergometry, over 4 months of in-home use. 13 subjects will be recruited for this phase, and currently 9 subjects have been enrolled.

Documentation. Publications listed below www.3rivers.com/gamecycle.php

Citation. Work completed prior to 2005 is listed to show the entirety of activity. In addition, the work in press for 2006 was largely completed in 2005. Fitzgerald SG, Cooper RA, Zipfel E, Spaeth DM, Puhlman JR, Kelleher A, Cooper R, Guo S, The Development and Preliminary Evaluation of a Training Device for Wheelchair Users: The GAMEWheels System, Disability and Rehabilitation: Assistive Technology, pp. 129-139, Vol. 1, No. 1-2, January-June 2006. Guo S, Grindle GG, Authier EL, Cooper RA, Fitzgerald SG, Kelleher AR, Cooper R, Development and Qualitative Assessment of the GAMECycle Exercise System, IEEE Transactions on Neural Systems and Rehabilitation Engineering, pp. 83-90, Vol. 14, No. 1, March 2006. Fitzgerald SG, Cooper RA, Thorman T, Cooper R, Guo S, Boninger ML, The GAMECycle Exercise System: A Comparison to Standard Ergometry, Journal of Spinal Cord Medicine, Vol. 27, No. 5, pp. 453-459, 2004.

Problem addressed. Wheelchair users benefit from exercise through reduced risk of cardiovascular disease, better functioning in the activities of daily living, increased self-esteem, and improved rehabilitation outcomes. Unfortunately, wheelchair users report that the exercise options they have provide little motivation to exercise. Thus, there is a need to create environments in which people in wheelchairs are able and motivated to exercise. The GAMECycle addresses this need by merging exercise with videogame playing. In earlier phases of this research, lab testing demonstrated that an alpha prototype of the GAMECycle allowed users to maintain target aerobic training levels, and was perceived by users as fun and as likely to enhance their motivation to exercise more frequently.

Basis for accomplishment. There has been successful completion of research studies that show that the GAMECycle is an effective exercise device. The technology has been transferred to a small business (Three Rivers Holding, Inc) whose primary focus is selling assistive technology to individuals who use wheelchairs. In the past year, 75 GAMECycle Exercise systems have been sold across the country to rehabilitation clinics (such as Walter Reed Army Medical Center) as well as to individuals.

Award: H133A020513 ID:67, 01-Oct-02 to 30-Sep-07
Grant Title: Spaulding/Partners Traumatic Brain Injury Model System at Harvard Medical School
Host Institution/Grantee Name: Spaulding Rehabilitation Hospital
Principal Investigator: Glenn, Mel
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. An article on the test-retest reliability of the Virtual Planning Test was published. The study was done in response to a comment by the peer reviewers of our application that we should find a functional outcome measure that assesses executive function for our fMRI study. The Virtual Planning Test was the best such measure that we could find. However test-retest reliability had not been established, so we undertook to study this before using the test since it would have to be done twice on each subject if it were to be used in our study. 1a) The target populations were researchers/clinicians.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. This study shows that the Virtual Planning Test has poor test-retest reliability. Supporting evidence is the appearance of the article in the journal Brain Injury in December 2005.

Documentation. O'Neil-Pirozzi TM, Goldstein R. Test-re-test reliability of the virtual planning test. Brain Injury December 2005; 19(14):1191-1196

Citation. O'Neil-Pirozzi TM, Goldstein R. Test-re-test reliability of the virtual planning test. Brain Injury December 2005; 19(14):1191-1196

Problem addressed. Neuropsychological testing assists clinicians and researchers with the assessment of various cognitive functions in people with TBI. However it is limited by its lack of connection to real world activities. There is no ecologically valid measure of executive function in people with TBI that has adequate psychometric properties. Such a measure is needed for research on executive function in the target population and for clinical assessment. The Virtual Planning Test was the best such measure that we could find, but test-retest reliability had not been established.

Basis for accomplishment. Research Study: The test-retest reliability of the Virtual Planning Test.

Award: H133B040034 ID: 99, 01-Oct-04 to 30-Sep-09
Grant Title: RRTC on Health & Wellness in Long Term Disability
Host Institution/Grantee Name: Oregon Health & Science University
Principal Investigator: Krahn, Gloria
Program Mechanism: Rehabilitation Research and Training Center
Funding per year: $700,000

Accomplishment. The findings from the Self-Definition of Health Practices, Opportunities and Barriers Project and the Health Constructs and Measurement Project (from previous RRTC funding cycle) have contributed to the development of a new concept of health and wellness for people living with disabilities. The idea that persons with disabilities (of all ages) can be both healthy and well conceptually differentiates "health" from "disability." The first round of the RRTC focused on creating awareness that people with disabilities are capable of living healthy lives. The RRTC aims to support the development of a national agenda on health and wellness of persons with long-term disabilities and participation in national and international organizations to fulfill that agenda. Targeted publications, presentations and technical assistance have contributed to a changing awareness by many, including the US Surgeon General's report, that persons living with disabilities can participate fully in their communities and can lead long, happy and productive lives with some accommodations for their impairments.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. Evidence that the findings contained in the nominated nugget are creating awareness and advancing knowledge is reflected by citations by other researchers and policy makers.
1) Based on preliminary work on distinguishing health from disability and developing health promotion initiatives, Gloria Krahn, PhD, MPH (RRTC: Health and Wellness PI) was invited to present at the Surgeon General's conference on health disparities for people with intellectual disabilities in December, 2001. The conference report, Closing the Gap: A National Blueprint to Improve the Health of Persons with Mental Retardation (2002), has been cited in 44 journal articles between 2005-2006 and continues to be available online.
2) In the first cycle of the Wellness RRTC, we advanced this concept through a focus group study in which people with disabilities self-defined disabilities. Through qualitative methodology the narrative responses were thematically coded and were published in 2003 (Putnam, Powers, 2003). This paper was cited in three journal articles in 2005-2006 and a research brief of the study was specifically referenced in the state of California's 2005-10 Strategic Plan for Promoting the Health of People with Disabilities. See citations below.
3) In the Science Conference for the Wellness RRTC, Gloria Krahn presented the keynote address on Changing Concepts of Health and Disability in which she further described this conceptual distinction and provided examples of its implications. The conference was attended by more than 125 researchers, policymakers and advocates, with proceedings distributed to more than 500 people and available online. This work was cited three times in the 2005 Surgeon General's report Call to Action to Improve the Health and Wellness of Persons with Disabilities. (US Department of Health and Human Services, Office of the Surgeon General, 2005.). The Surgeon General's 2005 Report has subsequently been used by the state of Montana in its Strategic Plan, and by the New York State Comprehensive Plan for Mental Health Services, changing policy regarding people with disabilities in those states. It has been cited and used by the state of Maine Disabilities Advocates Council, the Virginia Board for People with Disabilities for their Biennial Report, the Montana Disability & Health program, New York State's strategic plan and the National Spinal Cord Injury Association among others. These organizations are instrumental in influencing policy in their respective states. It has also been cited in several journal articles and is on many websites for advocacy for persons with disabilities.
4) Dr. Krahn has been invited to serve as a speaker, writer and site reviewer on this topic of health and disability. She has been invited to provide the keynote address at one national and two international conferences, has been requested to write two papers for the Mental Retardation Research Review, and has been requested as a site reviewer to provide technical assistance on health promotion and disability at four University Centers of Excellence in Developmental Disabilities: Westchester, New York, 2003; New Jersey, 2004; New Mexico, 2004; Vermont, 2006 and will provide a similar service in July 2006 to the program in Montana. See citations below.

Documentation. Our work in disentangling health from function for people with disabilities is described or cited in:  USDHHS. The Surgeon General's Call To Action To Improve the Health and Wellness of Persons with Disabilities. US Department of Health and Human Services, Office of the Surgeon General, 2005.  Putnam M, Geenen S, et al. Health and wellness: people with disabilities discuss barriers and facilitators to well being. J Rehabil. 2003;69(1):37-45. Putnam article cited in: Harrison, T. Health Promotion for Persons With Disabilities: What Does the Literature Reveal? Fam Commun Health. 29(1) Supplement:12S-19S, 2006. Scelza, W M, Kalpakjian, C Z, et al. ABPP Perceived Barriers to Exercise in People with Spinal Cord Injury. Am J Phys Med Rehabil. 84(8):576-583, 2005. Pelletier, J.R., Nguyen, M. et.al. A study of a structured exercise program with members of an ICCD certified clubhouse: Program design, benefits, and implications for feasibility. Psych Rehabil J. 29 (2): 89-96, 2005. Universal Livability: A Dream for Tomorrow, A Plan for Today, California 2005-10 Strategic Plan for Promoting the Health of People with Disabilities. Office on Disability and Health and Living Healthy Advisory Committee, California Department of Health Services, March 2005. www.dhs.ca.gov/epic/odh/plan      Invited site reviews for technical assistance on health and disability concepts at University Centers for Excellence in Developmental Disabilities Education, Research, and Service. Center on Disability & Community Inclusion, The University of Vermont, College of Education and Social Services, Burlington, VT, 2006. Documentation of site visit is available through the Association of University Centers on Disabilities, Washington, DC.  Westchester Institute for Human Development, Center of Disability and Health, School of Public Health, New York Medical College, Valhalla, NY, 2003. The Elizabeth M. Boggs Center on Developmental Disabilities, University of Medicine & Dentistry of New Jersey-Robert Wood Johnson Medical School, Department of Pediatrics, New Brunswick, New Jersey, 2004. Center for Development and Disability, University of New Mexico, Albuquerque, New Mexico, 2004.
Invited Presentations: U.S. Public Health Service. Closing the Gap: A National Blueprint for Improving the Health of Individuals with Mental Retardation. Report of the Surgeon General's Conference on Health Disparities and Mental Retardation. February 2001. Washington, D.C. Krahn G.L. (2001) Oregon Healthy Lifestyles for Persons with Developmental Disabilities. Invited Presentation at Surgeon General's Research Conference on Health Disparities and Mental Retardation, Washington D.C., December 2001. . Krahn, G. L. (2002) Where in the Health is Wellness? Promoting Health and Wellness at the Person, Provider and Policy Levels. Invited keynote address at the North American Federation of Adapted Physical Activity. Corvallis, Oregon, September 26, 2002 . Krahn, G.L. (2003) Changing Concepts in Health, Wellness and Disabilities. Keynote address at the Changing Concepts in Health, Wellness and Disabilities Conference, Bethesda, MD, March 17, 2003. . Krahn, G.L. (2003) Responses to N. Lennox: The Impact of Health and Social Care Delivery on Health Disparities for People with Intellectual Disabilities. International Conference on Health Disparities among Individuals with Developmental Disabilities: An Agenda for Change. White Plains, NY, August, 2003.

Citation. Article Putnam M, Geenen S, Powers L, Saxton M, Finney S, Dautel P. Health and wellness: people with disabilities discuss barriers and facilitators to well being. Journal of Rehabilitation. Jan-Mar 2003;69(1):37-45. Invited Articles: Krahn, G.L., Hammond, L., and Turner, A. (2006) A cascade of disparities: Health and health care access for people with intellectual disabilities. Mental Retardation Research Review, 12(1), 70-82. Krahn, G.L.& Drum, C.E. (submitted) From principles to policies to practices: What will it take to improve the health of persons with intellectual disabilities? Special policy issue of Mental Retardation Research Review, 2007. Krahn GL. Changing concepts in health, wellness and disability. In: RRTC Health and Wellness Consortium, ed. Changing concepts of health & disability: state of the science conference & policy forum. Portland, OR: Oregon Health & Science University; 2003:6-19. Krahn GL. Changing concepts in health, wellness and disabilities: Keynote address. Paper presented at: Changing Concepts in Health, Wellness and Disabilities Conference; March 17, 2003;  Bethesda, MD.

Web site: www.surgeongeneral.gov/topics/mentalretardation/

Problem addressed. Disability is still too frequently equated with poor health by researchers and policymakers. This conceptual entanglement precludes more attention to improving the health of people with disabilities and carefully measuring health status. Disentangling health from disability provides that persons who experience disability are capable of participating fully in their communities, making contributions and living full and rewarding lives.

Basis for accomplishment. From previous cycle: R1:Self-Definition of Health Practices, Opportunities and Barriers Project R2: Health Constructs and Measurement Project.

Award: H133E030030 ID: 108, 01-Oct-03 to 30-Sep-08
Grant Title: Rehabilitation Engineering Research Center in Prosthetics and Orthotics
Host Institution/Grantee Name: Northwestern University
Principal Investigator: Gard, Steven A.
Program Mechanism: Rehabilitation Engineering Research Center
Funding per year: $950,000

Accomplishment. The Shape&Roll Prosthetic Foot for Use in Low-Income Countries

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The development of the Shape&Roll Prosthetic Foot (for adults) was completed during the previous funding cycle. This development project was done in collaboration with the Center for International Rehabilitation, who currently has the RERC on Improved Technology Access for Landmine Survivors. The development of the Shape&Roll prosthetic foot core was finished in the last funding cycle, although significant improvements have been made to the manufacturing of the foot during this cycle. Development of a cosmetic rubber shell for the foot was started in the last funding cycle and was finished in the current reporting period. The process for creating a prosthetic foot shell out of polyurethane rubber was filmed and transferred to the Center for International Rehabilitation. We have also finished two of the three manuals describing how to fabricate a compression molding device and how to create a Shape&Roll prosthetic foot core from a compressed "blank" piece (see Nugget entitled Manuals 1 and 2 of Prosthetic Foot Designer Kit for Low-Income Countries). An independent study of the foot is beginning in Afghanistan (Sandy Gall Afghanistan Appeal) to study 100 Shape&Roll prosthetic feet using our foot cores and a silicone rubber cosmetic shell developed by a colleague in England, Mr. Edward Pennington-Ridge. This study is seeking support of Adopt-A-Minefield, a campaign of the United Nations Association of the United States of America. We are also currently manufacturing five feet to be tested in Sri Lanka and Nepal (with our cores and shells). Prosthetists and prosthesis users in these regions will determine if the Shape&Roll prosthetic foot is appropriate technology for their countries.

Documentation. Two papers have been previously published: Sam, M., Childress, D., Hansen, A., Meier, M., Lambla, S., Grahn, E., Rolock, J. (2004) The Shape&Roll Prosthetic Foot (Part I): Design and Development of Appropriate Technology for Low-Income Countries. Medicine Conflict and Survival, Vol. 20, No. 4, 294-306. Meier, M., Sam, M., Hansen, A., Childress, D. (2004) The Shape&Roll Prosthetic Foot (Part II): Field Testing in El Salvador. Medicine Conflict and Survival, Vol. 20, No. 4, 307-325. Additionally, information can be found on the Shape&Roll Prosthetic Foot on our website: www.medschool.northwestern.edu/depts/repoc/sections/research/projects/ambulate/srfoot_lowincome.html A manuscript describing the polyurethane cosmetic cover is being prepared.

Problem addressed. From Sam et al. (2004): There is a huge unmet need for prosthetics services in low-income countries. In addition to the usual causes of amputation (congenital, agricultural accidents, traffic accidents, disease, etc.), landmines play a large role in some low-income countries [1]. An estimated 15,000 persons die or are maimed from landmine related injuries each year [2]. The actual numbers might be higher given the fact that many incidences occur in remote areas without medical facilities to record them [3]. More than one-third of those who survive landmine injuries require amputation, though the incidence of amputation varies according to the type of mine [4]. Currently in low-income countries, the demand for lower limb prostheses is much greater than the number of prostheses that can be distributed. For example, since 1979, over 65 ICRC rehabilitation projects in 25 countries have manufactured over 180,000 prostheses for 160,000 persons with amputations [5]. The World Health Organization reports that almost all developing countries have rehabilitation services, but that such services reach less than 5% of persons with disabilities, as these services are frequently based in centralized urban hospitals, limiting accessibility to the general population [1]. In countries where average wages are several times less than in industrialized countries, the cost of a prosthesis, varying from $125 to $1,875 US Dollars, is often too expensive for individuals, thus forcing them to choose crutches if they want to stay ambulatory [1]. The use of imported prosthetic feet is often unaffordable for the majority of persons with amputations. Furthermore, these components, which are designed for use in industrialized countries, often do not adapt well in most low-income countries because of differences in conditions of use and cultural issues [7-12]. Hence prosthetic feet intended for use in low-income countries require a specific design tailored to the targeted areas of use. 1. Walsh NE and Walsh WS. Bull World Health Organ 2003; 81: 665-70. 2. Strada G. Sci Am 1996; 274: 40-5. 3. Ascherio A, Bielick R, Epstein A, Snetro G, Gloyd S, Ayotte B, and Epstein PR. Lancet North Am Ed 1995; 346 (16): 721-24. 4. Morbidity and Mortality Weekly Report. MMWR Morb Mortal Wkly Rep 1997; 46: 724-6. 5. Verhoeff T. Geneva: International Committee of the Red Cross, 2002. 6. Meier RH (III) and Smith WK. Phys Med Rehabil Clin N Am 2002; 13: 175-187. 7. Sethi PK, Udawat MP, Kasliwal SC and Chandra R. Prosthet Orthot Int 1978; 2: 125-36. 8. Wollstein LV.N LV. Lepr Rev 1972; 43: 106-13. 9. Vossberg A. Prosthet Orthot Int 1985; 9: 83-6. 10. Meanley S. Prosthet Orthot Int 1995; 19: 176-80. 11. Day HJ. Prosthet Orthot Int 1996; 20: 15-23. 12. Cummings D. Prosthet Orthot Int 1996; 20: 51-60.

Basis for accomplishment. The development of the Shape&Roll Prosthetic Foot was based on several cycles of funding to Northwestern University (RERC on Prosthetics and Orthotics) and the Center for International Rehabilitation (RERC on Improved Technology for Landmine Survivors). In particular, the design was heavily influenced by projects conducted at Northwestern University during the previous cycle (1998-2003) entitled, "Simple Models" and "Rocker Bases in Walking". The work conducted in these projects included modeling and measurements of the roll-over shapes of able-bodied persons under a variety of walking conditions. This information was critical to the design of the prosthetic foot. Additional support for the development of the Shape&Roll prosthetic foot was obtained through a subcontract with the Center for International Rehabilitation, the previous and current RERC on Improved Technology for Landmine Survivors.

Award: H133N000012 ID: 119, 01-Oct-00 to 30-Sep-06
Grant Title: The Missouri Model Spinal Cord Injury System
Host Institution/Grantee Name: The Curators of the University of Missouri
Principal Investigator: Schopp, Laura
Program Mechanism: Model System
Funding per year: $300,000

Accomplishment. The Missouri Model Spinal Cord Injury System (MOMSCIS) produced a manuscript describing the barriers and satisfaction experienced by consumers with spinal cord injury and their personal assistants. The research activities which produced the qualitative evidence for the manuscript were a natural follow-up to the NIDRR-funded Individual Management of Personal Assistant-Consumer Teams (IMPACT) workshop training research completed by MOMSCIS earlier in the grant funding cycle. The citation for the manuscript is listed below.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The MOMSCIS staff conducted a series of workshops early in the NIDRR-funded 2000-2006 grant cycle. The workshops were designed to train consumers with spinal cord injuries (SCI) and their personal assistants about SCI-related issues and improve the working relationship between consumers and assistants. In the course of these workshops, the MOMSCIS staff recognized that many consumers and assistants were prevented from participating in the workshops because of significant barriers. These barriers also affected the personal assistance services (PAS) available to consumers. MOMSCIS staff sought to address four primary research questions through a series of qualitative focus group sessions with consumers and assistants. The focus group questions included: 1) What barriers to consumers encounter in obtaining and maintaining PAS? 2) What barriers do personal assistants encounter in providing quality services? 3) How satisfied are consumers with their PAS? 4) How satisfied are personal assistants with their jobs? The sample consisted of 24 consumers and 15 assistants. Consumers reported experiencing barriers clustered around three primary themes: 1) difficulty finding reliable employees; 2) low compensation for personal assistants; and 3) challenges associated with home care agency and PAS policies. Consumers valued their close, positive working relationships with their personal assistants. Personal assistants listed several obstacles that interfered with providing PAS, including relationship problems, job burnout, inadequate compensation, and restrictive PAS policies. Although personal assistants were dissatisfied with their total compensation or overall working conditions, they reported an overriding sense of meaning and satisfaction in their work. Knowing that one was "doing a good deed" consistently remained a major source of satisfaction.

Documentation. A MOMSCIS Spinal Series newsletter article about the focus groups is available online at: www.muhealth.org/~momscis/series/archives/series22.shtml
A MOMSCIS Spinal Series newsletter article describing the poster presentation of preliminary IMPACT study data is available at: www.muhealth.org/~momscis/series/archives/series21.shtml

Citation. Matsuda SJ, Clark MJ, Schopp, LH, Hagglund, KJ, Mokelke, EK. Barriers and satisfaction associated with personal assistance services: Results of consumer and personal assistant focus groups. OTJR: Occupation, Participation and Health, 25(2), 66-74, 2005.  www.otjronline.com/view.asp?rID=3534

Problem addressed. In Olmstead v. L.C. (1999), the U.S. Supreme Court ruled that public agencies are required to administer programs in the most integrated setting for the needs of individuals with disabilities. The Olmstead decision has been supported by the New Freedom Initiative to restructure long-term care so that barriers to community living are removed for individuals with disabilities and chronic illnesses. In addition, policy makers are increasingly interested in developing programs to encourage participation among individuals with disabilities. Personal assistance services (PAS) enable consumers with disabilities to pursue educational, occupational, and social activities outside the home and to live independently in the community. Individuals with disabilities and their advocates have called for improved access to consumer-directed PAS. However, to accomplish this goal, a great many barriers must be overcome. This research manuscript offers insight into the primary barriers to participation identified by consumers and assistants.

Award: H133A020501 ID: 135, 01-Oct-02 to 30-Sep-07
Grant Title: New York Traumatic Brain Injury Model System
Host Institution/Grantee Name: Mount Sinai School of Medicine/ Wayne A. Gordon
Principal Investigator: Gordon, Wayne
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. Based on analyses of data from our study on post-TBI fatigue, preliminary knowledge of the nature of this commonly reported problem has been disseminated through two staff presentations at a professional conference and grand rounds. Rehabilitation researchers and clinicians comprise the primary target audience.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. Preliminary data analyses on 218 study participants revealed that compared to the non-disabled control sample, individuals with TBI experienced reduced speed in cognitive performance tasks as a consequence of cognitive exertion. Thus, speed declined as cognitive fatigue increased in the TBI sample, but not in the controls. Also, although objective measures of fatigue increased, reports of subjective feelings of fatigue did not.

Documentation. These results were presented twice during the reporting period: Ashman, T.A. (2006, March). A study of post-TBI fatigue. Presentation, Second Federal Interagency Conference on TBI, Bethesda, MD. Gordon, W.A. (2006, May). Post-TBI fatigue; initial findings. Grand rounds, University of Texas Medical Branch, Galveston, TX. The letter of invitation to present at Grand Rounds is on file in our offices; Dr. Ashman's presentation is noted in the program of the Second Federal Interagency Conference on TBI and is available on the conference website. www.tbi-interagency.org/pdf/tashman.pdf [forbidden public link]

Citation. Ashman, T.A. (2006, March). A study of post-TBI fatigue. Presentation, Second Federal Interagency Conference on TBI, Bethesda, MD. Gordon, W.A. (2006, May). Post-TBI fatigue; initial findings. Grand rounds, University of Texas Medical Branch, Galveston, TX.

Web site: www.tbi-interagency.org/pdf/tashman.pdf [forbidden public access]

Problem addressed. Fatigue has been shown repeatedly to be a frequently encountered problem after brain injury. However, basic knowledge of this common experience is insufficient. The NY TBI Model System's study is important, as it one of only a handful exploring the mechanisms and characteristics of fatigue after TBI. Information about fatigue is critical to clinical management and the education of consumers.

Basis for accomplishment. As part of NYTBIMS research a Study of Post-TBI Fatigue and its Treatment is being implemented. Data analyses have begun on a sample of 164 people with TBI and 54 controls (non-disabled). The goal is to more clearly understand the correlates (e.g., depression, sleep problems and pain) of mental fatigue as well as other forms that fatigue takes. Data analyses were organized into these two presentations by NYTBIMS staff (Ashman, Gordon).

Award: H133E030017 ID: 136, 01-Nov-03 to 31-Oct-08
Grant Title: RERC: Improved Technology Access for Landmine Survivors
Host Institution/Grantee Name: Center for International Rehabilitation
Principal Investigator: Wu, Yeongchi
Program Mechanism: Rehabilitation Engineering Research Center
Funding per year: $950,000

Accomplishment. Developed the CIR-Wu Prosthetic Casting System as an evolution from the original CIR Sand Casting System developed during the previous RERC cycle. Both casting systems are prosthetic socket fabrication tools that significantly reduce the overall time from evaluation and casting of the patient to finished prosthesis for delivery to the patient. The systems were designed for use by prosthetic technicians in developing countries to help them meet the service provision needs of amputees affected by landmines. Although the systems were developed for prosthetic service providers in low-income countries, they can easily be marketed for use in the developed world.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The CIR-Wu Prosthetic Casting System offers several improvements over its predecessor. The new system is less expensive, more compact and portable, and it weighs much less than the previous system. It eliminates the need for silica sand and an air compressor. It requires minimal assembly and can be transported in a backpack for outreach prosthetic services. Most importantly, the CIR-Wu Prosthetic Casting System produces a better fitting socket than the CIR Sand Casting System, and it addresses a concern previously raised by prosthetists, the sand container prohibits the prosthetist from manipulation the residual limb and cast with his hands. The accomplishment was evidenced by: CIR-Wu Casting System was successfully tested in CIR's laboratory. A consulting prosthetist conducted trials with a volunteer transtibial amputee. The prosthetist provided positive feedback on the use of the system, while both the prosthetist and the amputee claimed the socket had a more intimate fit than a similar socket made with the original Sand Casting System. The RERC research prosthetist conducted a comparative study between the new CIR-Wu Prosthetic Casting System, the CIR Sand Casting System, and traditional casting by comparing diametral and circumferential measurements of the positive models for each method with each other and with the residual limb. Anterior/Posterior and Medial/Lateral diameters were taken at the mid-patellar tendon level and tibial plateau respectively. Circumferences were measured at the tibial plateau level, as well as above and below the tibial plateau level. Casts were made with (1) regular plaster bandage, (2) regular and elastic plaster bandage, (3) CIR Sand Casting, and (4) CIR-Wu Prosthetic Casting System. For all measurement levels the CIR Sand Casting System resulted in a positive model with dimensions larger than the residual limb. Conversely, for all measurement levels the CIR-Wu Prosthetic Casting System consistently resulted in diameters and circumferences that were less than the residual limb. The CIR-Wu Prosthetic Casting System resulted in measurements equal to or less than those produced by traditional casting techniques. The new CIR-Wu Prosthetic Casting System was transferred to Ultraflex Systems, Inc., in February 2006, along with the original CIR Sand Casting System for further evaluation and commercialization. The results of the comparative testing were used to demonstrate the increased accuracy of the new CIR-Wu Prosthetic Casting System. A provisional patent was filed claiming that the new system is suitable for socket fabrication for many levels of amputation; the original CIR Sand Casting System for designed only for transtibial socket fabrication. Video demonstration received very positive feedback from Mr. Sepp Heim, former ISPO President, who has extensive field experience in developing countries. Presentation of the new system to CSPO faculty member visiting CIR in May 2005 received very positive comments.

Documentation. CIR Internal report on the comparative study between the CIR-Wu Prosthetic Casting System, CIR Sand Casting System and traditional casting techniques. Posted on document repository of the RERC State-of-the-Science Project Group The video tape is available at the RERC State-of-Science Project Group accessible through CIR's RERC web site: http://rerc.cirnetwork.org This SoS working group web site can be accessed with an issued password. The video tape and training module set is available upon request to Yeongchi Wu, M.D. at ywu@cirnetwork.org

Citation. Sand-casting technique for transtibial prosthesis, a report by ISPO report on VIETVOT field testing (may 2003 to May 2004) of the CIR Sand Casting System in Prosthetics and Orthotics International, August 2005.

Problem addressed. This accomplishment address the following needs: 1) Lack of properly trained prosthetists to provide services 2) Limited financial resources to support long-term service provision 3) Multiple clinic visits required to properly fit and align the prosthesis 4) Dependency on imported prosthetic casting supplies

Basis for accomplishment. Prior development work for CIR Sand Casting System started in previous funding cycle and continued in current funding cycle through dissemination and technology transfer. Feedback from prosthetists in the field suggested the necessity for continued improvement. Also, project D1.1 development of socket fabrication system for transfemoral amputees provided the impetus for the current design of the CIR-Wu Prosthetic Casting System.

Award: H133A040016 ID: 161, 01-Jan-05 to 30 Jun 08
Grant Title: Medicaid Quality Indicators for Individuals with Disabilities
Host Institution/Grantee Name: George Mason University
Principal Investigator: Palsbo, Susan E.
Program Mechanism: Disability Rehabilitation Research Project
Funding per year: $299,999

Accomplishment. During the current reporting period, the DRRP changed data collection and health care quality measurement practice in the State of Wisconsin, which is serving as the "alpha" test site of the CAHPS-PWMI questions. Wisconsin is requiring the SSI population in 6 counties (including the city of Madison) to enroll in managed care plans. Since many people on SSI have disabilities, Wisconsin's Dept. of Human Services is concerned about the quality of medical care. In response to their request for devising a pre-post enrollment survey of consumer ratings of quality, this DRRP worked closely with the CAHPS-PWMI research team to develop disability-related questions, as well as questions to adjust the responses for functional status in the Wisconsin survey. The Consumer Assessment of Healthcare Providers and Systems (CAHPS) program is a public-private initiative to develop standardized surveys of patients' experiences with ambulatory and facility-level care. The CAHPS program was designed to (1) Make it possible to compare survey results across sponsors and over time; and (2) Generate tools and resources that sponsors can use to produce understandable and usable comparative information for consumers. The CAHPS program is funded and administered by the U.S. Agency for Healthcare Research and Quality (AHRQ), which works closely with a consortium of public and private organizations including the Centers for Medicare and Medicaid Services, purchasing coalitions such as the Pacific Business Group on Health, and the Centers for Disease Control and Prevention. The development program has been funded since 1996. It is, by far, the most widely used tool to collect patient ratings of quality. Health care organizations, public and private purchasers, consumers, and researchers use CAHPS results to assess the patient-centeredness of care; compare and report on performance; and improve quality of care. CAHPS instruments include the health plan CAHPS, Medicare CAHPS, Medicaid CAHPS, CAHPS for Children with Special Needs, and Behavioral Care CAHPS. CMS uses the Medicare CAHPS when preparing consumer-oriented report cards for public report cards. Businesses use the health plan CAHPS to select which insurers to offer to their employees, and half of the states use the Medicaid CAHPS to monitor contract performance. CAHPS is also used by the leading health plan accreditation organizations, including NCQA. AHRQ, with support from NIDRR, is currently developing a CAHPS for People with Mobility Impairments (PWMI), as the first of a planned series of supplemental questions targeted to the unique needs of adults with disabilities. This DRRP supports the PI's involvement as both an advisor and a beta-tester of the CAHPS-PWMI.

Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. Question content and disability-sensitive wording of items that were included in the State of Wisconsin's survey were derived from the focus groups carried out under this DRRP during Year 1, as well as items developed under the previous "RRTC on Managed Care and Disability." For example, the question asking about use of "special equipment" was modified to "equipment", since people with disabilities do not consider it "special." The following additional questions on pain management, clinical accessibility, and wellness were added to the Wisconsin survey, based directly on the work that we have carried out under this grant and under the previously- funded RRTC on Managed Care and Disability: 12. In the last 6 months, how often did pain limit your ability to do things that you wanted to do? 13. In the last 6 months, do you think that your personal doctor or nurse understood the impact that pain has on your life? 14. In the last 6 months, were there physical barriers that made it hard or impossible for you to get into your personal doctor or nurse's office? 15. In the last 6 months, were there physical barriers that made it hard or impossible for you to move around in your personal doctor or nurse's office? 16. In the last 6 months, were you able to get onto the examination table in your doctor's office, either by your self or with the help of others, for a physical examination? 17. In the last 6 months, did you or your personal doctor or nurse talk about the exercise or physical activity that you get? In addition, the DRRP modified the standard question on the availability of interpreters to include interpreters for the hard-of-hearing or deaf: 22. An interpreter is someone who repeats or signs what one person says in a language used by another person. In the last 6 months, did you need an interpreter to help you speak? Several questions on the quality of mobility equipment were included in the Wisconsin survey, as a result of the DRRP focus groups: 45. In the last 6 months, how often was it easy to get the mobility equipment you needed through Medical Assistance/T19/Medicaid? 46. In the last 6 months, how often was it easy to get your mobility equipment repaired or replaced through Medical Assistance/T19/Medicaid? Because DRRP focus group participants complained about the lack of timely transportation, we inserted this question into the Wisconsin survey: 55. In the last 6 months, how often did the transportation from Medical Assistance/T19/Medicaid pick you up for your appointment within 15 minutes of the time they gave you? Finally, the Wisconsin survey included the following items about care coordination, a new topic raised by the DRRP focus groups in Year 1: 57. In the last 6 months, did anyone from Medical Assistance/ T19/Medicaid help to coordinate your care among these different providers or services? 58. In the last 6 months, how often was it easy to get someone from Medical Assistance/T19/Medicaid to help coordinate your care among these different providers or services? A total of 5674 people were selected for the Wisconsin survey (2529 in Dane County (Madison), 3145 in south eastern counties). The state expects a response in the neighborhood of 40% completed surveys. Analysis of the psychometric properties of the survey will be used to inform the survey which this DRRP will field to several thousand adults with disabilities during the next reporting period.

Documentation. Copies of the Wisconsin survey instrument can be obtained from the following people: Ruthanne Landsness Work: 608/258-3350 E-Mail: landsrm@dhfs.state.wi.us or: AHRQ - CAHPS project manager, Chris Crofton Work: 301-427-1323 E-Mail: CCrofton@ahrq.gov Sue Palsbo, PhD Work: 703-993-2173 email: spalsbo@gmu.edu

Citation. O'Day B, Palsbo SE, Dhont K, and Scheer J. 2002. Health Plan Selection Criteria by People with Impaired Mobility. Medical Care 40(9):732-742. Palsbo SE and Kroll T. How Medicaid Adults with Disabilities Measure Health Plan Quality. Proceedings, AcademyHealth Annual Meeting, June 2005. Boston MA. Ho PS, Palsbo SE, Beatty PW. Extending the CAHPS to adults with physical disabilities: The MnDHO field test. Proceedings, American Public Health Association's 131st Annual Meeting, November 15-19, 2003. San Francisco, CA. Palsbo, SE Defining "disability literacy" in health plans to meet HP2010 goals. Proceedings, American Public Health Association Annual Meeting, November 2003. San Francisco.

Problem addressed. An unknown number of people on SSI have emotional, behavioral, cognitive and/or physical disabilities. This mail survey incorporates screening questions for respondents (or a proxy) to self-identify as having an impairment. If the respondent is screened in, they are asked focused questions about the quality of care and adequacy of access to health-related services while enrolled in Medicaid. Wisconsin will re-administer the survey in 12 months, after the respondents have been enrolled in managed care (mandatory requirement by the state). At that time, Wisconsin will be able to identify access gaps and to measure the quality of specific types of services that populations of people with different types of disabilities need, and how those changed before and since enrollment in managed care. The information will be made public, so people with disabilities and their advocates can review and comment on the quality and access of disability-related services in their county.

Basis for accomplishment. "Buy-in" by a state known for being a leading innovator in Medicaid programs is crucial to wide-spread adoption of the final instrument; buy-in by the federal agency leading the CAHPS development (AHRQ).

Award: H133A031713 ID: 172, 01-Jan-04 to 31-Dec-09
Grant Title: A Prospective Randomized Controlled Trial of the Effectiveness of Amantadine Hydrochloride in Promoting Recovery of Function Following Severe Brain Injury
Host Institution/Grantee Name: Solaris Health System
Principal Investigator: Giacino, Joseph
Program Mechanism: Disability Rehabilitation Research Project
Funding per year: $599,994

Accomplishment. We have developed and published the first standardized assessment scale that reliably distinguishes patients in MCS from those in VS and improves early prediction of functional outcome- the revised JFK Coma Recovery Scale (CRS-R). Since publication of the CRS-R in 2004, it has been utilized by practicing clinicians, researchers, epidemiologists and policy makers in the U.S., Europe, Asia, South America and Australia.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. Rates of misdiagnosis among individuals with disorders of consciousness have been estimated to range from 15-43%. There is growing awareness of the importance of distinguishing patients with subtle, easily-overlooked signs of consciousness from those who lack any evidence of conscious behavior. This is due, in part, to recent evidence indicating that functional outcome is significantly more favorable for patients in the minimally conscious state (MCS) as compared to those in the vegetative state (VS). A variety of assessment instruments have been developed to address these concerns, however, none have been shown to accurately differentiate patients in VS and MCS. Published evidence indicates that the CRS-R is a valid and reliable means of assessing neurobehavioral responsiveness. Our published psychometric study of the CRS-R in 2004 demonstrated that it can be administered reliably by trained examiners and that repeated measurements yield stable diagnostic classifications. The same study found that 12% of patients diagnosed with VS on the Disability Rating Scale were actually in MCS when assessed with the CRS-R (Giacino et al., 2004). As a result of publication of the CRS-R, an objective and more accurate means of establishing diagnosis and predicting functional outcome is available. Evidence that the CRS-R is relevant to an external audience is provided by the following: 1) The CRS-R has been translated (by international investigators) into 6 different languages including Spanish (Primary author: Jorge Niklison, Fleni Rehabilitation Hospital, Buenos Aires, Argentina, 2006), French (Carolyn Schnakers, University of Liege, Brussels, Belgium, 2005) Italian (Francesco Lombardi, Hospital of San Sebastiano, Reggio Emilia, Italy, 2005) German (Petra Maurer, Fachkrankenhaus Neresheim, Neresheim, Germany, 2005) Dutch (Steven Laureys, University of Liege, Brussels, Belgium, 2005) and Norwegian (Anne-Kristine Schanke, Sunnaas Rehabilitation Hospital, Oslo, Norway, 2005). 2) The CRS-R has been adopted for use in government-funded epidemiologic studies of VS and MCS in Belgium and Italy. Preliminary results of the Italian "GISCAR" study of the incidence, prevalence and costs of care in patients in VS and MCS were reported at a national conference held in Reggio Emilia, Italy on March 23-25, 2006. Diagnostic data for this study were obtained using the CRS-R. The Belgian government, through the Belgian Federal Department of Health, Food Chain Saftey and Environment, is using the CRS-R to collect epidemiologic data on VS and MCS. A national meeting held in Brussels on 11/30/05 released data on incidence and outcome in VS and MCS after one year of surveillance. 3) Evidence that the CRS-R is advancing knowledge is demonstrated by 2 recently-published studies discussing use of the CRS-R in clinical practice and in TBI outcomes research. A 2005 Australian study of patients who were in MCS for at least one month after TBI used the CRS-R to document long-term outcome. Unexpectedly, results showed that duration of time in MCS did not predict psychosocial outcome at 2-5 years post-injury and that a large percentage of MCS patients eventually regained functional independence. A 2005 review of behavioral assessment methods completed by European researchers recommended use of the CRS-R as a "new promising tool" for evaluation of  consciousness after severe brain injury.
Documentation. 1) Information concerning the CRS-R translations can be obtained by contacting the authors of each version: Spanish (jniklison@fleni.org.ar) French(c.schnakers@student.ulg.ac.be) Italian (Francesco.Lombardi@ausl.re.it) German (petra.maurer@fkne.srh.de) Dutch (Steven.Laureys@ulg.ac.be) Norwegian (Anne-Kristine.Schanke@sunnaas.no) 2) Information concerning use of the CRS-R in epidemiologic research can be obtained by contacting the Belgian Federal Expert Platform (Contact: delphine.simoens@health.fgov.be) and the Training and Communication Offices of the Reggio Emilia Local Health Unit (Contact: Francesco.Lombardi@ausl.re.it). 3) Evidence that the CRS-R is being utilized in clinical practice and TBI outcome research can be found in recent peer-reviewed literature. Specific citations are listed below: Lammi M, Smith VH, Tate RL, Taylor CM. The minimally conscious state and recovery potential: A follow-up study 2 to 5 years after TBI. Archives of Physical Medicine and Rehabilitation Medicine 2005;86:746-754. Majerus S, Gill-Thwaites H, Andrews K, Laurey S. Behavioral evaluation of consciousness in severe brain damage. Progress in Brain Research 2005;150:397-414.

Citation. Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale- Revised: Measurement Characteristics and Diagnostic Utility. Archives of Physical Medicine and Rehabilitation, 2004;85(12):2020-2029. Note: The CRS-R is publically accessible at: www.njrehab.org/tbims/ComaRecoveryScale.pdf

Web site: 1. www.njrehab.org/tbims/ComaRecoveryScaleArticle.pdf

Problem addressed. There are few standardized assessment measures designed specifically for patients with disorders of consciousness that have demonstrated sufficient psychometric integrity for use in diagnostic, prognostic and treatment effectiveness studies. The above references and publications indicate that the CRS-R performs well in these roles and appeals to a wide user base.

Basis for accomplishment. This accomplishment is related to two of our planned project activities: 1) In combination with the DRS, we are using the CRS-R to analyze the magnitude of the AH treatment effect. We have predicted that the drug impact on recovery will be larger (as shown by improvements in DRS and CRS-R scores) in the amantadine versus placebo group, in patients who are in MCS vs. VS, and in those who are treated early vs. late. 2) We also plan to determine whether specific functional milestones characterized as important to caregivers are achieved with greater frequency in the AH than placebo group. Survey and focus group data have identified "communication ability" as the outcome of greatest importance to family members. As such, this outcome will be added to the data collection set. The CRS-R will be used to obtain data on communication ability through individual item analysis of the Communication subscale).

Award: H133E020724 ID: 208, 01-Nov-02 to 31-Oct-07
Grant Title: Machines Assisting Recovery from Stroke Rehabilitation Engineering Research Center (MARS-RERC)
Host Institution/Grantee Name: Rehabilitation Institute Research Corporation (RIRC)
Principal Investigator: Rymer, W. Zev
Program Mechanism: Rehabilitation Engineering Research Center
Funding per year: $888,102

Accomplishment. T-WREX: A Novel Device for Motor Training after Stroke An important goal in rehabilitation engineering is to develop technology that allows individuals with severe motor impairment to practice arm movement without continuous supervision from a rehabilitation therapist. We have successfully developed such technology. The device, called "T-WREX", consists of an orthosis that assists in arm movement across a large workspace, a grip sensor that detects hand grip pressure, and software that simulates functional activities such as cooking and reaching using simple virtual reality. Initial clinical testing at two sites (University of California at Irvine with 5 individuals with a stroke and the Rehabilitation Institute of Chicago with 15 individuals with a stroke) indicates that people can significantly improve their movement ability by practicing movement with the device, as measured by established clinical scales. A company (Hocoma A.G.) is moving quickly to create a product based on T-WREX, with an expected release date in 2007. Watch a short demo video of the NIDRR-supported prototype T-WREX at www.smpp.northwestern.edu/MARS/Project5desc.htm

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. Arm weakness caused by stroke can limit the ability to complete many daily tasks. Research suggests it is possible for stroke survivors to improve arm movement with intensive training. However, intense training requires close supervision from a therapist. Insurance providers limit coverage for such treatment. We have developed a device that allows stroke survivors to practice effective arm movement therapy in a clinic with indirect supervision. The device consists of an orthosis that assists in arm movement across a large workspace, a grip sensor that detects hand grip pressure, and software that simulates functional activities using simple virtual reality. The arm orthosis is an instrumented, adult-sized version of the Wilmington Robotic Exoskeleton (WREX), and passively relieves the weight of the arm using elastic bands. WREX was produced with previous NIDRR support by Dr. Tariq Rahman as an assistive device for children with muscular dystrophy. The software for T-WREX is derived from a previous, web-based software called Java Therapy, supported by the Microsoft Corporation. Initial clinical testing of the device at U.C. Irvine (5 individuals with a stroke) and RIC (15 individuals with a stroke) indicates that people can significantly improve their movement ability, as measured by clinical scales and quantitative measures. These individuals practiced 3 times per week for 8 weeks with the device. For the pilot study at U.C. Irvine, mean change in Fugl-Meyer score was 5 points ±2 SD, p < 0.01; mean change in range of motion of reaching was 10%, p < 0.001. The T-WREX device is different from previous clinical and robotic approaches to automating rehabilitation therapy in several ways. It is different from the clinical use of devices such as arm skateboards and overhead slings because it uses an instrumented orthosis with a large 3D workspace. This approach makes it possible to provide quantitative feedback to the patient and therapist about movement recovery, and also engages the user in simple virtual reality games that mimic functional activities. The large workspace makes a greater range of movement possible than with standard clinical devices. This approach is different from recent attempts to use robotic devices to automate therapy because it uses a passive device that does not generate power. The system can be manufactured at less cost than an actuated system and is safer. The device allows a larger range of motion than previous robotic devices, including feeding and washing motions. The incorporation of a simple hand grasp sensor contributes to the ability of the system to facilitate functional movement. Three companies expressed interest in making the device a product. The University of California signed an agreement to negotiate exclusively with Hocoma AG for a license for the T-WREX intellectual property (software, mechanical design, and patent application). Hocoma signed a non-disclosure agreement with the University of California, and paid for the right arm prototype developed by U.C. Irvine to be shipped to Hocoma for a two week time period in June 2006. Hocoma then delivered the device to RIC for further clinical testing. Hocoma has begun building a commercial prototype of the device based on the NIDRR-funded design. The commercial prototype includes modifications that make the device easier to adjust for different patients. Hocoma hopes to begin selling the device in 2007.

Documentation. The evidence that shows that the accomplishment occurred or matured in the current reporting period, and where that evidence can be found, is as follows: 1) Acceptance for publication in a leading journal of the pilot efficacy study at U.C. Irvine. See: Sanchez RJ, Liu J, Rao S, Shah P, Smith R, Cramer SC, Bobrow JE, Reinkensmeyer DJ (2006) "Automating arm movement training following severe stroke: functional exercises with quantitative feedback in a gravity-reduced environment", to appear, IEEE Transactions on Neural and Rehabilitation Engineering (available from Reinkensmeyer) 2) Completion of the randomized, controlled testing protocol at the RIC by 15 individuals with a stroke, out of a planned 30, as verifiable by the Period Review to the Northwestern Institutional Review Board. 3) Refining of the robustness and usability of the hardware and software of the current device, as verifiable by Sarah Housman, the Occupational Therapist in charge of clinical testing at RIC. Specific examples of progress during the reporting period include strengthening the mechanical interface to the patient, improving the grip force sensor system, and making the software scalable to individual patient's abilities, more easily usable, improved graphics quality, and with more game variety. 4) Filing of a provisional patent application on the T-WREX system by University of California. The application is confidential but can be confirmed by Doug Crawford, Licensing Officer, University of California doug.crawford@ucop.edu 5) Signing of the intent to license exclusively with Hocoma by University of California. The agreement is confidential, but verifiable by Doug Crawford, University of California. 6) Work by Hocoma to develop a first commercial protoType.  This work is confidential and thus the prototype drawings cannot be made public as this time. The fact that the work is in progress can be verified by Dr. Gery Colombo, CEO, Hocoma, A.G. gery.colombo@hocoma.ch 7) Citation of the original Java Therapy publication, on which the new T-WREX software is based, by 6 articles in 2005, out of a total of 31 citations since the article was published, verifiable by searching Google Scholar with the words "Reinkensmeyer: Web-based telerehabilitation for the upper extremity after stroke." The original article is: Reinkensmeyer DJ, Pang CT, Nessler CA, Painter CC (2002) Web-based telerehabilitation for the upper-extremity after stroke, IEEE Transactions on Neural Science and Rehabilitation Engineering, vol. 10, no. 2, pp. 102-108.

Citation. Sanchez RJ, Liu J, Rao S, Shah P, Smith R, Cramer SC, Bobrow JE, Reinkensmeyer DJ (2006) Automating arm movement training following severe stroke: functional exercises with quantitative feedback in a gravity-reduced environment, to appear, IEEE Transactions on Neural and Rehabilitation Engineering

Problem addressed. The problem that this device addresses is providing access to effective movement therapy for the arm without need for an always-present rehabilitation therapist. The device allows individuals with a stroke or other neurologic injuries to effectively exercise their arm, without the costs associated with one-on-one therapy.

Basis for accomplishment. The development and clinical testing of T-WREX is supported by the NIDRR RERC on Rehabilitation Robotics at the Rehabilitation Institute of Chicago, with a sub-contract to the University of California at Irvine (Project V). The basic mechanical structure of WREX was invented by Dr. Tariq Rahman of the A.I. Dupont Institute for Children with previous NIDRR RERC support. The initial software design for the T-WREX software was developed by Dr. Reinkensmeyer's laboratory with a grant from the Microsoft Corporation.

Award: H133A020509 ID: 223, 01-Oct-02 to 30-Sep-07
Grant Title: UAB TBI Model System
Host Institution/Grantee Name: University of Alabama at Birmingham
Principal Investigator: Novack, Thomas
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. Accomplishment 1: As a result of the Orientation Log (O-Log), we have improved the ability to assess orientation during the early stages of the recovery following the TBI.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. Accomplishment 1: The Orientation Log (O-Log) is a 10-item scale that takes 5 minutes (at most) to administer and is intended for use at the bedside of people recovering from TBI. It has undergone rigorous development. Reliability within and between raters has been established. The scale has been normed on a non-injured population, establishing a clear demarcation for what can be considered an abnormal performance. Validity of the O-Log was established by comparing it to an accepted (although flawed) assessment of orientation and noting that estimates of post-traumatic amnesia duration was virtually identical using the two instruments. Expected improvement in orientation during rehabilitation has been provided as a guidepost for clinicians, as well as the clinical importance of a decrease in orientation. Scores on the O-Log during acute rehabilitation have proven to be predictive of outcome (cognitive and community) measured at 6 and 12 months after injury. This has resulted in 6 publications and 8 professional presentations, including a publication during the past year and a presentation at an international neuropsychology conference. The O-Log was added to the list of tests available to the community at large on the COMBI website (www.tbims.org/combi), which recorded 2,198 visits to the O-Log page in the last year and 1,137 downloads of the scale. The O-Log has been accepted by the TBI Model Systems and is being used at multiple sites. The published work from UAB in this area has been cited in 10 professional publications outside of UAB.

Documentation. The O-Log has been added to the list of tests available to the community at large on the COMBI website (www.tbims.org/combi). Currently, Researchers' (external to UAB) citations relative to these instruments number 19; representative citations are:
1. Elhan AH, Kutlay S, Kuckdeveci AA, Kutlay S, Kucukdeveci AA, Cotuk C, Ozturk G, Tesio L, Tennant A. Psychometric properties of the Mini-Mental State Examination in patients with acquired brain injury in Turkey. Journal of Rehabilitation Medicine, 2005; 37(5): 306-311.
2. Scheuringer M, Grill E, Boldt C, Mittrach R, Mullner P, Stucki G. Systematic review of measures and their concepts used in published studies focusing on rehabilitation in the acute hospital and in early post-acute rehabilitation facilities. Disability and Rehabilitation, 2005; 27(7-8): 419-429.
3. Sherer M, Nakase-Thompson R, Yablon SA, Gontkovsky ST. Multidimensional assessment of acute confusion after traumatic brain injury. Archives of Physcial Medicine and Rehabilitation, 2005; 86(5):896-904.

Citation. Novack TA, Dowler RN, Bush BA, Glen ET, Schneider JJ. Validity of the Orientation Log relative to the Galveston Orientation and Amnesia Test. Journal of Head Trauma Rehabilitation, 2000; 15: 957-961. Alderson AL, Novack TA. Measuring recovery of orientation during acute rehabilitation for traumatic brain injury: value and expectations of recovery. Journal of Head Trauma Rehabilitation, 2002; 17-210-219. Israelian MA, Novack TA, Glen ET, Alderson AL. Changes in orientation during acute rehabilitation after traumatic brain injury. Rehabilitation Psychology, 2000; 45: 284-291. Alderson AL, Novack TA. Measuring recovery of orientation during acute rehabilitation for traumatic brain injury: value and expectations of recovery. Journal of Head Trauma Rehabilitation, 2002; 17: 210-219. Alderson AL, Novack TA. Reliable serial measurement of cognitive processes in rehabilitation: the Cognitive-Log. Archives of Physical Medicine and Rehabilitation, 2003; 84: 668-672. Lee, D, LoGalbo, AP, Baños, JH, Novack, TA. Prediction of cognitive abilities one year following TBI based on cognitive screening during rehabilitation. Rehabilitation Psychology, 2004; 49: 167-171.

Web site: www.tbims.org/combi/list.html

Problem addressed. Accomplishment 1 focuses on the need to establish reliable and valid measures of performance that are associated with real-world outcomes for people with TBI. In a series of studies encompassing the entire funding period for the UAB TBI Model System (including the past year), bedside cognitive screening has been established as an important component of rehabilitation that has predictive value for cognitive and functional outcome up to 12 months after injury. The screening devices developed have been accepted by the professional community (including the Model System programs) and are being employed at multiple sites. The scales are available free of charge at the COMBI website.

Basis for accomplishment. Provision of materials to the Center for Outcome Measurement in Brain Injury (COMBI) for inclusion in their website.

Award: H133A020508 ID: 224, 01-Oct-02 to 30-Sep-07
Grant Title: University of Washington Traumatic Brain Injury Model System
Host Institution/Grantee Name: University of Washington
Principal Investigator: Bell, Kathleen
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. Research and Dissemination of Factors Contributing to Employment after TBI. The investigators at the University of Washington have made core contributions to the understanding of the factors involved in employment after traumatic brain injury. This basic information has particularly benefited other scientists, state and other vocational agencies, and service providers for vocational rehabilitation.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. 1. Dr. Doctor compares 1 year employment outcome after TBI for people employed at injury with that expected based on a risk adjusted model of the U.S. population. The findings indicate that the risk of unemployment is substantially higher after TBI (42% of TBI cases were unemployed versus 9%). The relative risk (RR) was higher among males, those with a higher education or more severe injuries and more early cognitive or functional impairment. Although excess unemployment appears higher among the less educated, the RR is actually higher in those with more education due to the small expected unemployment rate in the more highly educated. 2. Ms. Machamer's report on employment stability 3-5 years after TBI examined the factors that predict time spent working and the ability to maintain employment once a person returns to work. Amount of time worked was related to injury severity, neuropsychological (NP) function at 1 month and pre-injury characteristics (prior work stability and earnings). The ability to maintain employment was related to premorbid characteristics (being older, higher pre-injury income, or a preinjury job with benefits) and better NP function at 1 month. 3. Dr. Fraser's work examined the effects of job complexity on returning to employment, maintaining employment, and whether the levels of pre-morbid job complexity are stable after injury. He showed that, among persons with TBI employed at the time of injury, 61% maintain work, 26% were unable to sustain work, and 13% never returned. In the 1st group, most were able to "hold on" to job complexity demand with a small percentage showing less position complexity. In the 2nd group, there was a progressive reduction in job hours and complexity, indicating that, although accommodations were made, those were not enough to allow successful employment. The importance of these studies is: 1st, they supply information to help predict whether the individual is likely to have employment problems and identify contributing factors, helping clinicians design successful and less costly treatment plans. 2nd, these results have implications for appropriate resource allocation to individuals. For instance, if successful employment is highly unlikely, the resources may be better used to support non-work participation of the individual. 3rd, as these studies were based on representative samples of people with TBI, they provide accurate estimates of the potential for successful employment and the nature/magnitude of employment problems after TBI. The results could be used by government agencies to allocate funds for services where most needed; 4th, the results could be used to design future intervention studies by identifying factors that need to be controlled to enhance treatment effects. This work was presented by Drs. Doctor, Dikmen, and Fraser during the 1st international symposium for employment after TBI in Vancouver, B.C. in 2005 to the 225 attendees, entitled "Toward a Fuller Understanding of  TBI's Impact on Employment". Few groups in the world have contributed this level of knowledge translation to understanding employment after TBI. Two papers have been published and the 3rd is accepted for publication. (All occurred during this Model System cycle). The Machamer and Doctor papers have been cited in the Institute of Medicine Report on HRSA grantees which is being used to formulate public policy and Dr. Doctor's work was highlighted on the BIAUSA's research website.

Documentation. 1. Dr. Doctor's article: a. BIAUSA Website: www.biausa.org/Pages/modelsystems/tbi_ms_138.php b. Institute of Medicine Citation.   Eden, Jill and Stevens, Rosemary, ed. Evaluating the HRSA Traumatic Brain Injury Program. Washington, DC: The National Academies Press, 2006. (WEB SITE:   http://fermat.nap.edu/catalog/11600.html) 2. Ms. Machaer's article (www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16519260&query_hl=39&itool=pubmed_docsum):a. Institute of Medicine Citation.   Eden, Jill and Stevens, Rosemary, ed. Evaluating the HRSA Traumatic Brain Injury Program. Washington, DC: The National Academies Press, 2006. (WEB SITE:   http://fermat.nap.edu/catalog/11600.html) 3. Vocational Outcomes in Traumatic Brain Injury, Vancouver, BC, 2005. www.tbicvancouver.com/

Citation. Doctor, J., Castro, J., Temkin, N., Fraser, R., Machamer, J., Dikmen, S. Workers' risk factors for unemployment after traumatic brain injury: A normed comparison J Int Neuropsychol Soc 2005; 11:1, 1-6
Machamer, J., Temkin, N., Fraser, R., Doctor, J., Dikmen, S. Stability of employment after traumatic brain injury. J Int Neuropsychol Soc 2005; 11:7, 807-816.
Fraser, R., Machamer, J., Temkin, N., Dikmen, S., Doctor, J. Return to work in traumatic brain injury (TBI): A perspective on capacity for job complexity. J Head Trauma Rehabil., in press.

Web site: www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=16248910

Problem addressed. A persisting problem that has been resistant to many attempts at amelioration is the level of unemployment among persons with TBI. The prevalent rate of unemployment ranges between 65-75%; these statistics are somewhat deceiving as one aspect of the issue is the difficulty that persons with TBI have in maintaining employment. Although a number of interventions have been used in this population, the factors involved in successful return to employment has been elusive. Vocational counselors and state vocational agencies have been reduced to "best-guessing" what services to offer to which clients. In this era of diminishing resources for vocational rehabilitation, it is more important than ever to be able to understand the characteristics of both the client and the position to best utilize these funds and programs. The information produced by this research program will offer guidance to individual providers and to government and other agencies in developing successful programs to enhance a return to productive activity for those with TBI.

Basis for accomplishment. This accomplishment is based on the peer-reviewed publications noted, dissemination to an international audience, highlighting by the national consumer organization, and inclusion by the Institute of Medicine in their long-awaited review of the state TBI programs and recommendations to Congress.

 

Award: H133S050134 ID: 238,   01-Oct-05 to 30-Sep-07
Grant Title: Phase II: Development of a Lightweight, Adjustable, Modular Pediatric Wheelchair
Host Institution/Grantee Name: Three Rivers Holdings, LLC
Principal Investigator: Willems, Chris
Program Mechanism: Small Business Innovation Research
Funding per year: FY05 $287,208; FY06 $212,773

Accomplishment. A new prototype was created that met critical design criteria of a commercial ready Pediatric Adjustable Lightweight Modular (PALM) Wheelchair. Design criteria met by the new PALM prototype were: 1) Improved ease and simplicity of the folding mechanism through the use of a forward folding mechanism. 2) Reduced weight through the use of injection molded components and design optimization. Approximately 5 pounds were removed by using injection molded parts instead of solid machined Delrin parts. 3) Improved functionality and ease of use through added features and components including: Removable leg rests, a greater range of tilt (55 degrees total) in the seat, an adjustable length split seat pan, side guards and ergonomic push handles, adjustable angle armrests, and quick release casters. 4) Improved aesthetic look through streamlined the injection molded parts, use of color, and the creation of a "visual language" amongst all the wheelchair's components. Tumbled components also improved surface finishes along with anodized all aluminum components, and powder coated tubes and steel components. 5) Streamlined cost-effective manufacturing through the use of OEM parts to replace some parts previously custom made. These parts include fasteners, seating components, wheels and caster fork.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. As a versatile, affordable tilt-in-space pediatric wheelchair, the PALM will fill a critical need not currently met by existing pediatric wheelchairs. Because the PALM is designed to grow with the child and promote independence, we expect that, rather than acting as a barrier (as a poorly fitted chair may become), the PALM will encourage exploration and facilitate cognitive development in the child. Importantly, the more affordable, highly adjustable, modular design of the PALM will not only benefit end-users, but will also be very useful in rehabilitation hospitals where depot-style wheelchairs are most commonly used. A low-cost, highly adjustable alternative could become a practical and affordable option for hospitals. Using a highly adjustable pediatric wheelchair in the hospital would make in-patient treatment and the transition to out-patient care more healthy and comfortable. The PALM incorporates a set of truly novel design concepts that enable it to uniquely meet the complex needs of a growing child. First, the PALM's primary construction consists of plastic components and straight tubes. This allows it to be easily customized on site and decreases cost by being inexpensively manufactured and shipped. Second, the tilt-in-space mechanism utilizes a unique four-bar linkage design that decreases the need for small moving parts such as rollers and spring loaded mechanisms such as those used in other tilt-in-space center-of-gravity chairs. Third, the PALM's modular design allows for great flexibility in the configuration of the wheelchair and adaptation to different sized bodies. Fourth, the PALM is highly adjustable and selectable: The seat depth, seat width, back rest height, back rest angle, leg rest angle, footrest angle, seat-to-floor height, and axle position are all adjustable. Finally, the PALM also converts from an attendant-style wheelchair to a self-propelled wheelchair. These features create a constellation of characteristics that clearly distinguishes the PALM from any other currently available pediatric wheelchair. The design and development efforts during this reporting period not only enabled the meeting of additional design criteria of a commercial ready PALM prototype, but also led to the identification of low-cost manufacturing methods and materials. This highlights perhaps the most valuable innovation of the PALM: Its ability to be both extraordinarily versatile and compelling cost-effective at the same time. This will help to insure what we hope will be an "outcome accomplishment nugget" of this project: A tilt-in-space pediatric adjustable, lightweight, modular, ergonomic, easy to use, comfortable, and durable wheelchair that will also be affordable so that it will obtainable by the widest possible audience here in the US and overseas. The earliest evidence of the success of these efforts is a RESNA paper presented in 2005 (during Phase I of this project). That paper (Zipfel E, Cooper RA, Pearlman J, McCartney M, Puhlman J, Design and Development of a New Tilt-in-Space Pediatric Wheelchair, Proceedings of the 28th Annual RESNA Conference, Atlanta, GA, CD-ROM, June 25-27, 2005), although not cited in this APR because it came out prior to the current cycle, documented the proof-of-concept of the PALM. More recently, at RESNA 2006 (cited in this APR), another paper was presented that reviewed focus group and ANSI/RESNA testing of the PALM prototype built in Phase I.

Documentation. Zipfel, E, Cooper, R, Boninger, D, Pearlman, J, & McCartney, M (2006). Testing and Evaluation of a Prototype Pediatric Wheelchair Design (Abstract Only).In B. Crane, Conference Chair (Ed.), 29th Annual RESNA Conference Proceedings. Atlanta, Georgia: RESNA.

Citation. Zipfel, E, Cooper, R, Boninger, D, Pearlman, J, & McCartney, M (2006). Testing and Evaluation of a Prototype Pediatric Wheelchair Design (Abstract Only).In B. Crane, Conference Chair (Ed.), 29th Annual RESNA Conference Proceedings. Atlanta, Georgia: RESNA.

Problem addressed. In the United States, there are over 4 million children (under the age of 18) with disabilities, and more than 10% of this population, or over 400,000 have physical disabilities that may require the use of a wheelchair (e.g., paralysis, Cerebral Palsy, or orthopedic impairments). Pediatric wheelchair users are distinct from their adult counterparts because they experience rapid physical growth and rapidly changing cognitive and functional skills. Children also find themselves in a variety of environments that in some cases may require dependant mobility systems (i.e., attendant-style wheelchairs pushed by others), while other cases may allow the child, if he or she is able, to self-propel their own wheelchair - an independence that is important to encourage in a growing child. Finally, pediatric seating and positioning must simultaneously address social and environmental demands unique to children while also minimizing the risk of common secondary injuries (e.g., pressure ulcers). The unique needs of pediatric wheelchair users have been significantly underserved. Although adult manual wheelchairs have improved dramatically over the past two decades, cost-effective innovations designed specifically for the pediatric population have been lacking. This is, at least in part, because research and development efforts have focused much more on adults than they have on children. The "output accomplishment nugget" described here directly addresses this need/gap through the successful development of the PALM prototype, a manual pediatric wheelchair specifically designed to meet the complex needs of a growing child.

Basis for accomplishment. Phase I and early Phase II work. The "immediate past cycle" entry below (under "Timeframe of Accomplishment") refers to work conducted during Phase I.

Award: H133B031127 ID: 245, 01-Oct-03 to 30-Sep-08
Grant Title: RRTC on Technology Promoting Integration for Stroke Survivors: Overcoming Societal Barriers
Host Institution/Grantee Name: Rehabilitation Institute Research Corporation
Principal Investigator: Roth, Elliot
Program Mechanism: Rehabilitation Research and Training Center
Funding per year: $800,000

Accomplishment. As a result of a peer-reviewed paper, the knowledge base of ambulation training of individuals post-stroke was advanced.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. As a research activity, a limb loading device was developed and used as an exercise intervention to improve walking function in individuals acutely post-stroke. Non-ambulatory acute stroke patients showed statistically significant improvements in limb loading capability; and ambulatory acute stroke patients showed statistically significant improvements in gait velocity. The effectiveness of this method of therapy and of this device was published in the peer-reviewed journal, Physical Therapy (Limb-loaded cycling program for locomotor intervention following stroke, Physical Therapy. 2005. 85(2);158-168. This new device and protocol was shown to be useful as an adjunct to conventional physical therapy. The device is safe and effective for improving walking function in individuals post-stroke. Biodex Medical Systems, Inc. has produced a modified version of the experimental apparatus and sold the device in the US and Japan as the Cyclocentrics Semi-recumbent Ergometer. The product has been temporarily taken off the market to undergo refinements in the design. Testing and development of this device also lead to the development of an intervention protocol, Limb-loaded pedaling, that was used in two randomized clinical trials. For more information on this see the PTClinResNet website for information about the clinical trails, STEPS and PEDALS (http://pt.usc.edu/clinresnet/). The Principal Investigator of the RRTC project that developed and tested the bicycle ergometer, David A. Brown, PhD, PT, is also the lead investigator of the phase III multi-site RCT STEPS project (Strength-Training Effectiveness Post-Stroke). This project is currently in progress.

Documentation. Information on the peer-reviewed publication can be found at - www.ptjournal.org. Information on the STEPS trial can be found at http://pt.usc.edu/clinresnet/.

Citation. Brown DA. Nagpal S. Chi S. Limb-loaded cycling program for locomotor intervention following stroke. Physical Therapy. 85(2):159-68, 2005.

Problem addressed. Functional training of people who have severely limited ambulatory skills (eg, those with a Functional Independence Measure [FIM] score of 1) is often a time-consuming task, which requires extensive assistance because these individuals may be unsafe in gait activities. Effective interventions for gait training during the early stages following stroke are scarce. For example, although body-weight-supported treadmill training has been shown to improve the walking function of people with hemiplegia, few adjunctive exercises exist that can complement the force-generating capability training and lower-limb patterning that is practiced during body-weight-supported treadmill training. For many people in the early stages following stroke, cyclical leg exercise is a safe, task-oriented locomotor intervention that is used to supplement functional ambulation training. The kinematic patterns of both locomotor tasks are similar. Both locomotor tasks are cyclical; require reciprocal flexion and extension movements of hip, knee, and ankle; and have alternating muscle activation of antagonists in a well-timed and coordinated manner. Because many characteristics of cyclical leg exercise are similar to those of walking, cyclical leg exercise can potentially play a valuable role as an adjunctive form of locomotor intervention for people with ambulatory dysfunction in the acute rehabilitation setting.

Award: H133A020505 ID: 291,   01-Oct-02 to 30-Sep-07
Grant Title: Moss Traumatic Brain Injury Model System
Host Institution/Grantee Name: Albert Einstein Healthcare Network
Principal Investigator: Hart, Tessa
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. The PI co-edited a special issue of Journal of Head Trauma Rehabilitation on impaired self-awareness in TBI, containing 6 new articles reflecting the state of the art and science in that topic area. The target audience for this product is TBI clinicians and researchers from multiple disciplines.
Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. Impaired self-awareness remains an aspect of TBI that is both scientifically puzzling and clinically important. The accomplishment brings the issue to the forefront of attention of both clinicians and researchers, describes the state of the science, and proposes many new avenues for further research. The Special Issue containing this compilation was published as the July-August 2005 issue of the Journal of Head Trauma Rehabilitation. Drs. Hart and Sherer have both received NIDRR funding to study this phenomenon in their TBIMS grants and in a separately funded collaborative project grant (1998-2002).

Documentation. Journal of Head Trauma Rehabilitation (whole issue) v 20, no. 4 published in 2005 by Lippincott Williams and Wilkins. Preface by Dr. Hart and Dr. Sherer (co-editors) followed by articles first-authored by Drs. Sherer, Sawchyn, Ownsworth, Hart, Garmoe, and Prigatano. The intended impact of this issue is to stimulate research and improve clinical knowledge of an important problem with indirect effects on the health and function of many people with TBI, impaired self-awareness.

Citation. Hart T, Sherer M (eds). Disorders of self-awareness. Journal of Head Trauma Rehabilitation, 20:4, 2005. (whole issue)

Problem addressed. Impaired self-awareness is an important clinical problem that is as yet not fully understood. Impaired self-awareness hampers communication between clinicians and people with TBI and leads to rehabilitation drop-out and failure. Communication within the family affected by TBI is also affected. There is a great need to better understand this phenomenon and to develop treatments for it. The nominated output seeks to further our knowledge in this area.

Basis for accomplishment. Studies on impaired self-awareness funded by NIDRR in grants to Drs. Hart and Sherer in 1998 and beyond. Some of these include: Sherer M, Hart T, Nick T: Measurement of impaired self-awareness after traumatic brain injury: A comparison of the Patient Competency Rating Scale and the Awareness Questionnaire. Brain Injury 17:25-37, 2003 Hart T, Whyte J, Polansky M, Millis S, Hammond FM, Sherer M, Bushnik T, Hanks R, Kreutzer J: Concordance of patient and family report of neurobehavioral symptoms at 1 year post traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 84:204-213, 2003 Sherer M, Hart T, Nick TG, Whyte J, Thompson RK, Yablon SA: Early impaired self-awareness after traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 84:168-176, 2003 Hart T, Sherer M, Whyte J, Polansky M, Novack T. Awareness of behavioral, cognitive and physical deficits in acute traumatic brain injury. Archives of Physical Medicine and Rehabilitation, 85:1450-1456, 2004 Sherer M, Hart T, Whyte J, Nick TG, Yablon SA. Neuro-anatomic basis of impaired self-awareness after traumatic brain injury: Findings from early computed tomography. Journal of Head Trauma Rehabilitation, 20:287-300, 2005. Hart T, Whyte J, Kim J, Vaccaro M. Executive function and self-awareness of "real-world" behavior and attention deficits following traumatic brain injury. Journal of Head Trauma Rehabilitation, 20:333-347, 2005.

Award: H133B031118 ID: 318,   01-Dec-03 to 30-Nov-08
Grant Title: RRTC in NMD-Enhancing Health, Function & Quality of Life
Host Institution/Grantee Name: Regents of the University of California, Davis
Principal Investigator: McDonald, Craig
Program Mechanism: Rehabilitation Research and Training Center
Funding per year: $800,000

Accomplishment. Developed practice guidelines. As a member of the subcommittee, the PI developed and published a new practice guideline regarding the use of corticosteroids for the treatment of individuals with Duchenne muscular dystrophy (DMD). These practice guidelines are a significant output that advances the knowledge regarding treatment of DMD. Dr. Craig McDonald, the Principal Investigator of the RRTC in Neuromuscular Diseases, was a member of the Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society that developed and authored the practice parameter (see citations and link below). The Medical Director of the Muscular Dystrophy Association (MDA) has recently said that this guideline has made significant changes in their practice, and as a result, many more physicians are prescribing corticosteroids for the treatment of muscular dystrophy making it a significant intermediate-term outcome. However, the genesis of the research that led to the development of this Practice Parameter by the AAN regarding the use of corticosteroids in patients with DMD started out as basic research performed by our RRTC/NMD beginning in 1983. From 1983 to 1993 the NIDRR-funded RRTC in NMD at UC Davis conducted a large-scale drug evaluation screen to evaluate the effects of pharmacological compounds in the dystrophic chicken, which is functionally, and histopathologically similar to DMD. Over 1,000 compounds were screened with this large capacity drug evaluation system. (Abresch, RT et al . Fed Proc 44, 505. 1985). As part of a NIDDR-funded activity, our group was the first to report that steroids significantly ameliorated some of the functional defects in an animal model of muscular dystrophy (Entrikin RK et al, 1984; 7: 130-136). Our study, which was carried out by the RRTC in Neuromuscular Disease, was cited as one the main reasons for testing prednisone in the first double-blind clinical trials of prednisone in boys with Duchenne muscular dystrophy (Brooke MH et al, Arch. Neurol. 44:812-817; 1987). Since we knew that corticosteroids have significant side effects, we examined whether it was the glucolcorticoid activity or mineralocorticoid activity that improved the function and histopathology seen in avian dystrophy. We showed that pure glucocorticoids were responsible for the improvements seen in avian dystrophy (Entrikin et al. FASEB J. 2:2722-2725, 1988). In 2000 McDonald and Carter reported that prednisone, when given at three years of age improved function of a boy with DMD (Carter GT, McDonald CM. Am J Phys Med Rehabil 2000; 79: 455-458). This work was also cited in the practice guidelines developed by Moxley et al (2005). Most all of these peer-reviewed articles cited above acknowledged NIDDR as one of the granting agencies that funded the work. During the current funding cycle, Dr. McDonald, the Principal Investigator of the RRTC in Neuromuscular Diseases, was a member of the American Academy of Neurology committee that reviewed the literature and published the practice guideline regarding the use of corticosteroids in DMD. In the practice guideline, the authors thoroughly examined the benefits and weaknesses of corticosteroid administration in patients with DMD and developed specific recommendations.

Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. The Practice Standards subcommittee of the American Academy of Neurology (AAN) issued a Practice Parameter that reported that corticosteroids (prednisone and deflazacort) are beneficial in the treatment of DMD, despite their significant side effects. Dr. McDonald, the Principal Investigator of the RRTC in Neuromuscular Diseases, was chosen to be a member of this AAN committee based upon the work that has been published based on NIDDR-funded activities and was an author who contributed significantly to the practice parameter. This practice parameter was developed, in part, through a culmination of research that investigators from the RRTC/NMD have conducted over the past 25 years. In 1985 we presented a poster that showed that corticosteroids were effective in ameliorating weakness in an animal model of muscular dystrophy. As a result of that work, the MDA funded the CIDD to conduct a randomized controlled trial (RCT) using prednisone, a corticosteroid, in patients with DMD. Since then, several more RCTs and case studies using prednisone have been published. In fact, the Cochrane Collaborative recently reported that corticosteroids are the only effective treatment to ameliorate the loss of strength in DMD. Nevertheless, due to the adverse side effects associated with corticosteroids, their acceptance and use by treating physicians has varied widely. In the practice guideline, the authors thoroughly examined the benefits and weaknesses of corticosteroid administration in patients with DMD and developed specific recommendations. Although these practice guidelines were first published during the previous reporting period (January 2005), during this reporting period, these practice guidelines have been presented to clinicians at several national events. These include the Muscular Dystrophy Association Clinic Directors Conference (Tucson, AZ 11/17/05), the Academy of Neurology Educational Session on Neuromuscular Diseases (4/5/06), University of Washington Review Course in Physical Medicine and Rehabilitation (4/7/06), and Oregon Health Science University Update on Neuromuscular Disease Conference during the reporting period. In summary, the AAN practice parameter concluded that prednisone and deflazacort are beneficial in the treatment of DMD. Seven high-quality studies were reviewed and showed that corticosteroid treatment resulted in a significant increase in strength, timed muscle function (such as time to climb stairs) and pulmonary function. The subcommittee determined that: 1. Effective treatments are: 0.75 milligrams per kilogram of body weight per day for prednisone, or 0.9 milligrams per kilogram per day for deflazacort. 2. The most frequent side effects are weight gain and the development of a Cushingoid facial appearance (rounded, puffy face). 3. There are insufficient data comparing prednisone and deflazacort to determine whether deflazacort has fewer side effects.

Documentation. The following are samples of articles citing the Practice Guideline by Moxley RT, Ashwal S, Pandya S, Connolly A, Florence J, Mathews K, Baumbach L, McDonald C, Sussman M, Wade C; (2005): K. A. Kleopa, A. Drousiotou, E. Mavrikiou, A. Ormiston, and T. Kyriakides. Naturally occurring utrophin correlates with disease severity in Duchenne muscular dystrophy. Hum. Mol. Genet., May 15, 2006; 15(10): 1623 - 1628. The URL for this citing article is: http://hmg.oxfordjournals.org/cgi/content/abstract/15/10/1623
W. D. Biggar, Duchenne Muscular Dystrophy. Pediatr. Rev., March 1, 2006; 27(3): 83 - 88. Corticosteroid Treatment and Functional Improvement in Duchenne Muscular Dystrophy: Long-Term Effect. American Journal of Physical Medicine & Rehabilitation. 84(11):843-850, November 2005. The URL for this citing article is: http://pedsinreview.aappublications.org/cgi/content/full/27/3/83
The following are samples of web sites citing the Practice Guideline by Moxley RT, Ashwal S, Pandya S, Connolly A, Florence J, Mathews K, Baumbach L, McDonald C, Sussman M, Wade C; (2005): www.guideline.gov/summary/summary.aspx?ss=15&doc_id=6310&nbr=4041
www.aan.com/press/press/index.cfm?fuseaction=release.view&release=242
www.aan.com/professionals/practice/pdfs/DMD_Guideline_Patients.pdf http://rarediseases.about.com/b/a/150502.htm

Citation. Moxley RT, Ashwal S, Pandya S, Connolly A, Florence J, Mathews K, Baumbach L, McDonald C, Sussman M, Wade C; Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society. Practice parameter: corticosteroid treatment of Duchenne dystrophy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2005 Jan 11;64(1):13-20.

Web site: www.neurology.org/cgi/content/full/64/1/13

Problem addressed. Duchenne muscular dystrophy (DMD) is the most common and devastating type of muscular dystrophy (incidence 1 in 3500 live born males worldwide). DMD is characterized by a complete loss of dystrophin, leading to progressive muscle weakness and wasting. DMD patients typically become wheelchair-bound at the age of 10-12 and succumb to respiratory failure in their late teens-early twenties due to involvement of the diaphragm and other respiratory muscles. Despite the significant number of animal studies and clinical trials that have been performed to reduce the progression of DMD, no pharmacological treatments have been accepted to improve the function of individuals with DMD until recently. Over twenty years ago our NIDDR-funded RRTC conducted the first double-blinded randomized controlled trials (RCTs) in animals to evaluate the effects of pharmacological compounds for the treatment of DMD. These studies were followed by several well-conducted RCTs in humans with DMD. However, due to the significant number of side effects and the lack of long-term data, until recently, no drug treatments have been advocated as a standard of practice for Duchenne muscular dystrophy. Members of the Quality Standards Subcommittee of the American Academy of Neurology; Practice Committee of the Child Neurology Society subcommittee reviewed all available research for the use of corticosteroids in the treatment of Duchenne muscular dystrophy. Corticosteroids are man-made drugs that are similar to the body's hormone cortisone. Two corticosteroids, prednisone and deflazacort, were found to slow the rate of muscle deterioration, and are recommended as potential treatments to minimize the effect of Duchenne muscular dystrophy. Prednisone was found to help muscle strength and function and should be offered as a treatment option. Deflazacort, a drug similar to prednisone, is also recommended as a treatment option. These corticosteroids were shown to increase ambulatory activity in boys for more than two years. Further work needs to be conducted to determine the long-term benefits and risks of these corticosteroids. The authors of the practice guideline caution that an offer of treatment with corticosteroids should include a balanced discussion of potential benefits and risks. Possible side effects of corticosteroid therapy should be closely monitored by a physician. Other treatments for Duchenne muscular dystrophy include physical therapy to reduce muscle tightening, orthopedic support devices, and corrective orthopedic surgery to improve the ability to function.

Basis for accomplishment. From 1983 to 1993 the NIDRR-funded RRTC in NMD at UC Davis conducted a large-scale drug evaluation screen to evaluate the effects of pharmacological compounds in the dystrophic chicken, which is functionally, and histopathologically similar to DMD. Over 1,000 compounds were screened with this large capacity drug evaluation system. (Abresch, RT et al . Fed Proc 44, 505. 1985). As part of a NIDDR-funded activity, our group was the first to report that steroids significantly ameliorated some of the functional defects in an animal model of muscular dystrophy (Entrikin RK et al, 1984; 7: 130-136). Our study, which was carried out by the RRTC in Neuromuscular Disease, was cited as one the main reasons for testing prednisone in the first double-blind clinical trials of prednisone in boys with Duchenne muscular dystrophy (Brooke MH et al, Arch. Neurol. 44:812-817; 1987). Since we knew that corticosteroids have significant side effects, we examined whether it was the glucolcorticoid activity or mineralocorticoid activity that improved the function and histopathology seen in avian dystrophy. We showed that pure glucocorticoids were responsible for the improvements seen in avian dystrophy (Entrikin et al. FASEB J. 2:2722-2725, 1988). When the mdx mouse was found to be missing dystrophin, the same protein that is missing in Duchenne muscular dystrophy, we began characterizing its functional and contractile properties (Wineinger MA et al. Muscle Nerve 1998; 21: 1075-1077; Wineinger MA et al; Am J Phys Med Rehabil 1998; 77: 20-27). In vitro contractile studies on the extensor digitorum longus muscle of the mdx mouse conducted by our laboratory showed that treatment of the mouse with dexamethasone, a pure glucocorticoid, significantly increased the tetanic tension per muscle weight and significantly reduced its rate of fatigue. In 1995 our group published a series of peer-reviewed articles entitled the "Profiles of Neuromuscular Diseases Supplement," published as a supplement in the American Journal of Physical Medicine & Rehabilitation (McDonald CM et al, 1995). This longitudinal investigation utilized a variety of impairment measures, such as strength, quantitative strength, contractures, activity limitations such as timed motor performance, functional grade and cognitive outcomes. The findings from this long-term study revealed that manual muscle test measurements showed loss of strength in a linear fashion from ages 5-13 years. Several authors have used this data to develop guidelines for the management of neuromuscular diseases. In 2000 McDonald and Carter reported that prednisone, when given at three years of age improved function of a boy with DMD (Carter GT, McDonald CM. Am J Phys Med Rehabil 2000; 79: 455-458). This work was also cited in the practice guidelines developed by Moxley et al (2005). Most all of these peer-reviewed articles cited above acknowledged NIDDR as one of the granting agencies that funded the work. During the current funding cycle, Dr. McDonald, the Principal Investigator of the RRTC in Neuromuscular Diseases, was a member of the American Academy of Neurology committee that reviewed the literature and published the practice guideline regarding the use of corticosteroids in DMD. In the practice guideline, the authors thoroughly examined the benefits and weaknesses of corticosteroid administration in patients with DMD and developed specific recommendations.

Award: H133B031118 ID: 320,   01-Dec-03 to 30-Nov-08
Grant Title: RRTC in NMD-Enhancing Health, Function & Quality of Life
Host Institution/Grantee Name: Regents of the University of California, Davis
Principal Investigator: McDonald, Craig
Program Mechanism: Rehabilitation Research and Training Center
Funding per year: $800,000

Accomplishment. Advanced knowledge regarding obesity, physical activity, and metabolic syndrome in NMD. During the project period the investigators from the RRTC/NMD performed research to advance our knowledge and get a much more accurate picture regarding the effects of obesity, physical activity, and metabolic syndrome in individuals with neuromuscular diseases (NMDs). Before this research began, very little was known about the rate of metabolic syndrome in patients with NMDs. We have shown that individuals with NMDs have a much higher amount of obesity and metabolic syndrome than the able-bodied population, and that these factors will predispose individuals with NMDs to cardiovascular disease and type 2 diabetes. We have also shown that the most common indexes of obesity (overweight and high body mass index) are not adequate in NMDs because they have abnormally low amounts of muscle mass. Most of the publications that contributed to this review were peer-reviewed publications that were conducted by the RRTC in NMD and have acknowledged NIDRR for funding these studies. Most of this work was published in a journal article that reviewed the importance of prevention and identification of diseases associated with physical activity and obesity in neuromuscular diseases (see citation and links below). Once we had shown that lack of physical activity and obesity contribute to metabolic syndrome in individuals with NMDs, we examined the effects of a simple home-based intervention prescription to prevent the problems associated with obesity and low physical activity in these disabled populations. This study, which was published in a peer-reviewed journal and acknowledged NIDRR for funding the work, showed that a very modest activity prescription (increase the amount of steps taken per day by 25%) and a simple dietary prescription produced modest improvements in physical activity, caloric intake, and body fat percentages in individuals with NMDs. Information from these two papers is targeted toward physicians who care for NMD patients and who are the ones who will put the findings into practice that will reach the patient.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence.Our center has conducted a series of studies regarding the effects of obesity, physical activity, metabolic syndrome and the effects of dietary and physical interventions in individuals with neuromuscular diseases. A compendium of this work was published by one of our investigators in an invited review article during the current reporting period. Most of the work cited in the review was performed by the RRTC in NMD and was funded by NIDRR. This review showed that there is a growing recognition that individuals with NMDs are at greater risk than the general population for metabolic syndrome, cardiovascular disease, type 2 diabetes, and obesity. Individuals with NMDs have significantly increased percent body fat and total fat mass when compared to an able-bodied group, despite having no differences in body mass index (BMI). Individuals with NMDs also have reduced physical activity and lower total energy expenditure than a control group. Adiposity was associated with the lower level of physical activity. These individuals also showed several symptoms of metabolic syndrome including low high-density lipoprotein and cholesterol, high levels of blood glucose and triglycerides, and increased blood pressure. Several of our studies have shown that, despite having a neuromuscular disease, exercise can be beneficial to individuals with NMDs. Prevention and treatment of these secondary diseases, which are associated with a sedentary lifestyle, are often more challenging than in the able-bodied population. Despite these difficulties, we performed a case-controlled clinical trial to determine whether a home-based activity and dietary intervention can increase activity level, reduce caloric intake, and impact positively components of metabolic syndrome in a disabled population. This study showed that a very modest activity prescription (increase the amount of steps taken per day by 25%) and a simple dietary prescription produced modest improvements in physical activity, caloric intake, and body fat percentages in individuals with NMDs. Although this 6-month program found positive changes, it did not affect risk factors associated with metabolic syndrome. It remains to be seen if a program longer than 6 months or a more rigorous program could lead to a reduction in the risk factors associated with metabolic syndrome. Although this study was initiated during the previous grant period, the final subjects were tested, the final data analyzed and the publication prepared during the current grant period. The peer-reviewed journal article was published during current reporting period. The papers that were published this year add to this body of knowledge.

Documentation. The following papers are example of authors who have cited work by the RRTC/NMD on physical activity, obesity, and metabolic syndrome and provide evidence that the work of the RRTC/NMD has produced a significant short-term outcome:
Ansved, Tor. Muscular dystrophies: influence of physical conditioning on the disease evolution. Current Opinion in Clinical Nutrition & Metabolic Care. 6(4):435-439, July 2003.
Simmons, Zachary. Management Strategies for Patients With Amyotrophic Lateral Sclerosis From Diagnosis Through Death. Neurologist. 11(5):257-270, September 2005. Krivickas, Lisa S. Exercise in Neuromuscular Disease. Journal of Clinical Neuromuscular Disease. 5(1):29-39, September 2003. Karper WB., Stasik, SC. A Successful, Long-Term Exercise Program for Women With Fibromyalgia Syndrome and Chronic Fatigue and Immune Dysfunction Syndrome. Clinical Nurse Specialist. 17(5):243-248, September 2003.

Citation. The outputs from this accomplishment acknowledged NIDDR and were published in: Kilmer DD, Wright NC, Aitkens S. Impact of a home-based activity and dietary intervention in people with slowly progressive neuromuscular diseases. Arch Phys Med Rehabil. 2005 Nov;86(11):2150-6. Kilmer DD, Zhao HH. Obesity, Physical Activity, and the Metabolic Syndrome in Adult Neuromuscular Disease. Phys Med Rehabil Clinics N Amer. 2005;16(4):1053-1062. Other NIDRR-funded RRTC work in this area includes: McDonald CM et al. Arch Phys Med & Rehab 2005;86(802-808. Aitkens S et al. Arch Phys Med Rehabil. 2005;86(5):1030-6. Liusuwan A et al.. J Spinal Cord Med.2004;27:S24-8. Kilmer DD. Am J Phys Med Rehabil 2002:81:S121-S126. Kilmer DD. Am J Phys Med Rehabil 2002;8:S148-S150. Fowler WM Jr, Frontera WR. Am J Phys Med Rehabil 2002; 81(11):S187. Kilmer DD et al. Muscle Nerve 24(9):1181-7, 2001. Kilmer DD. Phys Med Rehabil Clinics N Amer 9(1): 115-125, 1998. McCrory MA et al. Phys Med Rehabil Clinics N Amer 9(1): 127-143, 1998. McCrory MA et al. Am J Clin Nutr 67(6): 1162-1169, 1998. Wright NC et al. Arch Phys Med Rehabil 77(1): 64-69, 1996.

Web site: www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16271563&itool=iconabstr&query_hl=2&itool=pubmed_docsum

Problem addressed. As the lifespan of many people with chronic physical disabilities approaches that of the able-bodied, it becomes increasingly important to minimize diseases associated with a long-term sedentary lifestyle. Physical inactivity and obesity are clearly associated with type II diabetes mellitus, coronary artery disease, and metabolic disease. These secondary conditions play an important role in reducing quality of life. Until definitive treatment for the primary disease of nerve and muscle become available, improving the quality of life should be a major focus of treating patients with NMDs and other physical disabilities. The work that we have performed has documented issues regarding obesity, physical activity, and the risk of secondary conditions in individuals with NMDs. We have also show that exercise is feasible and that a simple home-based diet and physical activity intervention may be able to alter the sedentary lifestyle and prevent or slow down some of the secondary conditions. For some physical disabilities, increasing physical activity may be realistic, but for the more severely disabled, dietary intervention may be the principal method to reduce the incidence of these secondary conditions. Compared to the able-bodied, additional factors of limited financial resources, transportation, medical care, and environmental barriers will require a much greater level of creativity to formulate recommendations to improve the quality of life for people with disabilities.

Basis for accomplishment. The project activities were based on a case-controlled study designed to determine whether a home-based activity and dietary intervention can increase activity level, reduce caloric intake, and impact positively components of metabolic syndrome in a disabled population. The testing occurred at 3 points during the 6-month intervention period and at 6 months post-intervention. At each test point laboratory testing included measurement of anthropometric and metabolic variables and 3 days of home-based activity and dietary monitoring. A personally tailored activity and a simple one-time dietary prescription based on baseline testing were implemented during the 6-month intervention period. An individualized dietary prescription was provided focusing on problematic issues identified from the baseline dietary profile. The most common dietary recommendations were to reduce intake of high fat foods, increase fruit intake, increase water intake, reduce sugar intake, and increase foods rich in calcium. Using a pedometer, subjects were instructed to increase number of steps by 25% over their baseline determined from home monitoring. At the end of the protocol, mean step count increased approximately 27% above baseline and caloric intake decreased over 300kcal/d. Body fat percentage significantly decreased. Gait efficiency did not change, and metabolic variables did not show statistically significant improvement, although 2 of the 5 subjects originally meeting the criteria for metabolic syndrome at baseline no longer met the criteria at the end of the intervention period. Six months after completing the protocol, caloric intake remained significantly reduced, but although mean step count remained elevated, the increase was not statistically significant. The determination of the amount of physical activity, the risk of metabolic syndrome, and the body composition were determined through cross-sectional studies performed during the current and previous funding period. The initiation of the clinical trials that resulted in the original research publication cited in the accomplishment began in the previous funding cycle (1998-2003). Final subjects, statistical analysis, and preparation of the publication occurred during the current funding cycle (2003-2008).

Award: H133B031118 ID: 322,   01-Dec-03 to 30-Nov-08
Grant Title: RRTC in NMD-Enhancing Health, Function & Quality of Life
Host Institution/Grantee Name: Regents of the University of California, Davis
Principal Investigator: McDonald, Craig
Program Mechanism: Rehabilitation Research and Training Center
Funding per year: $800,000

Accomplishment. Pain in NMDs: Until we began our current work, the available literature on NMDs gave scant mention to pain as a component to these disorders. However, in our clinical experience, chronic pain seemed to be a serious overlooked problem for many persons with NMDs. To help determine the accuracy of this opinion based initially on clinical experience, investigators from the RRTC/NMD began a multi-center program of research that was initially (and still is) funded by NIDRR to study the nature and scope of chronic pain and its impact on functioning in patients with NMDs. During the current reporting period investigators from the RRTC/NMD published a peer-reviewed article that summarized our research on the nature and scope of chronic pain and its impact on daily functioning in patients with neuromuscular diseases (NMDs). This summary advances our knowledge regarding the degree and extent of pain in NMDs. This work provides strong evidence that chronic pain is a major problem for many persons with neuromuscular diseases (NMDs) and adds significantly to our understanding of the nature of pain in chronic NMDs. Information from these papers is targeted toward physicians who care for NMD patients as they are the ones who will put the findings into practice. NIDRR was acknowledged as one of the funding sources for the summary paper described above, as well as the individual publications included in the paper.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. During the current reporting period investigators from the RRTC/NMD published an invited review article that summarized our research on the nature and scope of chronic pain and its impact on daily functioning in patients with neuromuscular diseases (NMDs). This article provides strong evidence that chronic pain is a significant problem for many, but not all persons with NMD. The degree of pain has been found to vary in different studies and by NMD diagnoses. Less is known about specific details concerning the nature and impact of chronic pain, as well as effective treatments. This summary paper cites the following studies that were conducted as part of the NIDRR-funded Research and Training Center in Neuromuscular Disease: . Jensen MP, Abresch RT, Carter GT, and McDonald CM. Chronic pain in persons with neuromuscular disease. Arch Phys Med Rehabil 2005; 86:1155-1163. (This article acknowledged NIDRR funding). . Carter GT wt al. Modafinil to treat fatigue in amyotrophic lateral sclerosis: an open label pilot study. Am. J. Hosp. Palliat. Med., 2005, 22(1):55-59. (This article acknowledged NIDRR funding). . Jensen PM, Abresch RT, Carter GT. The reliability and validity of a self-report version of the FIM instrument in persons with neuromuscular disease and chronic pain, Arch Phys Med Rehabil. 2005;86:116-22). (This article acknowledged NIDRR funding). . Abresch RT, Carter GT, Jensen MP, Kilmer DD. Assessment of pain and health-related quality of life in slowly progressive neuromuscular disease. Am J Hosp Palliat Med 2002; 19(1):39-48. (This article acknowledged NIDRR funding). . Carter GT, Sullivan MD. Antidepressants in pain management. Curr Opin Investig Drugs 2002;3:454-458. . Carter GT, Galer BS. Advances in the management of neuropathic pain. Phys Med Rehabil Clin N Am 2001;12:447-459. (This article acknowledged NIDRR funding). Abresch RT, Jensen MP, Carter GT. Health-related quality of life in peripheral neuropathy. Phys Med Rehabil Clin N Am 2001;12:461-472. (This article acknowledged NIDRR funding). . Carter GT, Weydt P. Cannabis: old medicine with new promise for neurological disorders. Curr Opin Investig Drugs 2002;3:437-440. . Carter GT, Rosen BS. Marijuana in the management of amyotrophic lateral sclerosis. Am J Hosp Palliat Care 2001;18:264-270. . Carter GT, Jensen MP, Galer BS, Kraft GH, Crabtree LD, Beardsley BA, Abresch RT, Bird TD. Neuropathic pain in Charcot-Marie-Tooth disease. Arch Phys Med Rehabil 1998; 79:1560-1564. (This article acknowledged NIDRR funding).

Documentation. Ehde DM, Hanley MA. Pain in Patient Groups Frequently Treated by Physiatrists. Physical Medicine & Rehabilitation Clinics of North America. May 2006 (Vol. 17, Issue 2, Pages 275-285)
Engel JM, Kartin D, Jaffe KM. Exploring Chronic Pain in Youths with Duchenne Muscular Dystrophy: A Model for Pediatric Neuromuscular Disease. Physical Medicine and Rehabilitation Clinics of North America. November 2005 (Vol. 16, Issue 4, Pages 1113-1124)
Stojkovic T, de Seze J, Dubourg O, Arne-Bes MC, Tardieu S, Hache JC, Vermersch P. Autonomic and respiratory dysfunction in Charcot-Marie-Tooth disease due to Thr124Met mutation in the myelin protein zero gene. Clinical Neurophysiology. September 2003 (Vol. 114, Issue 9, Pages 1609-1614)
Galer BS, Henderson J, Perander J. Course of Symptoms and Quality of Life Measurement in Complex Regional Pain Syndrome: A Pilot Survey. Journal of Pain and Symptom Management. October 2000 (Vol. 20, Issue 4, Pages 286-292)

Citation. Hoffman AJ, Jensen MP, Abresch R T, Carter GT. Chronic Pain in Persons with Neuromuscular Disease. Physical Medicine and Rehabilitation Clinics of North America. November 2005 (Vol. 16, Issue 4, Pages 1099-1112)

Web site: www.pmr.theclinics.com/article/PIIS1047965105000689/abstract

Problem addressed. Pain has not historically been a focus of clinicians and researchers who study neuromuscular disease. The available literature on neuromuscular disease (NMD) gives scant mention to pain as a component of these disorders. However, in our clinical experience, chronic pain appears to be a serious problem for many persons with NMD. To help determine the accuracy of our opinions based initially on clinical experience, our group began a multi-center program of research to study the nature and scope of chronic pain and its impact on functioning in patients with NMD.

Basis for accomplishment. Investigators from the RRTC/NMD surveyed 617 patients with Charcot-Marie-Tooth (CMT) disease. Seventy-one percent of these CMT patients reported having pain, and these subjects were significantly younger than those reporting no pain. Chronic pain in this sample was described as 'dull' (15%) or 'burning' (8%), whereas intermittent or breakthrough pain was described as 'sharp' (18%), 'stabbing' (12%), 'burning' (3%), 'hot' (2%) or 'cold' (2%). The most frequent pain sites were low back (70%), knees (53%), ankles (50%), toes (46%), and feet (44%). The investigators from the RRTC/NMD also performed a survey that examined the health-related quality of life in 811 individuals with slowly progressive neuromuscular disease. A substantial number of these participants (54%) reported that their pain was moderate to very severe. Moreover, the frequency and severity of pain in this population was significantly greater than levels of pain reported by the general US population. In a recent study, investigators from the RRTC surveyed 193 individuals with NMD about their pain intensity, quality, interference, location, treatment, and general quality of life. Seventy-three percent of the sample reported pain, with 27% reporting severe pain. Pain was described most frequently as 'deep', 'tiring', 'sharp', and 'dull'. Pain interfered with daily activities the most in patients with myotonic muscular dystrophy, amyotrophic lateral sclerosis and the least in patients with CMT. The most frequent pain sites were back (49%), leg (47%), shoulder (43%), and neck (40%). Over the counter medications were used most often for pain relief (ibuprofen/aspirin 61%, acetaminophen 47%), followed by physical therapy (43%) and narcotic analgesics (35%). Respondents with severe pain (average pain >7 on 0-10 scale) reported using narcotics (50%), followed by ibuprofen/aspirin (47%) and acetaminophen (37%). Preliminary evidence suggests that pain sites might also vary as a function of NMD diagnosis. For example, the most common pain sites for patients with CMT were the low back, legs and feet which is consistent with the disease that affects the legs and feet sooner and more severely than other parts of the body. Patients with facioscapulohumeral dystrophy reported pain more often in their back and shoulders, which is consistent with the disease that usually encompasses severe lumbar lordosis and shoulder girdle insatiability. Finally, evidence suggests the possibility that pain can have a negative impact on functioning in persons with NMD. Abresch et al, found a significant correlation between increased pain and lower levels of general health, vitality, social function, and physical role in each of the NMD groups. They also found that sleep disturbance was a problem in 68% of their sample and was associated with pain. Jensen et al, found a greater impact of pain on mobility, normal work, enjoyment of life, and recreational activities. They also found that persons with NMD reported significantly greater dysfunction than normative populations, as measured by physical functioning, physical role, bodily pain, general health, vitality, and social functioning. Additional research is urgently needed to better understand NMD-related pain; especially the effective treatment of NMD-related pain. This research should ultimately contribute to an overall increase in well-being and a decrease in suffering among persons with NMD and chronic pain.

Award: H133G020029 ID: 332,   01-Sep-02 to 31-Aug-06
Grant Title: Empowering Persons with Spinal cord Injury Through a Shared Decision Making Program
Host Institution/Grantee Name: Case Western Reserve University
Principal Investigator: Murray, Patrick
Program Mechanism: Field Initiated Project
Funding per year: $149,759

Accomplishment. Developed a multi-media CD Rom decision support tool (Urine Control) about bladder management for persons with a spinal cord injury. This product relates to NIDRR's Long Range Plan which explicitly states the need to use information technologies to expand opportunities for informed choice in personal decision making.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The decision tool is tailored to an individual's level of injury through the input of the user answering specific questions about their level of injury and hand function. The Urine Control program goes through only those bladder management techniques that are appropriate for the individual's level and function. The Urine Control program first goes through social issues to take into account when considering a bladder management techniques (e.g. work situation, leisure activities, and sexuality), then the program describes how the bladder works in an non-injured person and what occurs to bladder function after injury. It then goes over the different bladder management techniques and outlines both the benefits and risks associated with every technique. At the end of the program, the user can print out a notebook that can help further with the decision process and be taken to clinic appoints to initiate discussions with the SCI physician about the different bladder management options. The evidence that this accomplishment matured in the current reporting period is the Urine Control CD ROM itself.

Documentation. The Urine Control Program is available by request through email: mroach@metrohealth.org. This link below is an example of the embedded link within Urine Control that allows users to obtain additional information on a variety of topics covered in the program. www.chrp.org/empowering/autonomic_dys.htm

Citation. M.J. Roach, P.K. Murray. A Shared Decision Aid for Bladder Management. 14th Interurban Spinal Cord Injury Annual Meeting, Kingston, Canada, September 2005.

Problem addressed. Appropriate bladder care is one of the most important clinical issues that the person with spinal cord injury must address. complications related to the urinary tract are one of the most costly aspects of long term care for persons with SCI. There is considerable geographic variation in the bladder management that physicians who care for persons with SCI recommend to their patients as well as considerable controversy about what the 'best' approach to bladder management is. As persons with SCI face decisions about how to manage their bladder, improved information that fits their circumstance is critical.

Basis for accomplishment. Project activities that were conducted that resulted in this accomplishment were: 2002-2003: 1) Development of Urine Control script. 2) Expert Panel participation in development of script. 3) Contract with Cleveland Institute of Art Media Department to produce CD ROM 4) Conduct focus groups with SCI consumers to determine the important social issues to consider when choosing a bladder management technique. 5) Incorporate suggestions from expert panel and consumers into the script. 6) Obtain final approval of script from expert panel. 7) Begin creating animations and determining photo that will be needed for the program. 8) Set up photo shoots. 2003-2004 1) Continue developing animations. 2) Conduct final photo shoots 3) Hire professional voices for program narrative 4) Record narrative 5) Finalize animations 6) Integrate animation, photos and narrative 7) Produce a prototype of final program 8) Show prototype to SCI consumers and clinicians to obtain feedback. 9) Edit final program incorporating feedback from consumers and clinicians. 2004-2005 1) Produce final program 2) Develop the programs associated web pages that are linked through the CD ROM. These web pages contain additional information on topics covered in the CD ROM and can be updated as new information about bladder management comes to light.

Award: H133A020103 ID: 333,   01-Oct-02 to 30-Sep-07
Grant Title: University of Washington Burn Injury Rehabilitation Model System
Host Institution/Grantee Name: University of Washington
Principal Investigator: Engrav, Loren
Program Mechanism: Model System
Funding per year: $300,000

Accomplishment. Development, initial validation and publication of the female, red Duroc pig model of hypertrophic scarring, funded under a previous NIDRR award, is now contributing to advances in knowledge regarding the etiology and potential treatment of this troublesome sequelae of burns as evidenced by the use of the model by other research centers and recent receipt of NIH funding to further validate and study the model.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. We have established that the Duroc model of scarring is similar to human scarring in clinical and histologic appearance; immunohistologic localization of TG§1, IGF-1, decorin, and versican; nitric oxide levels; counts of nerve fibers and mast cells; and the presence of collagen nodules (published in four NIDRR credited manuscripts cited below). No other proposed model has been this well validated. This model has now been used by two other research centers (see documentation below). Furthermore, the NIH has recently determined that this model is worthy of NIH funding (see documentation below). The documentation below demonstrates that the evidence matured during the current performance period.

Documentation. These manuscripts demonstrate that this animal model is now being used by other researchers, a change in scar research practice. Gallant-Bhem CL, Hart DA. Genetic analysis of skin wound healing and scarring in a porcine model. Wound Repair Regen. Jan-Feb 2006;14(1):46-54. Gallant-Behm CL, Olson ME, Hart DA. Cytokine and Growth Factor mRNA Expression Patterns Associated with the Hypercontracted, Hyperpigmented Healing Phenotype of Red Duroc Pigs: A Model of Abnormal Human Scar Development? J Cutan Med Surg. March 2, 2006. Gallant-Behm CL, Tsao H, Reno C, Olson ME, Hart DA. Skin Wound Healing in the First Generation (F1) Offspring of Yorkshire and red Duroc pigs: Evidence for Genetic Inheritance of Wound PhenoType.  Burns 2006;32(2):180-193. Liang Z, Xie CY, Lin HB, Guo ZD, Yang WG. [Pathomorphological Observation of the Hypertrophic Scar Induced by Injury to Conical Structure in Female, Red Duroc Pig]. Zhonghua Shao Shang Za Zhi 2006;22(1):29-32. Evidence of the NIH funding may be found by searching the NIH database located at http://crisp.cit.nih.gov/ for "Engrav".

Citation. Zhu, KQ, Engrav, LH, Armendariz, R, Muangman, P, Klein, MB, Carrougher GJ, Deubner, H, Gibran, NS. Changes in VEGF and nitric oxide after deep dermal injury in the female red duroc pig - further similarities between female duroc scar and human hypertrophic scar. Burns 31(1):5-10, 2005.
Zhu, KQ, Engrav, LH, Tamura RN, Cole, JA, Muangman, P, Carrougher, GJ, Gibran, NS. Further similarities between cutaneous scarring in the female, red Duroc pig and human hypertrophic scarring. Burns 30(6):518-30, 2004.
Liang, Z, Engrav, LH, Muangman, P, Muffley, LA, Zhu, KQ, Carrougher, GJ, Underwood, RA, Gibran, NS. Nerve quantification in female red Duroc pig (FRDP) scar compared to human hypertrophic scar. Burns 30(1):57-64, 2004.
Zhu, KQ, Engrav, LH, Gibran, NS, Cole, JK, Matsumura, H, Piepkorn, M, Isik, FF, Carrougher, GJ, Muangman, PM, Yunusov, MY, Yang, TM. The female, red Duroc pig as an animal model of hypertrophic scarring and the potential role of the cones of skin. Burns 29(7):649-64, 2003.

Problem addressed. Raised, thickened ugly scars that develop following burns seriously interfere with physical function, psychological recovery, return to work and school, and community re-entry. In fact, they may be the single most troublesome sequelae of burns. Our understanding of etiology and treatment is essentially nil. In fact, no significant change in treatment has occurred in the past three decades. Although there are several reasons for this pitiful situation, a very significant reason is the lack of an accepted, useful animal model. Several have been proposed over the decades, but none have achieved wide acceptance and use since all have significant scientific flaws. Without an animal model, the only way to study this process is with human tissues, which are extremely difficult to obtain in a systematic fashion. The adoption of the Duroc model and the funding of the Duroc model are aimed at the scientists involved in scar research who now have a laboratory method to study the problem.

Basis for accomplishment. A New Approach to the Etiology of Hypertrophic Scarring. The general aim for this project was to develop an increased understanding of hypertrophic scarring. To accomplish this objective, this project focused on confirming (specific aim 1) that scarring in the red Duroc pig is similar to human hypertrophic scar. Our peer-reviewed published reports during the course of this funding cycle (but previous to this reporting period), demonstrate that we have achieved this aim and that it has been recognized by other, non-University of Washington researchers.)

Award: H133N000029 ID: 354,   01-Sep-00 to 31-Aug-06
Grant Title: Special Projects and Demonstrations for Spinal Cord Injury
Host Institution/Grantee Name: Los Amigos Research and Education Institute, Inc.
Principal Investigator: Waters, Robert
Program Mechanism: Model System
Funding per year: $345,000

Accomplishment. During the 1985 through 1995 cycles of Model SCI System funding, we conducted research on upper extremity problems in individual with SCI and produced a number of related peer-reviewed publications. The most prominent being: Sie, I., Waters, R., Adkins, R.H., and Gellman, H.: Upper Extremity Pain in the Post-Rehabilitation Spinal Cord Injured Patient. Archives of Physical Medicine and Rehabilitation 73(1):44-48, 1992.

Type. short-term outcome (advances in knowledge)

Description of accomplishment and supporting evidence. We believe the publication was the first to recognizing a significant problem for individuals living with SCI and prompted lines research at a number of different institutions. This publication has been cited 88 times; 9 times during the current reporting period.

Documentation. http://scholar.google.com/scholar?as_q=Upper+Extremity+Pain+&num=100&btnG=Search+Scholar&as_epq=&as_oq=&as_eq=&as_occt=title&as_sauthors=Sie&as_publication=&as_ylo=1992&as_yhi=1993&as_allsubj=all&hl=en&lr=

Citation. 88 citations; 9 during current reporting period.

Web site: http://scholar.google.com

Problem addressed. upper extremity problem in individuals with SCI.

Award: H133A020518 ID: 408,   01-Oct-02 to 30-Sep-07
Grant Title: JFK-Johnson Rehabilitation Institute TBI Model System
Host Institution/Grantee Name: JFK Johnson Rehabilitation Institute
Principal Investigator: Cicerone, Keith
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. Developed a revised version of the Coma Recovery Scale (CRS-R)- a standardized assessment instrument designed to evaluate and monitor neurobehavioral function in patients with disorders of consciousness. Published data from two recent studies suggest that the CRS-R improves differential diagnosis among patients with disorders of consciousness and is useful in monitoring long-term functional outcome. The target audience for this accomplishment is clinicians and researchers working with patients with disorders of consciousness, i.e. vegetative and minimally conscious states.

Type. intermediate outcome (changes in policy, practice, behavior or systems capacity)

Description of accomplishment and supporting evidence. Since publication of the 2004 paper, the CRS-R has been requested by researchers and clinicians throughout the U.S., Europe, Asia, South America and Australia. PDF copies of the CRS-R are forwarded electronically when requested. Evidence that the CRS-R is relevant to an external audience is provided by the fact that the CRS-R has been adopted for use in government-funded epidemiologic studies of VS and MCS in Belgium and Italy. Preliminary results of the Italian "GISCAR" study of the incidence, prevalence and costs of care in patients in VS and MCS were reported at a national conference held in Reggio Emilia, Italy on March 23-25, 2006. Diagnostic data for this study were obtained using the CRS-R. The Belgian government, through the Belgian Federal Department of Health, Food Chain Saftey and Environment, is using the CRS-R to collect epidemiologic data on VS and MCS. A national meeting held in Brussels on 11/30/05 released data on incidence and outcome in VS and MCS after one year of surveillance. 3) A PubMed search found two recently-published studies demonstrating use of the CRS-R in TBI outcomes research.

Documentation. Coma Recovery Scale-Revised: www.njrehab.org/tbims/ComaRecoveryScale.pdf
Belgian Federal Expert Platform: (delphine.simoens@health.fgov.be) Reggio Emilia Local Health Unit Training and Communication Offices: (Francesco.Lombardi@ausl.re.it)

Citation. Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale- Revised: Measurement Characteristics and Diagnostic Utility. Archives of Physical Medicine and Rehabilitation, 2004;85(12):2020-2029. (doi:10.1016/j.apmr.2004.02.033)

Web site: www.njrehab.org/tbims/ComaRecoveryScaleArticle.pdf

Problem addressed. At present, there is no definitive test for consciousness. The determination of whether one is conscious or not relies heavily on behavioral observations. The problem with this approach is that behavior represents an indirect and often ambiguous sign of consciousness. The same behavior (eg extension of the arm) may reflect a purposeful response to the environment (ie intent to localize an object) or a reflexive response (decerebrate posturing) to a noxious stimulus. Functional MRI procedures that employ passive stimulation paradigms are uniquely equipped to investigate the neural basis of mental activity in minimally or unresponsive patients. fMRI provides a novel means of searching for neurophysiologic signs of cognition in patients who fail to demonstrate concomitant behavioral evidence.

Basis for accomplishment. This accomplishment relates to Objective #2 of our plan of research. We plan to determine the integrity of cortical networks underlying language and visual processing in persons in MCS who fail to demonstrate reliable behavioral evidence of intact function in these areas.

Award: H133A020516 ID: 430, , ,                 01-Oct-02 to 30-Sep-07
Grant Title: VCU Traumatic Brain Injury Model System
Host Institution/Grantee Name: Virginia Commonwealth University
Principal Investigator: Kreutzer, Jeffrey
Program Mechanism: Model System
Funding per year: $365,000

Accomplishment. A special issue of Journal of Head Trauma Rehabilitation was edited by J. Kreutzer and R. Kennedy. Focus of the issue was entirely on the evaluation and treatment of depression following TBI. The results of this special issue are relevant to rehabilitation professionals and researchers alike.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The Evaluation and Treatment of Depression issue of Journal of Head Trauma Rehabilitation was disseminated in January 2006 (in print in December 2005, volume 20, number 6). Readership of the Journal of Head Trauma Rehabilitation approximates 15,000. Relevant publications in this issue include: Cantor, J., Ashman, T., Schwartz, M., Gordon, W., Hibbard, M., Brown, M. Spielman, L., Charatz, H., & Cheng, Z. (2005). The role of self-discrepancy theory in understanding post-traumatic brain injury affective disorders: A pilot study. Journal of Head Trauma Rehabilitation, 20(6), 527-543. Evans, C.C., Sherer, M., Nick, T.G., Nakase-Richardson, R., & Yablon, S. (2005). Early impaired self-awareness, depression, and subjective well-being following traumatic brain injury. Journal of Head Trauma Rehabilitation, 20(6), 488-500. Fann, J.R., Bombardier, C.H., Dikmen, S., Esselman, P., Warms, C.A., Pelzer, E., Rau, H., & Temkin, N. (2005). Validity of the patient health questionnaire-9 in assessing depression following TBI. Journal of Head Trauma Rehabilitation, 20(6), 501-511. Kennedy, R., Livingston, L., Riddick, A., Marwitz, J., Kreutzer, J., & Zasler, N. (2005). Evaluation of the Neurobehavioral Functioning Inventory as a depression screening tool after traumatic brain injury. Journal of Head Trauma Rehabilitation, 20(6), 512-526.

Documentation. The Journal of Head Trauma Rehabilitation, 20 (6) can be found in the National Library of Health.

Citation. See list of citations above.

Web site: www.headtraumarehab.com

Problem addressed. Mood disorders, particularly depression, are the one of the most common complications of TBI. The literature in this area consists primarily of case reports and case series with few multi-site or randomized controlled studies. This issue of the Journal of Head Trauma Rehabilitation provides a comprehensive review of diagnostic and etiologic considerations for rehabilitation providers and researchers. Written by NIDRR-funded researchers at four of the TBI Model Systems sites, important information is disseminated to a large audience.

Basis for accomplishment. This accomplishment is related to the Evaluation of Depression Diagnosis and Measurement Techniques study and the Pharmacological Intervention in Depression after Traumatic Brain Injury study.

Award: H133G010132 ID: 438,   01-Oct-01 to 30-Mar-06
Grant Title: Randomized Controlled Trial of Anti-fatiguing Exercise to Improve Function in Multiple Sclerosis Patients
Host Institution/Grantee Name: SUNY Research Foundation
Principal Investigator: Fisher, Nadine
Program Mechanism: Field Initiated Project
Funding per year: $150,000

Accomplishment. Two presentations were made at the American Academy of Neurology Annual meeting in April 2006. The results from the first presentation had an impact on MS patients and health care professionals by providing evidence for the importance of resistance exercise (particularly supervised exercise) to improve strength, endurance and contraction speed, thereby improving or maintaining the ability to do everyday functional tasks, such as walking and climbing stairs. It is also important as these results provide the first evidence (using a randomized controlled trial) showing that resistance training is not detrimental to people with MS and that they can improve their muscular function and functional performance, not just maintain it until the disease progresses. The second presentation provided evidence that the patients' perception of their fatigue does not correlate with their actual core temperature. This has a great impact on patients and health care workers alike, as exercising (raising core temperature) and working in warmer environments have long been discouraged for MS patients since they were thought to cause fatigue. These results provide the early evidence that this recommendation may not be entirely necessary and that symptom (i.e. fatigue) management may be accomplished through various means like cooling or specifically designed exercise programs. These results will be further explored in our other NIDRR-funded Field-Initiated Project, "Effects of Cooling and Fitness on Exercise Performance in Individuals with MS".

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. We presented two papers that reported on some of the results of the study. The first paper, "Supervised Resistance Training Improves Muscle Function in Individuals with Multiple Sclerosis". This paper discussed that MS patients had decreased muscle function (muscular strength, endurance, contraction speed) and functional performance (walking, stair climbing) compared to individuals without MS. In addition, those who participated in any of the exercise programs (supervised resistance training, home-based resistance training, or functional training) had improvements in muscle function and functional performance compared to the MS patients in the control group who showed decreases. The supervised resistance exercise program showed the greatest improvements compared to the other two exercise programs. The second presentation was entitled, "Relationship of Core Temperature to Physical Activity and Fatigue in MS". This paper discussed that there were significant changes in core temperature and fatigue for MS and non-MS individuals over 1.5 days, although there was a trend towards higher core temperatures for MS; abnormal thermoregulation was not evident. Although fatigue was higher in MS over time, perceived fatigue was not correlated with an increase in core temperature. The attendees of the meeting were neurologists, nurse practitioners in neurology, nurses, physical and occupational therapists, neuropsychologists and other health professionals. Both presenters had several conversations with neurologists who care for MS patients about the results of the study. The results of the presentations gave them more information with which to make knowledgeable decisions for patient care and to provide information to their patients about exercise recommendations and management of symptoms.

Documentation. The abstracts for these presentations can be found in the journal Neurology, vol.66 Supplement, pages A238 and A239, 2006.

Citation. Graham JE & NM Fisher. (2006). Supervised resistance training improves muscle function in individuals with multiple sclerosis. Neurology 66(5)Suppl 2:A239. Fisher NM & JE Graham. (2006). Relationship of core temperature to physical activity and fatigue in MS. Neurology 66(5)Suppl 2:A238.

Problem addressed. The most common symptom of MS is fatigue. Fatigue can affect the ability of MS patients to work a normal workday and/or week and has been recognized by the Social Security Administration as a cause of MS-related disability. In addition, fatigue often leads to a reduction in physical activity. This rationale led us to study the effects of a simulated workday (and the residual fatigue on the next morning) on a group of MS patients with mild to moderate disability (Goal 1 of study). It is well known that in the normal population, exercise and physical activity can reduce fatigue and increase endurance and ultimately, decrease the risk of developing other chronic heath conditions. Previous reports have indicated that people with MS can exercise; however, no one (until us) has studied the impact of resistance training on MS patients. Since muscle function (strength, endurance, etc.) is the major limitation for functional activities compared to aerobic function in this population (as established by our earlier pilot studies), a randomized controlled trial was needed to not only study the impact of a specifically designed and individualized resistance training program, but also the effectiveness of how it was delivered (i.e. supervised, home-based). This led us to study the effects of the three 12-week resistance training programs. Lastly, due to the fear of raising body temperature and increasing fatigue, many MS patients are told to either not exercise or not exercise to the level where they got heated or began to sweat. Since there were no studies showing that MS patients were more affected than non-MS by heat when exercising and because exercise can be a method of fatigue management, we measured the core body temperature over the 1.5 days of testing. Our pilot study showed that over this time interval, core body temperature was not significantly different between MS and non-MS individuals and that core temperature was not correlated with the patients' perception of their physical or cognitive fatigue. Through our randomized controlled trial, we were able to show that when given the correct type and progression of resistance exercise, MS patients can improve their muscle function, functional activities, and reduce their fatigue levels.

Basis for accomplishment. Accomplishment is based on completion of study protocols and analyses of the data.

Award: H133G020137 ID: 460,   01-Jan-03 to 31-Dec-06
Grant Title: Improving Muscular Use and Cardiorespiratory Demand in Spinal Cord Injured Patients Performing Functional Electrical Stimulated Leg Cycle Ergometry
Host Institution/Grantee Name: University of California at Davis
Principal Investigator: Hull, Maury
Program Mechanism: Field Initiated Project
Funding per year: $144,845

Accomplishment. By testing different excitation waveforms in forward dynamic simulations of different tasks, we produced a paper titled ""Sloped Excitation Waveforms Improve the Accuracy of Forward Dynamic Simulations" which was presented at the 2006 Summer Bioengineering Conference. The abstract for this paper is included in the conference proceedings and the URL to download the title of the paper is given below. The full text of this paper will appear shortly in the Journal of Biomechanics.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. We demonstrated that the accuracy of forward dynamic simulations can be improved by using sloped excitation waveforms instead of rectangular waveforms. This accomplishment is significant because forward dynamic simulations have been used to study many activities including the present one of FES pedaling. The work related to this accomplishment was not among the original objectives described in the Abstract. In developing the forward dynamic model to simulate recumbent pedaling, we noticed that the EMG recordings were not well represented by rectangular waveforms which have been used in all previous research on pedaling simulations. Accordingly to improve the accuracy of the forward dynamic simulation of recumbent pedaling, we concurrently studied the ability of sloped excitation waveforms to improve the accuracy of forward dynamic simulations. The results of this additional work are described in a paper which is in press. To perform this study, we used a simple and well controlled elbow extension task in addition to the pedaling task. One objective was to demonstrate that sloped as opposed to rectangular excitation waveforms improve the accuracy of forward dynamic simulations. A second objective was to demonstrate the differences in simulated muscle forces using sloped versus rectangular waveforms. To fulfill these objectives, surface EMG signals from the triceps brachii and elbow joint angle were recorded and the intersegmental moment of the elbow joint was computed from fourteen subjects who performed two cyclic elbow extension experiments at 200 and 300 deg/s. Additionally the surface EMG signals from the leg musculature, joint angles, and pedal forces were recorded and joint intersegmental moments were computed during a more complex recumbent pedaling task (90 rpm at 250 W). Using forward dynamic simulations, four optimizations were performed in which the experimental intersegmental moment was tracked for the elbow extension tasks and four optimizations were performed in which the experimental pedal angle, pedal forces, and joint intersegmental moments were tracked for the pedaling task. In these optimizations the three parameters (onset and offset time, and peak amplitude) defining the sloped (triangular, quadratic, and Hanning) and rectangular excitation waveforms simulated and experimentally tracked quantities. For the elbow extension task, the intersegmental elbow moment root mean squared error (RMSE), onset timing error, and offset timing error were less from simulations using a sloped excitation waveform compared to a rectangular excitation waveform (p<0.001). The average and peak muscle forces were from 7 to 16% larger and 20 to 28% larger respectively, when using a rectangular excitation waveform. The tracking error for pedaling also decreased when using a sloped excitation waveform, with the quadratic waveform generating the smallest tracking errors for both tasks. These results support the use of sloped over rectangular excitation waveforms to establish greater confidence in the results of forward dynamic simulations.

Documentation. A manuscript describing this accomplishment has been accepted for publication in the Journal of Biomechanics and will appear shortly. The title of the manuscript is "Sloped Excitation Waveforms Improve the Accuracy of Forward Dynamic Simulations" and the authors are Camilleri, M., Hull, M. L., and Hakansson, N.

Citation. Camilleri, M. and Hull, M. L. Sloped Excitation Waveforms Improve the Accuracy of Forward Dynamic Simulations, in V. Goel, S. Rastegar, B. Lieber, and O. Akkus eds, 2006 Summer Bioengineering Conference, pp BIO2006-157269, Amelia Island, FL: ASME

Web site: www.x-cd.com/sbc06/prof50.html

Problem addressed. The accomplishment addressed a very broad need which is to improve the accuracy of forward dynamic simulations. This need is particularly relevant to the current project because the project uses forward dynamic simulation as a tool to 'design' new patterns for electrically stimulated muscles for spinal cord individuals, our target population. Hence the ability of the new stimulation patterns to meet the project objectives (i.e. improved cardiorespiratory demand and muscular use) is directly tied to the accuracy of simulation results.

Basis for accomplishment. The project activity that led to this accomplishment was the development of the forward dynamic simulation of recumbent pedaling and the collection of EMG recordings indicating muscle excitations during recumbent pedaling.

Award: H133A020102 ID: 464,   01-Oct-02 to 30-Sep-07
Grant Title: Pediatric Burn Injury Rehabilitation Model System
Host Institution/Grantee Name: University of Texas Medical Branch
Principal Investigator: Herndon, David
Program Mechanism: Model System
Funding per year: $300,000

Accomplishment. We published a paper that reported new results demonstrating that the administration of oxandrolone for one year post injury significantly improved lean body mass, muscle strength and bone mineral content for children with burns equal to or more than 40% Total Body Surface Area, thus facilitating early rehabilitation and stronger bodies for survivors of massive burns.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. Sixty-one children with 40% or greater total body surface area burns were randomized into one group to receive oxandrolone (n = 30) or a group to receive placebo (n = 31) for the first 12 months post injury. Treatment was discontinued after 12 months, and the patients were studied without the drug for the following 12 months. At discharge and 6, 12, 18, and 24 months after burn, height, weight, body composition, resting energy expenditure, muscle strength, and serum human growth hormone, insulin-like growth factor-I (IGF-1), IGF binding protein-3, insulin, cortisol, parathyroid hormone, tri-iodothyronine uptake (T3 uptake), and free thyroxine index (FTI) were measured. Results were that oxandrolone improved lean body mass, bone mineral content and muscle strength compared with controls during treatment, P < 0.05. Serum IGF-1, T3 uptake, and FTI were significantly higher during drug treatment compared with controls, P < 0.05. Significant increases in height and weight with oxandrolone were observed to continue after the end of treatment.

Documentation. The results were written and published in a peer reviewed journal. The citation is: Przkora R, Jeschke MG, Barrow RE, Suman OE, Meyer WJ, Finnerty CC, Sanford AP, Lee J, Chinkes DL, Mlcak RP, Herndon DN. Metabolic and Hormonal Changes of Severely Burned Children Receiving Long-Term Oxandrolone Treatment. Annals of Surgery, 242(3):384-391, 2005.

Web site: www.annalsofsurgery.com/pt/re/annos/abstract.00000658-200509000-00009.htm

Problem addressed. Severe burn (burns of 40% or greater TBSA) causes metabolic disturbances that can last for a year after injury; persistent and profound catabolism hampers rehabilitative efforts and delays meaningful reintegration of individuals to society.

Basis for accomplishment. The accomplishment was based on the study 1: Efficacy Of Treatment Of Major Burns With Anabolic Agents During The First Year Post Discharge. Oxandrolone was the anabolic agent originally chosen for this funding period, but the results discussed here were so convincing that we then broadened the study to examine several anabolic agents. The work is on-going.

Award: H133A020101 ID: 469,   01-Oct-02 to 30-Sep-07
Grant Title: Johns Hopkins University Burn Injury Rehabilitation Model System
Host Institution/Grantee Name: Johns Hopkins University
Principal Investigator: Fauerbach, James A.
Program Mechanism: Model System
Funding per year: $299,911

Accomplishment. The NIDRR-funded Augmented Exercise Program (AEP) was a randomized, controlled, trial (RCT) of 2 enhanced, aerobic exercise protocols relative to usual care. The AEP produced new findings regarding improved methods of treating generalized deconditioning among patients with burn injury. The JHU-BIMS conducted several activities that resulted in an abstract presented at the annual conference of the American Burn Association (ABA) and published in its Proceedings in a Supplement to the Journal of Burn Care and Rehabilitation. The abstract and the presentation provided data that demonstrated the efficacy of aerobic conditioning on decreasing generalized deconditioning in burn survivors. An additional component of this accomplishment was the completion of an adherence study. We evaluated the impact of cognitive factors and depression at baseline on completion versus dropout from the exercise protocol.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The AEP study was an RCT of its 2 aerobic conditioning protocols relative to usual care. The aim of this trial was to, specifically, contrast the usual care condition alone, Standard Functional Restoration (SFR) , with an experimental treatment, SFR plus an enhanced Aerobic Exercise Program (AEP). Participants randomized to AEP were advanced through the program by either a work to tolerance (WTT) or work to quota (WTQ) goal setting schedule. WTT and the WTQ participants improved significantly more in aerobic capacity (VO2 max) relative to those receiving SFR alone. As a substudy, we evaluated participant dropout. Aerobic Training Component of Augmented Exercise Program These results are documented in the abstract in the citation section below (de Lateur et al, 2006). The objective of the present trial was to investigate the efficacy of a formal 12-week augmented conditioning program on the improvement of aerobic capacity among burn survivors. Subjects were 30 adult outpatients who were enrolled in a 12-week randomized, blinded, controlled trial of augmented aerobic training following burn injury. Subjects were randomly assigned to one of three groups: SFR, WTQ, and WTT. All 3 groups received SFR. In addition, WTQ and WTT subjects participated in tailored-to-condition ambulation protocols 3 days/week for 12 weeks. At baseline and completion of study protocol, subjects underwent cardiovascular stress tests and maximum volume of oxygen consumption was the measure of aerobic capacity. Over the 12-week treatment period both the WTQ and WTT group subjects demonstrated significant improvement in aerobic capacity as measured by VO2 Max, whereas the SFR group members did not. Additionally, when we examined the interaction between time and group on VO2 Max, both the treatment groups showed significantly greater improvement relative to the SFR group, but did not differ from each other. The findings from this trial suggest that burn survivors benefit from regular aerobic training. Adherence Component of Augmented Exercise Program Effect of Psychological Factors on Adherence to an Exercise Program Among Burn Survivors. These results are documented in the abstract in the citation section below (Magyar-Russell, et al., 2006). Adherence to rehabilitation activities following burn injury is a critical component of regaining physical and social functioning. The factors that negatively influence adherence are not well understood. The objective of the present study was to assess the role of specific psychological factors on the successful completion of a 12-week exercise program in a sample of burn survivors. Subjects were 30 adult outpatients who were enrolled in a randomized, controlled clinical trial of augmented strength and aerobic training following burn injury. Findings suggest that individuals who did not complete the 12-week exercise protocol reported higher levels of depressive symptoms at baseline in comparison to subjects who did complete the protocol. Additionally, completers reported greater perceptions of susceptibility to chronic physical problems and functional limitations resulting from their burn injury than did non-completers. Results support the notion that psychological factors play an important role in adherence to physical rehabilitation activities.

Documentation. These project activities and findings are documented in the abstract published from the Proceedings of the American Burn Association annual conference: Supplement to the Journal of Burn Care and Research, March 2006, Volume 27 (2), pp. S103 and S118. Further documentation will be available next year in the forthcoming special issue of the Archives of Physical Medicine and Rehabilitation (Spring, 2007).

Citation. 1) Aerobic Exercise Trial: deLateur, BJ, Ober, MS, Bresnick, MG, Magyar-Russell, G., Thombs, BD, & Fauerbach, JA. (2006). Randomized, Controlled Trial of an Augmented Exercise Protocol in the Prevention of Deconditioning among Burn Survivors: A Preliminary Analysis. Proceedings of the ABA: Supplement to the Journal of Burn Care and Research, 27(2), pS118.
2) Effects of Cognitive Factors and Depression on Adherence: Magyar-Russell, G, Bresnick, MG, deLateur, BJ, Fauerbach, JA, Ober, MS, Thombs, BD, & Notes, BA. (2006). The Impact of Psychological Factors on Adherence to a Therapeutic Exercise Program Among Burn Survivors. Proceedings of the ABA: Supplement to the Journal of Burn Care and Research, 27(2), pS103.
3) Aerobic Exercise Study: deLateur, BJ, Magyar-Russell, G, Ober, MS, Bresnick, MG, & Fauerbach, JA. A Randomized, Controlled Trial of an Augmented Exercise Protocol in the Prevention of Deconditioning among Burn Survivors. Manuscript in review for the special issue of Archives of Physical Medicine and Rehabilitation (Spring 2007).

Problem addressed. Fatigue, often a factor delaying the return to work and other activities of daily living, is a frequent complaint of patients suffering a major burn. In a study of outcome of patients with major burns, local muscle strength, relative endurance and absolute endurance were measured and compared to that of age- and sex-matched controls. Somewhat surprisingly, the relative endurance was approximately equal to that of the normals. It was the strength and absolute endurance of the muscle that was deficient in these patients. With no exercise intervention, the strength of these patients did not approach that of the controls until two years post burn (deLateur, BJ et al, unpublished data). The expectation is that "ordinary activities" at home will not restore pre-burn strength and stamina. Total body surface area (TBSA) burned and age may represent confounding variables. These expectations are supported by a 1998 study by St-Pierre and colleagues who found that patients who had burns greater than 30% TBSA showed deficits in torque, power, and work in the flexors and extensors of the elbow and knee. These deficits lasted for years (St-Pierre, 1998). Importantly, children with greater than 40% TBSA burns who performed a structured progressive exercise program made greater improvements in strength and functional outcome than did those with only the usual home care; however, no such study exists for adults (Cucuzzo, 2001). Extension contractures (loss of flexion range) are almost as debilitating as flexion contractures (loss of extension range). Positioning is of overwhelming importance in the prevention of contracture, and contractures can develop in as little as two weeks. Studies using animal models have shown that if muscle, tendon, scar or other connective tissue is positioned short, it becomes short; if it is positioned long, it stays long. (Stolov, 1966). Ranging activity and positioning have been used in attempting to prevent and reduce contractures. However, there are no data assessing the efficacy of such interventions in burn patients. The Health Beliefs Model includes the following beliefs each of which found substantial support in predicting adherence in various nonburn populations: (a) perceived severity of the problems that will result from not adhering; (b) perceived likelihood of those problems if nonadherent; (c) appraised "barriers" (i.e., benefits vs. costs of adherence), (d) perceived utility that treatment adherence will have in reducing (a) or (b) or both. The best predictor of later adherence was degree of adherence at study intake. The goal of our study is to investigate the efficacy of a formal, 12-week program of strength and aerobic training in promoting return to fitness, reducing the prevalence of joint contractures and improving adherence to an exercise program. We compared the effect of a standard functional restoration (SFR) with an augmented exercise plus standard functional restoration with work to tolerance (WTT) schedule versus a work to quota (WTQ) schedule. (Ehde, 1998) Outcome measures were analyzed to monitor the recovery of aerobic capacity, change in strength, return to work, prevalence of contractures, self-selected walking speed (Silverberg, 2000), and identification of cognitive risk factors for postdischarge nonadherence.

Basis for accomplishment. There are several project activities supporting this accomplishment. These included screening, recruiting, and running participants through assessment and intervention protocols. Data collected were entered, stored and analyzed. Thorough reading of related literature and intense discussion of the findings helped target the analyses. Multiple revising of presentation and publication by study members led to a higher quality output. Additional activities also contributed to the accomplishment. First, we were awarded continued grant funding from the local Johns Hopkins Burn Center Community Fund (in cooperation with Metro Fire Fighters Community Fund). This produced an increase in enrollment activity due to more staff time dedicated to this project and more consistent availability of staff to conduct participant recruitment, data collection, and data analyses activities. This in turn resulted in activities presentations and publications of results at local and national conferences and in a scientific journal, as well as collaboration with other investigators (Herndon et al) to work toward developing and carrying out future directions of this study. For example, now that we have demonstrated that aerobic exercise adds unique conditioning benefits to burn survivors, we plan to test whether administering a pharmacologic intervention to the protocol adds incrementally to this benefit, or if it produces equivalent results to aerobic training following burn injury. Finally, based on the literature review and findings from this research, physical medicine and rehabilitation residents at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center are now required to take a course on the impact of aerobic conditioning in the treatment of chronic medical conditions.

Award: H133P040003 ID: 528,   01-Jul-04 to 30-Jun-09
Grant Title: Interdisciplinary Rehabilitation Research Training
Host Institution/Grantee Name: University of Texas Medical Branch (UTMB)
Principal Investigator: Ottenbacher, Kenneth
Program Mechanism: Advanced Rehabilitation Research Training
Funding per year: $145,686

Accomplishment. Current NIDRR fellow Dr. Al Snih, along with project faculty, conducted and published a research study examining how pain can influence lower extremity muscle strength and lead to decreased physical function and reduced activities of daily living in older adults. This article demonstrates the importance of identifying, monitoring and managing pain in persons with disabilities and chronic disease.

Type. output (significant findings, publication, product, or service delivered)

Description of accomplishment and supporting evidence. The accomplishment involved the examination of 544 older adult participants at risk for disability. 244 reported pain on weight bearing. We collected information on muscle strength, ADLs, IADLs, and measures of community integration. We found the presence of pain was associated with decreased muscle strength in women and decreased physical function and ADLs in both men and women. The findings from the study were prepared for publication and submitted for review in a major peer reviewed rehabilitation research journal. The paper was reviewed, revised and accepted during a period of approximately 15 months.

Documentation. Documentation of the research is available in the form of completed data collection forms, printouts of statistical analyses, early versions of the manuscript and comments and correspondence from the journal referees and editors. The article was published during the current reporting period and is available both on-line and in the hardcopy of the journal (Archives of Physical Medicine and Rehabilitation). See citation below.

Citation. Al Snih S, Raji M, Peek MK, Ottenbacher KJ. Pain, lower extremity muscle strength, and physical function among older Mexican Americans. Arch Phys Med Rehabil 2005; 86:1394-1400. Impact factor 1.70

Web site: http://journals.elsevierhealth.com/periodicals/yapmr

Problem addressed. Pain is a significant problem in persons with disabilities and chronic disease.

Basis for accomplishment. Project activities included specific training and mentoring provided to fellows as part of research and career development activities.

---

Return to:
Annual Performance Assessment Expert Review
Table of Contents

Top

Return to:

NIDRR Announcements
or


NIDRR's Web site
or

National Center for the Dissemination of Disability Research Home page

---