Physical Therapy - Dictionary

PHYSICAL THERAPY A MEDICAL DICTIONARY, BIBLIOGRAPHY, AND ANNOTATED RESEARCH GUIDE TO INTERNET REFERENCES JAMES N. PARKER, M.D. AND PHILIP M. PARKER, PH.D., EDITORS

ii ICON Health Publications ICON Group International, Inc. 4370 La Jolla Village Drive, 4th Floor San Diego, CA 92122 USA Copyright 2004 by ICON Group International, Inc. Copyright 2004 by ICON Group International, Inc. All rights reserved. This book is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without written permission from the publisher. Printed in the United States of America. Last digit indicates print number: 10 9 8 7 6 4 5 3 2 1 Publisher, Health Care: Philip Parker, Ph.D. Editor(s): James Parker, M.D., Philip Parker, Ph.D. Publisher's note: The ideas, procedures, and suggestions contained in this book are not intended for the diagnosis or treatment of a health problem. As new medical or scientific information becomes available from academic and clinical research, recommended treatments and drug therapies may undergo changes. The authors, editors, and publisher have attempted to make the information in this book up to date and accurate in accord with accepted standards at the time of publication. The authors, editors, and publisher are not responsible for errors or omissions or for consequences from application of the book, and make no warranty, expressed or implied, in regard to the contents of this book. Any practice described in this book should be applied by the reader in accordance with professional standards of care used in regard to the unique circumstances that may apply in each situation. The reader is advised to always check product information (package inserts) for changes and new information regarding dosage and contraindications before prescribing any drug or pharmacological product. Caution is especially urged when using new or infrequently ordered drugs, herbal remedies, vitamins and supplements, alternative therapies, complementary therapies and medicines, and integrative medical treatments. Cataloging-in-Publication Data Parker, James N., 1961- Parker, Philip M., 1960- Physical Therapy: A Medical Dictionary, Bibliography, and Annotated Research Guide to Internet References / James N. Parker and Philip M. Parker, editors p. cm. Includes bibliographical references, glossary, and index. ISBN: 0-597-84166-7 1. Physical Therapy-Popular works. I. Title.

iii Disclaimer This publication is not intended to be used for the diagnosis or treatment of a health problem. It is sold with the understanding that the publisher, editors, and authors are not engaging in the rendering of medical, psychological, financial, legal, or other professional services. References to any entity, product, service, or source of information that may be contained in this publication should not be considered an endorsement, either direct or implied, by the publisher, editors, or authors. ICON Group International, Inc., the editors, and the authors are not responsible for the content of any Web pages or publications referenced in this publication. Copyright Notice If a physician wishes to copy limited passages from this book for patient use, this right is automatically granted without written permission from ICON Group International, Inc. (ICON Group). However, all of ICON Group publications have copyrights. With exception to the above, copying our publications in whole or in part, for whatever reason, is a violation of copyright laws and can lead to penalties and fines. Should you want to copy tables, graphs, or other materials, please contact us to request permission (E-mail: [email protected]). ICON Group often grants permission for very limited reproduction of our publications for internal use, press releases, and academic research. Such reproduction requires confirmed permission from ICON Group International, Inc. The disclaimer above must accompany all reproductions, in whole or in part, of this book.

iv Acknowledgements The collective knowledge generated from academic and applied research summarized in various references has been critical in the creation of this book which is best viewed as a comprehensive compilation and collection of information prepared by various official agencies which produce publications on physical therapy. Books in this series draw from various agencies and institutions associated with the United States Department of Health and Human Services, and in particular, the Office of the Secretary of Health and Human Services (OS), the Administration for Children and Families (ACF), the Administration on Aging (AOA), the Agency for Healthcare Research and Quality (AHRQ), the Agency for Toxic Substances and Disease Registry (ATSDR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Healthcare Financing Administration (HCFA), the Health Resources and Services Administration (HRSA), the Indian Health Service (IHS), the institutions of the National Institutes of Health (NIH), the Program Support Center (PSC), and the Substance Abuse and Mental Health Services Administration (SAMHSA). In addition to these sources, information gathered from the National Library of Medicine, the United States Patent Office, the European Union, and their related organizations has been invaluable in the creation of this book. Some of the work represented was financially supported by the Research and Development Committee at INSEAD. This support is gratefully acknowledged. Finally, special thanks are owed to Tiffany Freeman for her excellent editorial support.

v About the Editors James N. Parker, M.D. Dr. James N. Parker received his Bachelor of Science degree in Psychobiology from the University of California, Riverside and his M.D. from the University of California, San Diego. In addition to authoring numerous research publications, he has lectured at various academic institutions. Dr. Parker is the medical editor for health books by ICON Health Publications. Philip M. Parker, Ph.D. Philip M. Parker is the Eli Lilly Chair Professor of Innovation, Business and Society at INSEAD (Fontainebleau, France and Singapore). Dr. Parker has also been Professor at the University of California, San Diego and has taught courses at Harvard University, the Hong Kong University of Science and Technology, the Massachusetts Institute of Technology, Stanford University, and UCLA. Dr. Parker is the associate editor for ICON Health Publications.

vi About ICON Health Publications To discover more about ICON Health Publications, simply check with your preferred online booksellers, including Barnes&Noble.com and Amazon.com which currently carry all of our titles. Or, feel free to contact us directly for bulk purchases or institutional discounts: ICON Group International, Inc. 4370 La Jolla Village Drive, Fourth Floor San Diego, CA 92122 USA Fax: 858-546-4341 Web site: www.icongrouponline.com/health

vii Table of Contents FORWARD .......................................................................................................................................... 1 CHAPTER 1. STUDIES ON PHYSICAL THERAPY.................................................................................. 3 Overview........................................................................................................................................ 3 The Combined Health Information Database................................................................................. 3 Federally Funded Research on Physical Therapy........................................................................... 4 E-Journals: PubMed Central ....................................................................................................... 54 The National Library of Medicine: PubMed ................................................................................ 54 CHAPTER 2. ALTERNATIVE MEDICINE AND PHYSICAL THERAPY ................................................. 97 Overview...................................................................................................................................... 97 The Combined Health Information Database............................................................................... 97 National Center for Complementary and Alternative Medicine.................................................. 98 Additional Web Resources ........................................................................................................... 98 General References ..................................................................................................................... 102 CHAPTER 3. DISSERTATIONS ON PHYSICAL THERAPY ................................................................. 103 Overview.................................................................................................................................... 103 Dissertations on Physical Therapy ............................................................................................ 103 Keeping Current ........................................................................................................................ 115 CHAPTER 4. CLINICAL TRIALS AND PHYSICAL THERAPY ............................................................ 117 Overview.................................................................................................................................... 117 Recent Trials on Physical Therapy ............................................................................................ 117 Keeping Current on Clinical Trials ........................................................................................... 118 CHAPTER 5. PATENTS ON PHYSICAL THERAPY ............................................................................ 121 Overview.................................................................................................................................... 121 Patents on Physical Therapy...................................................................................................... 121 Patent Applications on Physical Therapy.................................................................................. 148 Keeping Current ........................................................................................................................ 162 CHAPTER 6. BOOKS ON PHYSICAL THERAPY................................................................................ 163 Overview.................................................................................................................................... 163 Book Summaries: Federal Agencies............................................................................................ 163 Book Summaries: Online Booksellers......................................................................................... 164 The National Library of Medicine Book Index ........................................................................... 166 Chapters on Physical Therapy ................................................................................................... 166 CHAPTER 7. MULTIMEDIA ON PHYSICAL THERAPY ..................................................................... 169 Overview.................................................................................................................................... 169 Video Recordings ....................................................................................................................... 169 Bibliography: Multimedia on Physical Therapy ........................................................................ 171 CHAPTER 8. PERIODICALS AND NEWS ON PHYSICAL THERAPY .................................................. 173 Overview.................................................................................................................................... 173 News Services and Press Releases.............................................................................................. 173 Newsletters on Physical Therapy............................................................................................... 175 Newsletter Articles .................................................................................................................... 176 Academic Periodicals covering Physical Therapy ...................................................................... 177 CHAPTER 9. RESEARCHING MEDICATIONS .................................................................................. 179 Overview.................................................................................................................................... 179 U.S. Pharmacopeia..................................................................................................................... 179 Commercial Databases ............................................................................................................... 180 APPENDIX A. PHYSICIAN RESOURCES .......................................................................................... 185 Overview.................................................................................................................................... 185 NIH Guidelines.......................................................................................................................... 185 NIH Databases........................................................................................................................... 187 Other Commercial Databases..................................................................................................... 191

viii Contents APPENDIX B. PATIENT RESOURCES............................................................................................... 193 Overview.................................................................................................................................... 193 Patient Guideline Sources.......................................................................................................... 193 Finding Associations.................................................................................................................. 200 APPENDIX C. FINDING MEDICAL LIBRARIES ................................................................................ 203 Overview.................................................................................................................................... 203 Preparation................................................................................................................................. 203 Finding a Local Medical Library................................................................................................ 203 Medical Libraries in the U.S. and Canada ................................................................................. 203 ONLINE GLOSSARIES................................................................................................................ 209 Online Dictionary Directories ................................................................................................... 209 PHYSICAL THERAPY DICTIONARY ...................................................................................... 211 INDEX .............................................................................................................................................. 265

1 FORWARD In March 2001, the National Institutes of Health issued the following warning: \"The number of Web sites offering health-related resources grows every day. Many sites provide valuable information, while others may have information that is unreliable or misleading.\"1 Furthermore, because of the rapid increase in Internet-based information, many hours can be wasted searching, selecting, and printing. Since only the smallest fraction of information dealing with physical therapy is indexed in search engines, such as www.google.com or others, a non-systematic approach to Internet research can be not only time consuming, but also incomplete. This book was created for medical professionals, students, and members of the general public who want to know as much as possible about physical therapy, using the most advanced research tools available and spending the least amount of time doing so. In addition to offering a structured and comprehensive bibliography, the pages that follow will tell you where and how to find reliable information covering virtually all topics related to physical therapy, from the essentials to the most advanced areas of research. Public, academic, government, and peer-reviewed research studies are emphasized. Various abstracts are reproduced to give you some of the latest official information available to date on physical therapy. Abundant guidance is given on how to obtain free-of-charge primary research results via the Internet. While this book focuses on the field of medicine, when some sources provide access to non-medical information relating to physical therapy, these are noted in the text. E-book and electronic versions of this book are fully interactive with each of the Internet sites mentioned (clicking on a hyperlink automatically opens your browser to the site indicated). If you are using the hard copy version of this book, you can access a cited Web site by typing the provided Web address directly into your Internet browser. You may find it useful to refer to synonyms or related terms when accessing these Internet databases. NOTE: At the time of publication, the Web addresses were functional. However, some links may fail due to URL address changes, which is a common occurrence on the Internet. For readers unfamiliar with the Internet, detailed instructions are offered on how to access electronic resources. For readers unfamiliar with medical terminology, a comprehensive glossary is provided. For readers without access to Internet resources, a directory of medical libraries, that have or can locate references cited here, is given. We hope these resources will prove useful to the widest possible audience seeking information on physical therapy. The Editors 1 From the NIH, National Cancer Institute (NCI): http://www.cancer.gov/cancerinfo/ten-things-to-know.



3 CHAPTER 1. STUDIES ON PHYSICAL THERAPY Overview In this chapter, we will show you how to locate peer-reviewed references and studies on physical therapy. The Combined Health Information Database The Combined Health Information Database summarizes studies across numerous federal agencies. To limit your investigation to research studies and physical therapy, you will need to use the advanced search options. First, go to http://chid.nih.gov/index.html. From there, select the “Detailed Search” option (or go directly to that page with the following hyperlink: http://chid.nih.gov/detail/detail.html). The trick in extracting studies is found in the drop boxes at the bottom of the search page where “You may refine your search by.” Select the dates and language you prefer, and the format option “Journal Article.” At the top of the search form, select the number of records you would like to see (we recommend 100) and check the box to display “whole records.” We recommend that you type “physical therapy” (or synonyms) into the “For these words:” box. Consider using the option “anywhere in record” to make your search as broad as possible. If you want to limit the search to only a particular field, such as the title of the journal, then select this option in the “Search in these fields” drop box. The following is what you can expect from this type of search: • The Effects of an AIDS Education Program on the Knowledge and Attitudes of a Physical Therapy Class Source: Physical Therapy; Vol. 73, No. 3. Contact: Daemen College, Department of Physical Therapy, PO Box 789, Amherst, NY, 14226. Summary: This article reports on an investigation to determine the effect of an education unit on entry-level undergraduate physical therapy students knowledge about AIDS, their attitudes towards patients with AIDS, and their willingness to treat patients who have AIDS. The data is analyzed and presented in tables. The results support observations that physical therapy students are not well prepared to treat AIDS patients and they are in need of appropriate discipline-specific AIDS education. The author

4 Physical Therapy concludes follow-up research, as well as further study of other levels of physical therapy students, measurement of actual practice behaviors, and comparison of different educational interventions is needed. • Physical Therapy for Management of RA Source: Journal of Musculoskeletal Medicine. 19(9): 352-364. September 2002. Summary: This journal article examines the role of physical therapy and exercise in managing the symptoms of rheumatoid arthritis (RA) and maximizing joint range of motion, endurance, and flexibility. Interventions should be initiated early in the disease course, before structural changes in the joints occur. Patient education helps patients perform exercises independently and adapt to fluctuations in disease activity. The physical therapy examination consists of taking the patient's history, performing a musculoskeletal exam, and assessing range of motion and muscular force. This examination helps determine appropriate interventions based on factors that include the extent and stage of joint impairments and general body conditioning. Goals of therapy during the active phase include reducing pain and maximizing joint range of motion; isometric and gentle range of motion exercises may be used. In the subacute disease stage, range of motion exercises can be increased and combined with flexibility and dynamic exercises such as swimming and aerobics. During inactive disease, patients may add higher-intensity strength and endurance training. 3 figures, 1 table, and 20 references. (AAM). • How To Manage Low Back Pain: Physical Therapy or Physical Training? Source: Journal of Musculoskeletal Medicine. 18(4): 182-184,187-189. April 2001. Summary: This journal article, the fourth in a special series on evaluation and management of back pain, provides health professionals with an overview of low back pain (LBP) and examines the debate over the effectiveness of physical therapy and physical training in managing it. The causes of LBP often cannot be specifically determined, so current treatment guidelines recommend taking minimal action. In many cases, clinicians suggest simple measures that patients can implement on their own. Which therapeutic approach to take is the subject of debate. One method, physical therapy, includes passive measures and active exercises for controlling pain. Physical training incorporates more specific, self-directed exercises geared to restoring fitness and preventing future symptoms. The lack of a clear distinction between approaches and the lack of well defined goals may lead to ill advised hybrid treatment. Proponents of both treatment methods should recognize the importance of patient response. People who suffer from back pain may benefit from a combination of passive and active modes of treatment. 1 table and 18 references. (AA-M). Federally Funded Research on Physical Therapy The U.S. Government supports a variety of research studies relating to physical therapy. These studies are tracked by the Office of Extramural Research at the National Institutes of Health.2 CRISP (Computerized Retrieval of Information on Scientific Projects) is a searchable 2 Healthcare projects are funded by the National Institutes of Health (NIH), Substance Abuse and Mental Health Services (SAMHSA), Health Resources and Services Administration (HRSA), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDCP), Agency for Healthcare Research and Quality (AHRQ), and Office of Assistant Secretary of Health (OASH).

Studies 5 database of federally funded biomedical research projects conducted at universities, hospitals, and other institutions. Search the CRISP Web site at http://crisp.cit.nih.gov/crisp/crisp_query.generate_screen. You will have the option to perform targeted searches by various criteria, including geography, date, and topics related to physical therapy. For most of the studies, the agencies reporting into CRISP provide summaries or abstracts. As opposed to clinical trial research using patients, many federally funded studies use animals or simulated models to explore physical therapy. The following is typical of the type of information found when searching the CRISP database for physical therapy: • Project Title: A BRIDGE BETWEEN THE ACADEMIC AND CLINICAL SETTING: EVI* Principal Investigator & Institution: Craik, Rebecca L.; Associate Professor; Physical Therapy; Arcadia University 450 S Easton Rd Glenside, Pa 19038 Timing: Fiscal Year 2002; Project Start 30-SEP-2002; Project End 29-MAY-2004 Summary: (provided by applicant): A Bridge between the Academic and Clinical Setting: Evidence-based Heatthcare Practice in the Clinic. Healthcare providers routinely make decisions affecting patients in daily care. Traditionally, such decisions have been based on such factors as experiences, intuition, lectures from teachers or colleagues, and findings from the research literature. Evidence-based medicine (EBM), on the other hand, is the integration of best research evidence with clinical expertise and patient values. Information technology makes access to scientific literature more available than ever before, but access to on-line services is still subject to the \"digital divide.\" Obstacles preventing health care providers from using databases such as PubMed or Medline to answer clinical questions include: lack of access to Internet, lack of skills to search databases effectively, and lack of confidence in evaluating research reports, among others. Arcadia University requests a grant that will better prepare undergraduate and graduate students in biology, psychology, and health sciences and also assist fifteen clinical sites to move towards the use of evidence-based medicine in their clinical practices. The program described here will merge the capabilities of the NLM Medline database with subscriptions to peer-reviewed journals so that Arcadia faculty and students and the professional staff at small health care facilities (where our students complete internships or clinical education rounds) may access full-text articles on-line. If funded, the grant will provide substantially improved medical research capabilities for students and faculty in the following graduate programs at Arcadia University: doctorate of physical therapy, master of science in physician assistant studies, master of science in genetic counseling, the master of science in public health, master of science in health education, and master of arts in counseling psychology programs. Undergraduate students and faculty in the psychology and biology departments will also make us of the medical library services. The grant will provide library access and services for clinical staff and students at fifteen smaller hospitals and healthcare institutions in rural and underserved urban locations. The institutions selected provide clinical education opportunities for our physical therapy, physician- assistant studies, and counseling psychology students. Grant-funded activities will include: two years subscription fees for approximately 55 peer-reviewed journals in the Allied Health field to be accessed by clinic sites and Arcadia students, a two-day training session on evidence-based practice, information literacy, and use of Medline database for clinicians from participating sites; a new Dell desktop computer for each participating clinic site dedicated to research, two years of cable Internet service for

6 Physical Therapy participating sites that don't already have lnternet access, website for cohort of clinic sites and student interns; and a symposium on evidence-based medicine for cohorts from clinic sites. The principal investigator is Rebecca Craik, professor and chair of the Department of Physical Therapy at Arcadia University. The planning team for this grant includes Param Bedi, head of information technology and Ann Ranieri, head of library technical services at Arcadia University. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: A TREATMENT FOR EXCESS MOTOR DISABILITY IN THE AGED Principal Investigator & Institution: Taub, Edward; Professor; Psychology; University of Alabama at Birmingham Uab Station Birmingham, Al 35294 Timing: Fiscal Year 2001; Project Start 09-DEC-1996; Project End 30-NOV-2003 Summary: Stroke afflicts over 700,000 persons in America every year. There is thus an urgent need to translate unique behavioral techniques shown to have an impact on plasticity of the nervous system into practical evidence-based therapeutic interventions, especially at a time when the duration of treatments has shortened. In this laboratory we have developed on such set of techniques derived from basic research with an8mal and human subjects. Randomized, controlled studies indicate that it can substantially reduce the motor deficit of patients with mild to moderate chronic strokes from the upper two quartiles of motor functioning and can increase their independence over a period of years. The techniques, termed Constrain- Induced (CI) Movement Therapy, involve motor restriction of the less affected upper extremity for a period of two or three weeks while at the same time training the more affected upper limb. This gives rise to massed or repetitive use of the more affected extremity and to a large increase in use-dependent cortical reorganization involving the recruitment of substantial new regions of the brain in the innervation of more-affected extremity movement. One of the main aims of the proposed research is to determine if Cl Therapy can be used with therapeutic success for increasing the amount of real work extremity use in patients with chronic stroke who have a greater level of motor impairment than those previously worked with in this laboratory (i.e., patients who are approximately in the next to lowest quartile of motor functioning). Another aim is to ascertain whether the locus of the lesion and its size as determined by MRI, are factors influencing the extent to which motor function can be recovered through the use of CI Therapy. This prospective, 4-year randomized trial, including 18-month follow-up will use a crossover design. Eight patients with chronic stroke from the next to lowest quartile of motor functioning will be randomly assigned to receive either Cl therapy (40 subjects) or a General Fitness placebo control intervention (40 subjects). Two years after intake the control patients will be crossed over to receive Cl Therapy. Primary outcome measures will be a laboratory motor function test and amount of extremity use in the real world setting. Changes in psychosocial functioning will also be measured. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: ADULT ATTACHMENT AND INTERVENTION EFFICACY WITH PRETERMS Principal Investigator & Institution: Teti, Douglas M.; Professor; Psychology; University of Maryland Balt Co Campus Baltimore, Md 21250 Timing: Fiscal Year 2002; Project Start 01-AUG-2001; Project End 31-MAY-2003 Summary: (provided by applicant): Premature birth is a major cause of developmental delay, and the need remains for cost effective, replicable methods to promote

Studies 7 development in preterm children. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree. This randomized clinical trial aims to 1) evaluate the efficacy of an integrated, replicable intervention designed to facilitate parent-infant interaction, infant physical development, mental and motor development, and socioemotional development in a group of infants at medical and environmental risk for developmental delay; and 2) explore the role of mothers' and fathers' states of mind with regard to attachment and parents' commitment to the intervention, as moderators of intervention efficacy. The study will recruit 240 urban, single, African-American mothers and fathers of preterm (<37 weeks gestational age), low birthweight (< 2,500 grams at birth) infants admitted to the neonatal intensive care unit. Half of the families will be randomly assigned to an intervention group, and half to a control group. Both groups will be comparable with respect to race, maternal parity, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender. The intervention integrates a videotape about preterm infant competencies, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement, and parent-administered infant massage, beginning when infants are 32-to-36 weeks post-conceptual age (PCA) and terminating at 52-to-56 weeks PCA. Intervention efficacy, and the moderating roles of adult attachment and parental commitment to intervention, will be evaluated along dimensions of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first two years. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: AMELIORATING DISABILITY THROUGH POWER TRAINING Principal Investigator & Institution: Bean, Jonathan; Spaulding Rehabilitation Hospital 125 Nashua St Boston, Ma 02114 Timing: Fiscal Year 2003; Project Start 30-SEP-2003; Project End 31-AUG-2007 Summary: (provided by applicant): Limitations in mobility affect almost one in 4 individuals over 65 and have been demonstrated to be predictive of disability and institutionalization. In those most limited, muscular power, the ability to perform muscular work per unit time, is closely associated with the functional tasks that predict disability. Muscular power is a separate attribute from strength declining more precipitously in late life. The preservation of muscular power in late life has been recently identified as high priority for gerontological research. The candidate in this application is a physiatrist, a clinician researcher with a Masters in Exercise Physiology, who specializes in geriatric rehabilitation. It is the applicant's goal to evaluate the influence of eight Vest Exercise a form of muscle power training (MPT) on functional loss in mobility limited elders. Through pilot studies in elders with mobility limitations, the applicant and his collaborators have demonstrated the close relationship between lower extremity muscular power and important tasks of functional performance. Additionally, pilot studies have shown that MPT is not only safe, but also more potent than strength training at correcting lower extremity motor impairments. Lastly, the applicant is investigating the potential of Weighted Vest Exercise, having preliminary results demonstrating its effectiveness. This award is framed around the following activities: 1) conducting a pilot intervention trial utilizing weighted vest exercise, a potential home-based type of MPT in elders with significant mobility limitations; 2) enhance my career development plan through continued involvement as co-investigator in an RO1 studying closely related issues; 3) completing studies in clinical trial methodology and utilizing these previous experiences as the basis for a randomized

8 Physical Therapy controlled trial, that is appropriately powered to evaluate the influence of non-machine based MPT on all disablement outcomes, including disability; and 4) develop the skills, expertise and experience to become a successful independent clinician scientist within the field of geriatric rehabilitation. This proposal contains a strong environment and mentorship plan containing leading institutions and individuals from the fields of Aging and Rehabilitation. It will provide important insights into exercise's role in preserving late life functioning. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: AMPHETAMINE ENHANCED STROKE RECOVERY--BURKE SRCI GROUP Principal Investigator & Institution: Goldstein, Larry B.; Professor Medicine; Medicine; Duke University Durham, Nc 27706 Timing: Fiscal Year 2001; Project Start 30-SEP-2000; Project End 30-JUN-2003 Summary: This is a \"Pilot Grant\" which proposes to collect preliminary data in order to help in the design of a full scale clinical trail testing the efficacy of amphetamine in conjunction with physical therapy to facilitate motor recovery after stroke. This clinical study will incorporate five sites including, Duke University, Burke Rehabilitation Hospital, Helen Hayes Hospital, Wake Forest University and Washington University. Under the direction of Dr. Goldstein, this pilot proposal is designed to refine the amphetamine-physical therapy as well as the targeted patient population. In addition, the proposed work will help in the estimation for appropriate sample size, refine outcome measures, monitoring techniques, patient protocols and data management procedures. Finally, the completion of this pilot study would result in data addressing the efficacy of this treatment strategy. Patients will be randomized for either amphetamine or placebo during 10-30 days after stroke. The initial design will incorporate a treatment of 10-mg d-amphetamine or placebo combined with a one-hour physical therapy session beginning one hour after drug/placebo administration every 4 days for a total of 6 sessions. Analyzing the first 65 patients, a second cohort of patients will then be entered into a different regimen depending on whether the first regimen suggests a benefit of this combined therapy. If the data are supported, the second regiment will consist of 10 mg of d-amphetamine or placebo combined with a one-hour physical therapy session as in the first regimen, but the interval between treatments will be decreased to very 2 days. If the initial data is not supportive, the second regimen will consist of treatments with 10 mg of d-amphetamine or placebo combined with a one- hour physical therapy session beginning one hour after drug/placebo administration every 4 days. However the treatment duration will be increased to a total of 10 sessions. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: BODY WEIGHT SUPPORTED AMBULATION TRAINING AFTER SCI Principal Investigator & Institution: Calancie, Blair M.; Professor; Neurosurgery; Upstate Medical University Research Administration Syracuse, Ny 13210 Timing: Fiscal Year 2001; Project Start 01-AUG-2001; Project End 30-NOV-2004 Summary: Fundamental strategies first adopted in major centers 20 years ago for the physical rehabilitation of persons with sub-acute or chronic spinal cord injury (SCI) have changed little since that time. One novel method of gait rehabilitation involves the use of an overhead support point and a harness. This body weight support' (BWS) strategy has been combined with treadmill-based gait training in several centers throughout the world, with what are claimed to be dramatic results; we also have seen

Studies 9 marked improvement in function in our subjects trained in this manner from preliminary studies. It is speculated that this form of training may enhance output of a 'central pattern generator' of stepping movement from circuitry intrinsic to the subject's spinal cord. However, published studies of this type have been limited in their ability to form strong conclusions due to small sample size, inadequate control interventions, and/or limited outcome measures. In particular, only limited attention has been paid to the role that training-induced physical conditioning might play in mediating the functional improvements reported. This study will address these weaknesses to determine whether BWS-gait training is more effective than conventional rehabilitation therapy in improving functional gait in person's with neurologically-incomplete spinal cord injury. Two populations will be studied: persons with chronic SCI (greater than 1 year post-injury), and persons with sub-acute SCI (2 - 8 months post-injury). For the chronic SCI study, subjects will be randomly assigned to one of 3 groups: body weight support and treadmill-based training, body weight support and overground training, and conventional rehabilitation therapy. This design allows us to directly compare whether treadmill-based training, and its inherent advantage of providing highly- rhythmic input to the subject's legs, is superior to overground-based training, and its inherent advantage of allowing use of assistive devices, thereby replicating a more 'natural' training condition. Training sessions will typically last up to 1 hour/session, at a frequency of 3 sessions per week for a 13 week period. Persons with sub-acute injury will be randomized to receive either BWS-treadmill training, or conventional rehabilitation. All subjects will be evaluated with a battery of functional, metabolic and neurophysiologic measures prior to the onset of training, and during the week after training has been completed. The primary outcome measure will be average maximum overground walking velocity without body weight support but with the use of passive assistive devices. Secondary measures will concentrate on function (balance, mobility), fitness (work capacity, strength, gait efficiency), and spinal cord neurophysiology (motor conduction, reflex excitability). These studies will allow us to determine whether the functional improvements associated with BWS-based training are due to neurologic adaptation within the spinal cord, or reflect an increased work capacity secondary to fitness training; both possibilities have important implications with respect to optimizing therapy for persons with spinal cord injury. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: BRAIN AND BEHAVIOR CORRELATES OF ARM REHABILITATION Principal Investigator & Institution: Winstein, Carolee J.; Associate Professor; Biokinesiology & Phys Therapy; University of Southern California 2250 Alcazar Street, Csc-219 Los Angeles, Ca 90033 Timing: Fiscal Year 2002; Project Start 01-SEP-2002; Project End 30-JUN-2005 Summary: (provided by applicant): Of all impairments that result from brain stroke, perhaps the most serious and most needing of rehabilitation effectiveness studies is hemiparesis of the upper extremity. Overall, this proposal will use 3-D behavioral kinematics and MRI neuroimaging techniques to examine the motor control and cerebral activity changes associated with constraint-induced (CI) movement therapy for patients with sub-acute stroke who are between 3 and 6 months post stroke. This is a companion study to the previously funded multi-center randomized clinical trial (H D37606-01), Extremity Constraint-Induced Therapy Evaluation (EXCITE). This project complements EXCITE by probing the neurobiological and behavioral mechanisms underlying this clinical intervention in stroke rehabilitation. The specific aims are to: 1) determine the relationship between lesion size and location, residual hand capability,

10 Physical Therapy and responsiveness to CI therapy; 2) determine the effects of CI therapy on the motor control of reaching and grasping actions; 3) determine the effects of Cl therapy on the cortical sensorimotor neural network associated with the planning and execution of goal-directed wrist and grasping actions; and 4) determine the persistence and or stability of these changes in motor control, brain activity, and functional outcomes one year later as a consequence of Cl therapy. Expected changes in sensorimotor area activation (learning-dependent neural plasticity) and motor behavior associated with two weeks of intensive practice of the impaired upper extremity in combination with restraint of the less affected upper extremity in stroke patients (n = 14) who meet the EXCITE inclusion criteria will be determined by comparison with that of a delayed- intervention stroke group (n = 14) who will receive \"usual and customary\" care. This comparison will allow the direct effects of \"forced use\" to be exposed at both the neurobiological (brain activity) and behavioral (motor performance and function) levels while controlling for spontaneous recovery processes and those achieved through standard post-stroke physical rehabilitation methods. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: BUILDING LIFE SKILLS IN CHILDREN WITH CYSTIC FIBROSIS Principal Investigator & Institution: Christian, Becky J.; None; University of North Carolina Chapel Hill Office of Sponsored Research Chapel Hill, Nc 27599 Timing: Fiscal Year 2001; Project Start 01-MAR-1998; Project End 30-NOV-2002 Summary: (Adapted from the Investigator's Abstract): This project will test the effectiveness of an intervention to improve psychosocial adjustment and functional and physiologic health in children (8 to 12 years) with cystic fibrosis (CF) by teaching them life skills to manage their chronic illness in their everyday lives. The goal is to help children develop strategies for managing their health status and life experience to maximize their development progress and quality of life. It is hypothesized that at the end of treatment, children who receive the KIDS with CF -- Building Life Skills protocol will show significantly greater improvement in psychosocial adjustment (self-esteem and self-competence, loneliness, impact of illness), functional health (functional disability, treatment adherence), and physiologic health status (pulmonary function and physical growth) over time than those receiving usual CF care. A two-group experimental, repeated measures design will compare children who receive the intervention with those who receive usual care; 116 children will be randomly assigned to the experimental or control groups. Treatment will include social problem-solving training and social skills training delivered in individual and small group sessions over a 5-week time span with 1-week intervals between sessions. At each group session, FEV1, height, and weight will be measured and children will have a brief interview on medication use, performance of chest physical therapy, and physical activity. At baseline assessment, immediately after, and at 3-, 6-, and 9-months after the intervention, children will complete the Self-Perception Profile for Children, Loneliness in Children Scale, Perceived Illness Experience Scale, and Functional Disability Inventory; pulmonary function FEV1, height, and weight will be measured; and a brief interview focusing on medication use, performance of chest physical therapy, and level of physical activity will be conducted. Multivariate ANOVA will be used to compare the pre-intervention equivalence of the study groups. Repeated measures MANOVA will compare each psychosocial, functional, and physiologic health outcome variable for the intervention and control groups. Interview data will be analyzed using content analysis. This life skills intervention should also have applicability for children with other chronic illnesses.

Studies 11 Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: CAN EXERCISE TRAINING REVERSE PHYSICAL FRAILTY? Principal Investigator & Institution: Holloszy, John O.; Professor; Washington University Lindell and Skinker Blvd St. Louis, Mo 63130 Timing: Fiscal Year 2001 Summary: (Adapted from applicant's abstract). The major research focus of this OAIC is on the reduction of physical frailty resulting in a decrease in the risk of loss of independence and nursing home admission. The goals of this intervention study, IS-1, are: a) to determine the extent to which frail women and men over the age of 78 years can respond to exercise training with the cardiovascular, skeletal muscle, and central nervous system adaptations that have been shown to occur in younger individuals; and b) if significant adaptations do occur, to assess whether or not the magnitudes of these adaptations are sufficiently large and functionally important to result in improvements in performance of activities of daily living (ADL), instrumental ADL (IADL), advanced ADL (AADL) and in objective physical performance tests that correlate with the ability to perform IADL and AADL and are predictors of loss of independence, nursing home admission, and short- term mortality. The long-term goal is to obtain information that can be used to design practical, individualized programs of exercise that can be utilized in community settings to prevent or reverse physical frailty and maintain functional independence. The exercise training will have three phases consisting of 3 months of physical therapy exercises, 3 months of weight lifting superimposed on physical therapy exercises, and 3 months of aerobic exercise superimposed on physical therapy and weight lifting exercise. The aims of this research are to determine: a) the effectiveness of physical therapy exercises in improving flexibility, gait, balance, coordination, and strength and in reversing frailty; b) whether frail old people can adapt to weight lifting with significant increases in strength of all major muscle groups, whole body and skeletal muscle protein anabolism, and muscle mass, and a further reduction in frailty; c) whether frail old people can adapt to aerobic exercise training with increases in oxygen uptake capacity with a further decrease in frailty, and to evaluate the mechanisms involved in any increase in oxygen uptake capacity by determining maximal cardiac output, left ventricular stroke volume, and peripheral oxygen extraction; d) whether the exercise training decreases arterial stiffness; e) whether exercise training lowers blood pressure in subjects with mild hypertension; f) whether the exercise increases bone mineral density in the proximal femur, spine, and other regions of the skeleton; g) whether the exercise improves cognitive function and central processing speed; and h) whether the exercise improves quality of life. An important component of this research is to determine the extent to which the graduates from the program maintain improvements in functional capacity. Before discharge from the study, participants will be given individualized exercise prescriptions to follow at home and will be helped to put together home gyms or referred to a convenient exercise facility. Contact with the graduates will maintained by means of monthly phone calls and they will be brought back to the exercise facility once per month for a training session and periodic evaluations of functional capacity, using simple measures such as the standardized Physical Performance Test. Cost-effectiveness and cost-utility analysis will be used to evaluate the relative costs and benefits of the exercise. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

12 Physical Therapy • Project Title: CAN HRT AMELIORATE PHYSICAL FRAILTY IN OLD WOMEN? Principal Investigator & Institution: Kohrt, Wendy M.; Professor; Washington University Lindell and Skinker Blvd St. Louis, Mo 63130 Timing: Fiscal Year 2001 Summary: (Adapted from applicant's abstract). The major research focus of the OAIC is on the reduction of physical frailty resulting in a decrease in the risk of loss of independence and nursing home admission. The overall goals of this intervention study, IS-2, are to determine: whether 9 months of hormone replacement therapy (HRT) can bring about a reduction in frailty in physically frail women over 78 years of age; and whether exercise training results in greater improvements in functional capacity as reflected in strength, flexibility, balance, coordination, reaction time, aerobic power, and instrumental activities of daily living (IADL) and advanced ADL (AADL), as well as in muscle mass, cardiovascular function, and bone quantity and quality, in women who have been on HRT than in sex hormone-deficient women. Exercise training will begin after the women have been on HRT for 9 months, and will have three phases, consisting of 3 months of physical therapy exercises, 3 months of weight lifting superimposed on physical therapy exercises, and 3 months of aerobic exercise superimposed on physical therapy and weight lifting exercises. The first goal of IS-2 is to determine whether HRT can reduce frailty. The aims relative to this goal are to determine whether HRT can: a) increase skeletal muscle strength; b) increase capacity for aerobic exercise and improve cardiovascular function; c) increase bone quantity and quality; d) improve cognitive function and central processing speed; e) improve reaction time, balance, coordination, flexibility, and ability to perform IADL and AADL; f) decrease insulin resistance and improve glucose tolerance and plasma lipid and lipoprotein levels; and g) improve quality of life. Relative to the second goal, which is to determine if women who have adapted to 9 months of HRT have an enhanced adaptive response to the exercise program, the investigators will compare the magnitude of the adaptations to exercise plus HRT with the effect of HRT alone and with the effect of exercise alone in the women in IS-1. The specific aims relative to this goal are to determine whether HRT plus exercise is more effective than the exercise program alone or HRT alone in improving: a) flexibility, gait, balance, and coordination; b) strength of all major muscle groups, whole body and skeletal muscle protein anabolism, and muscle mass; c) oxygen uptake capacity; d) arterial elasticity; e) blood pressure in those with mild hypertension; f) bone mineral density in the proximal femur, spine, and other regions of the skeleton; g) cognitive function and central processing speed; and h) candidate of life. The plan is also to investigate mechanisms underlying any improvements in oxygen uptake capacity, muscle strength, blood pressure, and bone mass. Before discharge from the study, participants will be encouraged to continue HRT if there are no contraindications, and will be given individualized exercise prescriptions to follow at home. They will be helped to put together home gyms or referred to a convenient exercise facility. The investigative group will stay in contact with the graduates by means of monthly phone calls, and will bring them back to our exercise facility once per month for a training session and periodic evaluations of functional capacity using simple measures such as the standardized Physical Performance Test. Cost effectiveness and cost-utility analysis will be used to evaluate the relative costs and benefits of HRT and exercise. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

Studies 13 • Project Title: CLINICAL MEASURES TO LOWER GENITAL TRACT TRAUMA AT BIRTH Principal Investigator & Institution: Albers, Leah L.; None; University of New Mexico Albuquerque Controller's Office Albuquerque, Nm 87131 Timing: Fiscal Year 2002; Project Start 01-AUG-2001; Project End 30-APR-2005 Summary: (provided by applicant): Over 3 million women deliver vaginally each year in the United States, and most experience trauma to the genital tract with birth. This trauma can cause short and long term problems for new mothers, including pain and other functional impairments. Although lowering the rate of childbirth trauma would benefit many women, preventive measures have not been fully explicated. One factor, which may influence rates of childbirth trauma, is the hand maneuvers used by the birth attendant for perineal management late in the second stage of labor (the pushing or expulsive phase). Beyond limiting the routine use of episiotomies, no evidence supports any specific recommendations or perineal management immediately prior to vaginal birth. This study will assess the effects of techniques used by nurse-midwives on rates of spontaneous lacerations to the birth canal. A randomized trial of 1200 low-risk women will compare three strategies on the likelihood of an intact perineum after birth, with control for confounding variables (maternal age and parity, birth position, style of pushing, size and position of baby at birth, length of second stage, and epidural analgesia). The perineal care measures are 1) warm compresses to the perineum, 2) perineal massage with lubricants, and 3) no touching, that is hands off the perineum until crowning and expulsion of the baby. Patients will be recruited in six ambulatory clinics staffed by certified nurse midwives in Albuquerque, NM. Healthy gravidas at term will be randomized in labor. In second stage labor a staff midwife will perform one of the three-perineal management techniques (list above) prior to vaginal birth. After birth all perineal trauma will be documented by physical exam, and other clinical data recorded. Medical records will also be reviewed at hospital discharge and at the 4-6 weeks office visit to identify any complications/ adverse experiences. This study will identify whether any technique is superior for trauma reduction, and will generate evidence to inform the practice of all clinicians who work with childbearing women: nurses, nurse-midwives, family physicians, and obstetricians. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: COMBINATION THERAPY FOLLOWING SPINAL CORD INJURY Principal Investigator & Institution: Leasure, J L.; Salk Institute for Biological Studies 10010 N Torrey Pines Rd San Diego, Ca 92037 Timing: Fiscal Year 2001; Project Start 27-SEP-2001 Summary: Much recent research suggests that administration of neurotrophins to injured spinal neurons has beneficial effects on neuronal survival, and can even improve recovery of motor function. In addition, there is a wealth of past research indicating that physical therapy can improve motor function following central nervous system damage, even if such treatment is begun years after the initial injury. Indeed, rehabilitative interventions that target an impaired extremity have been shown to be highly effective in improving the range of ability of that affected limb. It is rare, however, that pharmacological treatment is combined with physical therapy measures, and the combination of neurotrophin administration and targeted physical rehabilitation has not been attempted. It is the goal of this proposal to combine these two strategies that have repeatedly been shown to improve neuroanatomical and behavioral recovery of function. Thus, administration of neurotrophins to the injured

14 Physical Therapy spinal cord will be combined simultaneously with physical rehabilitative measures both immediately after spinal cord injury, as well as during the chronic phase. The results may have clinical relevance, should either the acute or delayed combined approach prove efficacious in improving neuroanatomical outcome and restitution of motor function. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: CONSTRAINT THERAPY FOR HEMIPLEGIA AFTER PEDIATRIC TBI Principal Investigator & Institution: Michaud, Linda J.; Associate Professor; Children's Hospital Med Ctr (Cincinnati) 3333 Burnet Ave Cincinnati, Oh 45229 Timing: Fiscal Year 2001; Project Start 24-SEP-2001; Project End 31-AUG-2003 Summary: (provided by applicant): Traumatic brain injury (TBI) is the most common cause of acquired disability in childhood. Children with impairment following moderate to severe injury subsequently show negligible rates of change in motor function after one year. Adults with chronic stroke have demonstrated improvement in motor function years following insult with constraint-induced movement therapy (CI therapy). Neuroimaging correlates of recovered function in adult hemiplegic extremities reveal differences in cortical activation patterns in comparison with normal patterns The objective of this proposal is to organize a research team that will develop a clinical trial of CI therapy in children with hemiplegia persisting more than one year following TBI. The study proposed for development would be prospective, randomized, crossover, and single-blinded, to test the major hypotheses: 1) that changes in motor function in hemiplegic extremities occur at a higher rate, to a greater extent, and with more qualitative improvement following CI therapy, in comparison to traditional physical and occupational therapy and 2) that improvement following CI therapy is accompanied by discernable differences in patterns of cortical activation on functional magnetic resonance imaging. While the emphasis is intended to be focused on forced use of the upper extremity in developing the study, consideration will also be given to developing a component of forced weight shift for the lower extremity. The planning process would include development of the protocols, selection of outcome measures, and methods of statistical analyses. Individual rate-of-change modeling will explored for inclusion in the statistical methods. Additional brain mapping correlates of changes in functional motor activity will be considered for inclusion in the clinical trial, including transcranial magnetic stimulation paradigms. Lessons learned from designing an innovative study to evaluate the effectiveness of rehabilitative intervention in improving motor function after pediatric TBI and the accompanying changes in cortical reorganization may be generalizable to studies of interventions directed toward other domains of dysfunction and in other study populations. Functional MRI offers clear potential to increase our understanding between rehabilitation efforts, functional recovery, and neurological reorganization in ways that could direct the design of future interventions in pediatric rehabilitation. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: CORE--FUNCTIONAL ASSESSMENT Principal Investigator & Institution: Brown, Marybeth; Associate Professor; Washington University Lindell and Skinker Blvd St. Louis, Mo 63130 Timing: Fiscal Year 2001 Summary: (Adapted from applicant's abstract). The major function of this Core (RRC-B) is to support the research of the two intervention studies in this OAIC, as well as that of

Studies 15 pilot studies supported by the OAIC. A second important function of RRC-B is to train young investigators in geriatrics and gerontology who are interested in research relevant to maintenance of functional independence of the elderly, in the performance of the procedures available within the RRC- B. To the extent that the investigators' time and the resources of the RRC-B permit, the RRC-B will also support other pilot and preliminary studies as well as funded studies in geriatrics and gerontology. Use of the Core will be prioritized on the basis of the relevance of the research to the goal of this OAIC, which is to find effective means of preventing and reversing physical frailty and maintaining functional independence of the elderly. A specific function of RRC-B is to quantitatively assess physical performance capabilities and degree of physical frailty. This will include a physical performance test that correlates with degree of physical frailty and predict loss of independence and nursing home admission, as well as evaluation of range- of-motion, balance, gait, coordination, speed-of-movement, and strength. Another function of RRC-B is to apply physical therapy expertise to the initial evaluation of the volunteers to assist in identifying the functional impairments (e.g., muscle weakness, limited range-of-motion, poor balance, etc.) responsible for the frailty, and any pathological processes (e.g., arthritis, other orthopedic problems, decreased proprioception, etc.) underlying the functional impairments. A third function is to train young investigators in geriatrics and gerontology who are interested in research relevant to maintenance of functional independence of the elderly, in the performance of the functional assessments in RRC-B. This will provide an opportunity for junior faculty, research associates, and master and doctoral students in physical therapy, occupational therapy, exercise science, and other disciplines to gain expertise in the functional assessments of frail elderly that are applicable to their own research in areas relating to maintenance of independence of older people. Performing the functional assessments in RRC-B instead of in each of the intervention studies is intended to increase efficiency by eliminating the need to have personnel trained in the performance of the procedures in each of the studies and by eliminating the need to duplicate equipment. Furthermore, having all the assessments performed by the same physical therapist will enhance data quality by decreasing data variability. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: CUSTOMIZED ELECTRICAL STIMULATION FOR SCI REHABILITATION Principal Investigator & Institution: Hartman, Eric C.; President; Customkynetics, Inc. Versailles, Ky 40383 Timing: Fiscal Year 2002; Project Start 13-SEP-2002; Project End 31-AUG-2004 Summary: (provided by applicant): Exercise for people with SCI can enhance physical fitness and slow secondary complications of SCI. Unfortunately, available exercise equipment is expensive and provides marginal benefits. In this Phase II project, we will continue to develop and evaluate an exercise system for individuals with SCI seeking to improve their physical fitness and/or enable use of a functional electrical stimulation system for standing. The device uses electrical stimulation of lower-extremity musculature to generate a coupled hip/knee bending motion that moves the upper body against gravity. It provides the ability to perform strength and endurance training exercises in a manner that provides graded loading of the lower extremities. It consists of mechanical frame and a multi-channel stimulator with an adaptive controller to generate the desired movement and GRF profiles. The Phase I project demonstrated feasibility by developing a prototype, evaluating it in experiments on human subjects with SCl, and identifying its limitations.The Phase II goals are to move towards Phase Ill

16 Physical Therapy commercialization by:1. Designing and developing an improved device; 2. Evaluating the ability to provide substantial exercise benefits in a clinical setting; 3. Characterizing the biomechanics of the exercise; and 4. Interfacing the device with an implanted electrical stimulation system. 3. characterizing the biomechanics of the exercise; and 4. interfacing the device with an implanted electrical stimulation system. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: DETERMINANTS OF RECOVERY FROM HIP FRACTURE (BONE/MUSCLE) Principal Investigator & Institution: Magaziner, Jay S.; Professor; Epidemiology and Prev Medicine; University of Maryland Balt Prof School Baltimore, Md 21201 Timing: Fiscal Year 2001; Project Start 01-JUL-1992; Project End 30-JUN-2002 Summary: Hip fracture represents a major health problem facing the aged; 18-27% die in the year after fracture, and as many as 40% do not return to pre- fracture levels in functional domains involving lower extremities. Changes in bone mineral density (BMD) and muscle mass and strength which are expected to follow the immobility of hip fracture are thought to be key factors in subsequent falls, fractures and disability. The primary aim of the proposed study is to describe the changes in BMD during the year following hip fracture, and to identify potentially modifiable determinants of this change. The potentially modifiable factors of major interest include: time of weight bearing relative to the fracture, timing and intensity and post-fracture and the association between functional recovery in lower extremities and post-fracture changes in BMD and muscle mass and strength. These issues will be addressed through a prospective study of community- dwelling white women, aged 65 and older, entering Union Memorial Hospital with a fresh hip fracture (N-250). BMD and muscle mass and strength will be measured at 3, 10, 60, 180 and 360 days post-fracture. Information on pre-fracture health, functional status and activity level will be obtained. Ambulatory status, physical therapy, functioning/ activity level, medical events, and falls will be monitored for one year. Data will be analyzed using multivariate techniques designed to assess the impact of prefracture functioning/activity level, time to weight bearing, and commencement, duration and frequency of physical therapy on short-and long-term changes in BMD and muscle mass and strength post-fracture. In addition, the effect of changes in BMD and muscle mass and strength on the risk of falling post-fracture will be examined. Analyses will also evaluate the relationship between post-fracture changes in bone and muscle and lower extremity functioning during the post-fracture year. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: DEVELOPMENT OF A MASSED PRACTICE STROKE THERAPY DEVICE Principal Investigator & Institution: Koeneman, James B.; Kinetic Muscles, Inc. 1949 E Broadway Rd Tempe, Az 85282 Timing: Fiscal Year 2003; Project Start 01-MAY-2003; Project End 30-APR-2004 Summary: (provided by applicant): Stroke (CVA) is the leading cause of disability in the United States and it is estimated that its prevalence will more than double over the next 50 years. Current stroke therapy is labor-intensive and costly. The United States spends $17 billion taking care of stroke survivors. Recently, concentrated, massed practice therapies have been developed that improve function in CVA patients by reversing the effects of \"learned nonuse.\" The objective of this project is to investigate the feasibility of a device that facilitates the administration of massed practice stroke therapy. The long-

Studies 17 term objective is to provide a lightweight device for home use that provides motion and biofeedback of desired and undesirable muscle activity. Software controls the function of the device and monitors patient progress and compliance. A pneumatic artificial muscle will be used to provide physical motion. This artificial muscle has many of the properties of human muscle. It is lightweight, flexible and has spring like properties. This project will focuses on treating wrist and finger extensor weakness, however, the concept applies to all areas affected by motor impairment. This Phase I study includes detailed design verification measurements on the device and measures the responses of able bodied test subjects to the treatment protocol. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: DEVELOPMENT OF THE GAMECYCLE EXERCISE SYSTEM Principal Investigator & Institution: Boninger, Ronald M.; Three Rivers Holdings, Llc 1826 W Broadway Rd, Ste 43 Mesa, Az 85202 Timing: Fiscal Year 2003; Project Start 15-MAY-2001; Project End 31-AUG-2005 Summary: (provided by applicant): 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. 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 Phase I, lab testing demonstrated that the GAMECycle allows 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. In Phase II, we will further refine the design of the GAMECycle by 1) improving the stability of the system to minimize vibrations even when exercising vigorously, 2) maximizing the user's capabilities within the videogame context and expanding the variety of videogames with which the system is compatible, 3) enhancing the extent to which the system can be modified to meet the needs of the user, and 4) readying the system for commercial production. We will also place the refined prototype in rehab facilities and in the homes of end-users for a four-month trial for more extensive testing and evaluation of the GAMECycle, as compared with a standard arm-ergometer. The design improvements coupled with extensive off-site testing will insure the commercial viability of the GAMECycle, both as a product for individual in-home use, and as a product for institutions interested in better meeting the needs of their clients. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: DRUG-ENHANCED REHABILITATION IN RECOVERY FROM STROKE Principal Investigator & Institution: Wolf, William A.; Chicago Assn for Research & Educ in Sci Education in Science Hines, Il 60141 Timing: Fiscal Year 2003; Project Start 25-SEP-2003; Project End 31-JUL-2008 Summary: (provided by applicant): Stroke occurs in 600,000 U.S. citizens every year and is the leading cause of neurologic disability worldwide. Most stroke victims are left with permanent sensorimotor deficits as the result of ischemia-induced brain damage. Physical therapy (PT) remains the primary strategy to improve recovery, but there is a clear need to improve rehabilitation strategies. Promising investigational studies indicate that the stimulant drug amphetamine (AMPH) can enhance the rate and extent of sensorimotor recovery when paired with PT (AMPH/PT). However, AMPH adjunct

18 Physical Therapy therapy remains investigational due to concerns over its side effect profile and addiction potential. Alternatives are not available because there is little understanding of the mechanism underlying the clinical benefits of AMPH. The objective of this application is to understand the pharmacology and neurobiological mechanisms underlying AMPH enhancement of PT-aided sensorirnotor recovery following stroke. Our preliminary data indicate that AMPH/PT following brain damage leads to improved motor recovery that is associated with enhanced neurite outgrowth from corticomotor cells. We also demonstrate that AMPH activates cAMP response element binding protein (CREB), a transcription factor involved in neural plasticity and neurite outgrowth via growth factor activation. We will test the hypothesis that AMPH enhances sensorimotor recovery through specific receptor activation that leads to neurite outgrowth and formation of new motor pathways. Aims I and I! will focus on the pharmacology of AMPH. In Aim I we will establish the role of noradrenergic alphal and dopaminergic D1 and D2 receptors in mediating AMPH-enhanced sensorimotor recovery in rats that have received permanent middle cerebral artery occlusion. Motor recovery will be assessed using a battery of sensorimotor tasks. In Aim II we will ascertain whether selective stimulation of alphal, D1 or D2 receptors can emulate AMPH enhancement of sensorimotor recovery. Aim III will establish that recovery of function is associated with neurite outgrowth and determine the origin of this new growth. Aim IV will focus on key signaling molecules modulated by AMPH and which are critical mediators of neuronal plasticity. First, we will determine that drug-enhanced motor recovery is associated with activation of CREB in corticomotor cells. Next we will establish a role for basic fibroblast growth factor in mediating AMPH enhanced recovery of function as well as neurite outgrowth. From Aims I and II we will identify potential drug candidates that can rapidly translate into clinical use. From Aims III and IV we will identify potential targets for future therapy. Together our findings will lead to optimization of pharmacological approaches to enhance functional recovery after stroke. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: DURATION AND TIMING OF SUPPORTED TREADMILL TRAINING Principal Investigator & Institution: Duncan, Pamela W.; Professor; Health Services Administration; University of Florida Gainesville, Fl 32611 Timing: Fiscal Year 2002; Project Start 26-SEP-2002; Project End 31-AUG-2004 Summary: (provided by applicant): Body-weight supported treadmill training (BWSTT) is one therapeutic modality for locomotor training that is rapidly being adopted into physical rehabilitation to improve walking after stroke. While there is preliminary support for the efficacy of this therapeutic modality, the optimal intensity, frequency, and duration for this intervention is not known. There is lack of evidence concerning when delivery of this intervention is most effective post-stroke (e.g. sub-acute: 6 months post-stroke). The primary aim of this clinical trial planning grant is to organize an effective research team and develop the elements essential for conducting a successful randomized clinical trial (RCT) of BWSTT in individuals post-stroke. The proposed clinical trial of BWSTT will be designed to assess: (1) the optimal treatment duration (12 vs. 24 training sessions), (2) the timing of treatment delivery (1 - 3 months post-stroke vs. > 6 months post-stroke), and (3) the effects of severity of locomotor impairments. There are many essential components for the successful implementation of this RCT. Specifically, this planning grant will (1) identify additional collaborators, (2) develop (a) the experimental design and (b) the intervention protocols, (3) select and establish protocols for assessing the primary and secondary outcome measures, (4a) determine

Studies 19 the effect size and power needed for clinically meaningful results and (4b) establish an analysis plan, (5) develop a data coordination/management team, (6) assess the feasibility of subject recruitment strategies, (7) select exclusion and inclusion criteria, (8) develop methods to characterize competing interventions, (9) develop a training program to assure that the intervention is replicable across sites, (10) select sites for the RCT and attain Institutional Review Board approval, and (11) develop administrative operations to manage the RCT. The clinical trial planning grant will result in an organized and well-prepared research team ready to conduct an effective RCT of duration and timing of BWSTT and the effect of severity of locomotor impairment on outcomes. The long-term objective is to improve the ability to walk in individuals following stroke by providing clinical practice guidelines, based on scientific evidence, for the optimal use of BWSTT in rehabilitation. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: EFFICACY OF ACUPUNCTURE WITH PT FOR KNEE OSTEO- ARTHRITIS Principal Investigator & Institution: Farrar, John T.; Senior Scholar; Biostatistics and Epidemiology; University of Pennsylvania 3451 Walnut Street Philadelphia, Pa 19104 Timing: Fiscal Year 2001; Project Start 15-JUL-2001; Project End 31-MAR-2006 Summary: Acupuncture is an ancient Chinese technique of using a fine needle to stimulate points along theoretical meridians of energy to correct imbalances thought to be responsible for specific disease states. In the United States, acupuncture is often used for the treatment of painful conditions. The 1997 NIH Consensus Conference concluded that there was adequate evidence of efficacy in an acute dental pain model and in nausea. In chronic pain, most studies were too small, poorly designed, poorly executed, or improperly controlled to adequately demonstrate that needle acupuncture worked better than sham acupuncture, placebo, standard medical therapy, or even no treatment. Osteoarthritis (OA) of the knee has been proposed as a good model to test the efficacy of acupuncture in a chronic pain condition because it is an extremely common, well defined, and disabling condition with well established outcome measures for symptoms and functional status. There is clinical trial evidence of efficacy for the standard treatments of acetaminophen and NSAIDs, and exercise physical therapy (EPT), which is usually added when the patient develops functional limitations. One high quality study of acupuncture for knee OA, demonstrated moderate benefit in an unblinded comparison to a usual care control group. As such, a major question remains about whether acupuncture, used in addition to exercise therapy, will provide a clinically meaningful improvement in pain and function. Since pain can be the primary limiting factor in improved exercise capacity, if acupuncture has any efficacy in reducing the pain of knee OA, then the combination with an EPT program should be substantially more effective than EPT alone. Another major concern is that the effect of the acupuncture may be predominantly mediated by non- specific placebo effects rather than the specific effects of the placement of a needle. Another important component of this proposal is our use of a validated blinded placebo needle instead of sham acupuncture points. Therefore, the primary goal of this proposal is to use a properly designed randomized blinded clinical trial, using American College of Rheumatology (ACR) criteria and Food and Drug Administration (FDA) recommended outcome measures, to determine whether the addition of acupuncture to standard EPT provides an overall clinically important benefit to patients with symptomatic knee OA compared to placebo acupuncture. As a secondary goal, we will use the clinical trial data to develop prognostic and etiologic models for the patients that are most likely to respond

20 Physical Therapy to acupuncture. If a clinically important benefit for acupuncture is found, a broader application of this technique would be justified. However, if the results are negative, then the addition of acupuncture to EPT should be generally curtailed. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: ELECTROSTIMULATION FOR HEMIPLEGIA Principal Investigator & Institution: Chae, John; Associate Professor and Director of Rese; Medicine; Case Western Reserve University 10900 Euclid Ave Cleveland, Oh 44106 Timing: Fiscal Year 2001; Project Start 04-MAY-2001; Project End 30-APR-2005 Summary: (Verbatim from the application) Stroke is the most common serious neurological disorder in the United States and its incidence doubles with each decade after the age of 55. Hemiplegia is a striking manifestation of stroke and contributes significantly to the physical disability and impaired quality of life of stroke survivors. The evolving scientific data suggest that active repetitive movement of the hemiparetic limb is effective in facilitating the motor recovery of stroke survivors. However, present rehabilitation strategies emphasize compensatory training of the unimpaired extremity to maximize function, and prevention of complications of immobility. The broad goal or this project is to develop strategies to facilitate the motor recovery of stroke survivors, and thereby maximize. their function and quality of life. Previous studies have suggested that repetitive exercises facilitated by electromyogram (EMG) controlled neuromuscular electrical stimulation (NMES) enhance the upper extremity motor recovery of stroke survivors. However, these early studies were poorly controlled, sample sizes were small, long-term follow up were absent and outcomes were limited to motor impairments only. The aim of this project is to assess the tong-term effect of EMG-controlled NMES on the motor impairment and physical disability of chronic stroke survivors. This study complements an approved project that investigates the short-term effect of EMG-controlled NMES on neurophysiologic measures of central motor function. A stratified randomized clinical trial design will be utilized. This study will demonstrate that EMG-controlled neuromuscular stimulation enhances the upper extremity motor and functional recovery of chronic stroke survivors. The proposed intervention may be effective for acute stroke survivors and for persons with other forms of central nervous system motor dysfunction such as traumatic brain injury, cerebral palsy, multiple sclerosis and incomplete spinal cord injury. EMG-controlled NIMES may also be effective for lower extremity motor and functional recovery. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: ENHANCING RECOVERY OF SENSATION AFTER CEREBRAL ISCHEMIA Principal Investigator & Institution: Hoffman, John R.; Biology; Arcadia University 450 S Easton Rd Glenside, Pa 19038 Timing: Fiscal Year 2003; Project Start 01-SEP-2003; Project End 30-JUN-2006 Summary: There is sufficient evidence to demonstrate the capacity for reorganization of the mature mammalian cerebral cortex as a function of experience following brain injury. The use of physical and pharmacological interventions has been used to alter the post-infarct behavioral experience of animals following cortical lesions, and anatomical and functional recovery has been analyzed primarily within motor systems. The mystacial vibrissae of the rat, with their corresponding representation in the somatosensory cortex, provides an ideal vehicle for studies dealing with damage and subsequent recovery in the central nervous system. We have developed a surgical model

Studies 21 that results in ischemic damage confined to the posteriomedial barrel subfield (PBMSF) of the first somatosensory cortex of the rat. Damage to the PBMSF results in a loss of tactile discrimination using the mystacial vibrissae. The recovery of sensory function can be examined using a gap crossing test in which animals discriminate between two textures. Preliminary data obtained using this model indicates that early physical intervention in the form of short bouts of whisker stimulation results in a dramatic acceleration in the rate of functional recovery in this sensory system. This project is designed to determine an optimal rehabilitation paradigm for the recovery of sensory function following ischemic injury to the cerebral cortex of the rat. The focus of this research will be to examine factors that optimize functional recovery and maximize the anatomical and physiological reorganization of the central nervous system (CNS) following central lesions. By examining the effect of types, duration and intensity of intervention on the behavioral and anatomical data from the same animal, we will provide important information regarding 1) an optimal mode of intervention; 2) how different modes of training maximize or limit CNS plasticity; and 3) the global functional activity pattern throughout the central neuraxis and the \"path\" of effective connectivity along that neuraxis. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: EVIDENCE-BASED GERIATRIC PT CONFERENCE Principal Investigator & Institution: Wong, Rita A.; Physical Therapy; Marymount College of Virginia 2807 N Glebe Rd Arlington, Va 22207 Timing: Fiscal Year 2001; Project Start 01-FEB-2001; Project End 31-MAR-2002 Summary: Physical therapists provide primary, secondary, and tertiary health care and wellness services to individuals with impairments, functional limitations, and disabilities related to movement dysfunction. The purpose of this conference is to formulate an action plan to develop, assess, disseminate, and foster the appropriate utilization of scientific evidence to enhance patient care and improve the physical therapy outcomes of older patients. Existing models for clinical scholarship will be critiqued, a vision and plan for the future developed, and an assessment and dissemination plan implemented. Specific conference goals are to 1) guide the development of more efficient and effective ways to access and incorporate new evidence into geriatric rehabilitation and wellness practice, 2) enhance the commitment to, and perceived value of, evidence-based decision-making in physical therapy clinical settings, and 3) provide a model for formulating a best-practice plan-of-action that can be used across practice settings. The two-day conference will include formal present6ations panel discussions, and small workgroup activities. Speakers will include leaders in evidence-based clinical decision making, educational methodology, geriatric physical therapy, information technology, and health care delivery systems. Conference participants include geriatrically-focused physical therapy educators, clinical service delivery managers, clinical outcomes researchers, and physical therapy clinicians. Conference products will be widely disseminated. Expected products include 1) formal conference proceedings with a specified action plan, 2) examples of model programs for evidence-based clinical-decision making, 3) a list of key focus areas for the development of evidence-based literature in geriatric physical therapy, and 4) recommendations for user-friendly and effective websites for geriatric rehabilitation and wellness evidence. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

22 Physical Therapy • Project Title: EXERCISE/TRAINING IN CHILDREN WITH HEART DISEASE Principal Investigator & Institution: Chang, Ruey-Kang R.; Medical Doctor; Harbor-Ucla Research & Educ Inst 1124 W Carson St Torrance, Ca 90502 Timing: Fiscal Year 2002; Project Start 15-MAY-2002; Project End 31-DEC-2002 Summary: (provided by applicant): The principal investigator will develop expertise in exercise testing and training of children and obtain the experience and skill necessary to initiate independent research projects during the award period. The principal investigator's long-term career goal as an academic pediatric cardiologist is to become a clinical investigator with a research focus in exercise physiology and cardiac rehabilitation. Exercise intolerance is an under-recognized chronic morbidity in children with heart disease. Poor exercise capacity leads to low self-esteem and poor quality of life. Children with single ventricle after the Fontan operation and children after orthotopic heart transplantation (OHT) are among children with the lowest exercise capacity. Whether exercise intolerance in these children is due to cardiopulmonary dysfunction or deconditioning from decreased physical activity remains unclear. The role of skeletal muscle and humoral responses in determining exercise capacity and the effect of exercise training in children with heart disease are unknown. They propose a prospective, randomized and controlled study to compare physical activity level of healthy children and children with Fontan or OHT, to evaluate the skeletal muscle, catecholamine and cytokines in relation to exercise capacity, and to determine the effect of exercise training on cardiopulmonary function, skeletal muscle and quality of life. In order to conduct this study, prepubertal children six to 13 years of age, including 40 children after Fontan, 40 children after OHT, and 40 healthy children will be recruited. Subjects will be randomized to a six-week endurance training program or computer workshops (no training). The project will be conducted over five years and training sessions will be held in the summer. The following tests will be performed before and immediately after exercise training is completed: lean body mass by dual energy X-ray absorptiometry (DEXA) scan, thigh muscle volume by magnetic resonance imaging (MRI), echocardiogram, pulmonary function test, cardiopulmonary exercise test, catecholamine and cytokine tumor necrosis factor (TNF)-alpha, IL-1beta, and IL-6 levels at rest and during exercise, physical activity level by activity monitor and quality of life measures by a questionnaire. They will compare these measurements between children with training and children without training and compare the effect of exercise training on children with Fontan, OHT and healthy children. The study is designed to define important mechanisms of exercise intolerance among children with severe forms of heart disease. The results of exercise training will provide evidence related to the physiologic and psychosocial benefits of increased physical activity and form the basis for future research on cardiopulmonary rehabilitation for children with heart disease. The principal investigator will take advanced courses to enhance knowledge and skills needed for patient-oriented research and work with the mentors to conduct the proposed project during the award period. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: FES AND BIOMECHANICS: TREATING MOVEMENT DISORDERS Principal Investigator & Institution: Buchanan, Thomas S.; Professor and Director; None; University of Delaware Newark, De 19716 Timing: Fiscal Year 2002; Project Start 07-AUG-2002; Project End 31-JUL-2007 Summary: (provided by applicant): This Biomedical Research Partnership project proposes to combine resources from professors of Mechanical Engineering and Physical

Studies 23 Therapy through our newly organized Center for Biomedical Engineering Research at the University of Delaware. The five-year goal of this project is to assist patients with CNS dysfunction to produce improved walking patterns through a combination of functional electrical stimulation (FES), robotic-assistive training and biomechanical modeling. In the first phase of this project, which is described in this proposal, the focus will be on individuals with stroke exhibiting hemiparetic leg impairment. The technique should be generalizable to a variety of neurological impairments. The movements for these individuals will be improved or \"optimized\" in four ways: Nonrisk Maximize postural stability, Injury Minimize musculoskeletal injury (e.g., arthritis) during movement, Cosmesis Develop a more natural looking gait, and Energy Minimize metabolic energy consumption during movement. The \"NICE\" optimization protocol will be realized through musculoskeletal modeling, robotic assistance, functional electrical stimulation, and neuromuscular training. The specific task we will study will be partial body weight suspension gait on a treadmill. The organization of this project has been divided into 3 distinct aims, which may be summarized as follows. Aim 1: Identify impairments in the locomotor patterns of the lower extremity in patients with hemiparetic stroke and create a paradigm to optimize the movement patterns (\"NICE\" optimization). This will be accomplished through biomechanical modeling using gait analysis and electromyographic data. Aim 2: Develop the methods and equipment (\"NICE\" rehabilitation system) necessary to implements the \"NICE\" optimization of locomotion in patients with stroke. We will achieve this through the use of a robotic device and an electrical stimulation system. Aim 3: Test the feasibility of the use of the \"NICE\" rehabilitation system in patients with hemiparetic stroke and make adjustments to the system based on the patient trials. Our ten-year goal is to produce a portable (wearable) FES system to assist patients with CNS dysfunction in the production of coordinated movements. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: FUNCTIONALLY BASED TREATMENT OF STRESS INCONTINENCE Principal Investigator & Institution: Borello-France, Diane F.; University of Pittsburgh at Pittsburgh 350 Thackeray Hall Pittsburgh, Pa 15260 Timing: Fiscal Year 2001 Summary: The long-term efficacy of pelvic floor exercise (PFE) as a treatment for urinary incontinence is threatened by patient compliance. To enhance compliance, PFE needs to be effective, while reducing the time burden placed on the patient. Our long- term objectives are to 1) validate a physiologically based, task-specific approach to PFE and 2) determine the exercise frequency needed to preserve muscle strength. Our specific aims are to determine: 1) the effectiveness of an individualized, physiologically based PFE regimen, 2) if a treatment progression to include exercise in upright postures is more effective than one performed in a lying position, and 3) if a low frequency exercise program is sufficient to preserve therapeutic gains over a six-month period. We will study 50 women, ages 40-70, with genuine stress incontinence. Based on symptom severity, we will randomly assign subjects to perform exercise either in upright postures or in a lying position. Subjects will attend 12 weekly physical therapy (PT) visits and perform a home exercise program (HEP) consisting of muscle strength, power, and endurance exercise. Using electromyography (an electrical recording of muscle activity), we will determine exercise progression using a protocol that individualizes exercise prescription based on muscle fatigue. At each weekly assessment, we will adjust the subject's HEP accordingly. Subjects assigned to the upright training group will perform one third of their exercises in the supine, sitting and standing positions. The other group

24 Physical Therapy will perform all exercises while in a lying position. At week 12, we will randomly assign subjects in each treatment group to either a low-(exercise once a week) or high-(exercises every other day) maintenance group. To determine treatment outcomes, we will compare group differences in the number of incontinent episodes, amount of urine lost during a psd test, a measure of urethral resistance (Valsalva leak point pressure), and scores on a quality of life measure. To determine the overall effectiveness of the treatment protocol, we will compare pre-to post-treatment changes in incontinent episodes to similar data reported in the literature. We will also examine the relationships between menopausal status, incontinence severity, and treatment outcomes. The results of this study may lead to a more effective exercise approach. Thus, future clients may benefit from fewer PT visits, greater pelvic muscle functions, and avoidance of surgery. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: HOW ACCESS AFFECTS OUTCOMES OF REHABILITATION SERVICES Principal Investigator & Institution: Iezzoni, Lisa L.; Associate Professor; Beth Israel Deaconess Medical Center St 1005 Boston, Ma 02215 Timing: Fiscal Year 2004; Project Start 01-JAN-2004; Project End 31-DEC-2005 Summary: (provided by applicant): With the aging population, the number of Americans with functional limitations will rise by over 300% by 2049 if the age-specific prevalence of major chronic conditions remains unchanged. While medical interventions can sometimes dramatically improve physical functioning, restoring functional abilities is unrealistic for many people. The focus shifts to preserving function, slowing its decline; and preventing secondary complications. Rehabilitation services, including physical therapy (PT) and occupational therapy (OT), are central to these efforts. Few studies have examined the outcomes of PT and OT as they are routinely practiced throughout communities in the United States. This project will use a longitudinal, nationwide survey of Medicare beneficiaries over and under age 65 (the 1 994-2001 Medicare Current Beneficiary Surveys), linked with respondents' Medicare claims, to examine outcomes of PT and OT. A major change in Medicare payment policy -- the 1997 Balanced Budget Act, which tightened payments for rehabilitation services -- will serve as a \"natural experiment\" of conditions under which access to routine rehabilitation care is constrained. The proposed study aims to examine the association between the intensity of PT and OT services and likelihood of good outcomes, including lower rates of: self-reported functional decline; worsening overall health; activities of daily living (ADL) and instrumental ADL dependence; institutionalization; acute care hospitalization; injury prompting medical attention; decubitus ulcer development; purchase of assistive technology; social isolation; and death. The study will examine persons within five conditions: arthritis; stroke; acute myocardial infarction; chronic obstructive pulmonary disease; and lower extremity mobility problems, regardless of cause. Two inter-related hypotheses will guide this work: (1) increased intensity of PT and OT is associated with better outcomes; and (2) decreased access to PT and OT is associated with worse outcomes. These hypotheses will be tested using cross-sectional and longitudinal analyses; analytic techniques will include time series, propensity score, instrumental variable, and proportional hazards regression modeling. The primary outcome of the proposed study will be an assessment of the association of PT and OT, as routinely practiced nationwide and important outcomes of care. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

Studies 25 • Project Title: HUMAN GENOME EDUCATION MODEL (HUGEM) PROJECT II Principal Investigator & Institution: Lapham, E V.; Pediatrics; Georgetown University Washington, Dc 20057 Timing: Fiscal Year 2001; Project Start 28-SEP-1993; Project End 31-OCT-2001 Summary: (Applicant's abstract) The field of medical genetics continues to witness dramatic advances (largely resulting from the Human Genome Project) which have led to an increased demand for genetic services and brought genetics issues to the forefront of health care. While physicians and nurses provide primary medical care for persons with genetic conditions, the allied health professionals (such as nutritionists, occupational therapists, physical therapists, psychologists, social workers, and speech- language pathologists) are often the first to: 1) suspect that their clients have a genetic disorder; 2) give a label to the developmental or behavioral symptoms; 3) recommend further evaluations including genetic testing 4) interpret and discuss results of testing and sometimes give diagnoses; 5) influence attitudes and decisions of their clients about participating in genetic testing or research; 6) provide referrals to other resources such as genetic counseling and genetic support groups; 7) provide counseling related to coping with and adjusting to a genetic condition; and, 9) educate the public about genetic conditions and ELSI issues. Allied health professionals, in general, remain inadequately informed in the area of human genetics and issues related to genetic knowledge, genetic testing, and genetic research. Building on the experiences and products of the Human Genome Education Model Project (1993-1997), Georgetown University Child Development Center-University Affiliated Program (UAP) (Dept. of Pediatrics) and the Alliance of Genetic Support Groups plan to use the collaborative (consumer and health professional) education model to educate allied health professionals through their respective national organizations (American Dietetic Association, American Occupational Therapy Association, American Physical Therapy Association, American Speech-- Language-Hearing Association, American Psychological Association, Council on Social Work Education, and National Association of Social Workers). The overall goal is to derive optimal benefit from development of the Human Genome Project for allied health professionals and the consumers they serve. The specific aims are: 1. to conduct surveys to assess needs, determine education priorities, and identify resources of the respective organizations; 2. to use information from the surveys to adapt the collaborative education model to educate and sensitize health professionals about genetics, the HGP and its ELSI issues and to implement education for national staff, practitioners, and educators; and 3) to evaluate each level of education and disseminate information about the project. HuGEM II is designed to be carried out over a three-year period. An advisory committee will provide expertise in medical genetics, ethics, law, consumer issues, social policy, and health education. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MASSAGE THERAPY FOR BREAST CANCER-RELATED LYMPHEDEMA Principal Investigator & Institution: Bernas, Michael J.; Surgery; University of Arizona P O Box 3308 Tucson, Az 857223308 Timing: Fiscal Year 2002; Project Start 30-SEP-2002; Project End 31-MAY-2004 Summary: (provided by applicant): Massage therapy [in the form of Manual Lymph Drainage (MLD)] is an integral component, with compression bandaging (CB), of Combined Physical Therapy (CPT), the international consensus-recommended optimal treatment for peripheral lymphedema (LE). According to the World Health

26 Physical Therapy Organization, LE afflicts hundreds of millions worldwide (most from parasitic filarial infestation) and probably millions in the United States (most from operative and irradiation treatment of cancer). For more than a century, close links between various forms of massage and salutary effects on lymph circulation have been postulated but the efficacy of MLD alone without CB remains to be convincingly demonstrated. New experimental data derived from our NCCAMR21 funded investigation of a rat subacute LE model mimicking cancer-treatment related unilateral LE (radical groin lymphectomy/lymphadenectomy + irradiation) suggests that MLD alone reduces established LE volume as effectively as CB and CPT while minimizing LE development. As an initial translation of these experimental findings to patients and based on our retrospective clinical observations, we propose to examine prospectively the short-term and long-term efficacy of MLD alone compared to MLD + CB as part of CPT in a randomized trial in patients with mild (5-20% increase in arm volume) breast cancer treatment-related LE using and further developing both objective (serial arm LE volume reduction and lymphatic tracer transport enhancement using minimally invasive lymphangioscintigraphy) and standardized subjective/qualitative outcome measures (improved quality of life/compliance/cost-benefit scores). This initial study should lay the groundwork and evidence-based rationale for the design and implementation of expanded prospective randomized clinical trials of MLD alone in various types and stages of upper and lower extremity LE in children and adults. This combined experimental and clinical translational approach should thereby shed light not only on the physiologic mechanisms underlying massage therapy but also have potentially substantial impact on simpler cost-effective LE treatment alternatives worldwide. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MASSAGE THERAPY FOR CANCER-RELATED FATIGUE Principal Investigator & Institution: Avins, Andrew L.; Assistant Clinical Professor; Medicine; University of California San Francisco 500 Parnassus Ave San Francisco, Ca 94122 Timing: Fiscal Year 2001; Project Start 01-MAR-2001; Project End 31-DEC-2002 Summary: (APPLICANT'S ABSTRACT): The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non- invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being. The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Sixty patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. In addition to obtaining estimates of efficacy, this Exploratory/Developmental Research Grant (R21) application also proposes several research design innovations to address critical methodological issues that have plagued prior studies of complementary and alternative medicine (CAM) interventions in general, and bodywork therapies, in particular. 1) Current quantitative assessment tools often fail to fully capture the nature and degree of change

Studies 27 in highly subjective conditions and their impact on an individual's functioning and quality of life. We propose to add a novel qualitative research component to study changes in participants' perceptions of fatigue severity and its impact on their lives. 2) Most prior studies in bodywork interventions have failed to adequately control for the non-specific effects of the time spent with a practitioner and physical contact between the provider and participant. We propose to test a unique control condition (in addition to a usual-care control arm) to account for these effects. 3) Prior studies of bodywork therapies have neglected important psychological and sociocultural factors associated with subjects' participation and outcomes. We will examine these issues within the qualitative research component. 4) Because bodywork involves close personal physical contact, gender issues may complicate the provision and success of massage therapy. We will study these effects using qualitative methods, as well as a stratified randomization of gender-concordant and gender-discordant pairs to examine outcomes. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MIEL: MEDITATION AND MASSAGE IN END OF LIFE Principal Investigator & Institution: Katz, David L.; Director of Medical Studies; Griffin Hospital 130 Division St Derby, Ct 06418 Timing: Fiscal Year 2001; Project Start 30-SEP-2001; Project End 31-AUG-2003 Summary: (provided by applicant): Despite considerable advances over recent years in palliative care, end of life care, and the assessment of quality of life (QoL), little work has specifically addressed means of improving overall quality at end of life. Attention to the spiritual aspect of QoL, notwithstanding increasingly widespread acknowledgement of its importance, has been especially limited. Interventions to improve quality at end of life are needed with particular urgency to address the needs of the large and growing population of patients with AIDS in the US, a group subject to bereavement at end of life often compounded by isolation and alienation. On the basis of prior literature, meditation, and specifically Metta meditation, is promising as an intervention uniquely suited to meet spiritual needs at end of life. Of note, while meditation has the potential to address spiritual needs, it does not necessarily compensate for the benefits of physical contact. Among patients with AIDS subject to a sense of physical isolation, the benefits of meditation could be blunted unless the need for physical contact is also addressed. Whether the benefits of meditation and physical contact such as massage are interchangeable, independent, additive, or even synergistic is as yet unknown. We therefore proposed a randomized, controlled, single-blind 2X2 factorial pilot study of Metta meditation, with and without massage, to determine the effects on QoL among late-stage patients with AIDS at an AIDS-dedicated skilled nursing facility in Connecticut. The Missoula-Vitas QoL survey, a validated instrument for end-of-life, will be used to measure the independent and interdependent effects of meditation and massage on QoL during, immediately post, and late post-intervention in subjects randomly assigned to each of 4 treatment conditions. The meditation intervention will consist of initial instruction by an expert in the technique, followed by self- administration with audiocassettes. A certified massage therapist will provide the massage intervention. The methods to be tested in the proposed study are inexpensive, and do not require specialized facilities, and thus offer the promise of widespread application if proved effective. By addressing high priority aspects of end of life care for patients with AIDS in a methodologically rigorous manner, the proposed pilot study has

28 Physical Therapy considerable potential to advance the standards of care for this large, growing, and particularly needful population. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MOLECULAR MECHANISMS IN GLYCOGEN STORAGE DISEASE TYPE III Principal Investigator & Institution: Kishnani, Priya S.; Duke University Durham, Nc 27706 Timing: Fiscal Year 2001 Summary: Purpose: The long term objectives of the proposed research is to obtain a more complete understanding of the phenotype of different forms of glycogen storage disease type III (GSD-III), to identify mutations responsible for the disease, to help predict the clinical outcome and develop a new treatment strategy for the disease. In type III glycogen storage disease there are patients with deficient debranching enzyme activity in both liver and muscle (IIIa) and patients with deficiency in the liver but not the muscle (IIIb) yet the enzyme is a monomeric protein and appears to be identical in all tissues. The disease is characterized by hepatomegaly and/or progressive myopathy for which there is currently no effective treatment. Patients with this disease vary remarkably, both clinically and enzymatically. Although liver symptoms improve with age, muscle symptoms, which are minimal in childhood, increase in the third or fourth decade of life. There is a remarkable clinical variability even within the subgroup of patients who develop myopathy/cardiomyopathy, with no way to accurately predict the progression of the disease at the present time. We have identified exon 3 mutations in GSDIIIb patients. We hypothesize that mutations in GSD IIIb patients will shed light in the tissue specific expression of the debrancher gene. The second aim is to delineate the phenotype and clinical course within subtypes of GSD III through liver, muscle and cardiac studies. We hypothesize that patients with GSD IIIb will not develop muscle disease. The third aim is to study the relationship between location and type pf mutations in GSD III patients to the subtype and clinical severity of the disease. We hypothesize that the clinical outcome can be predicted in part based on the molecular definition. The fourth aim is to test the feasibility of enzyme replacement therapy for the disease by treating type III GSD patient cells in vitro with acid alpha-glucosidase (GAA). Methods Identification and characterization of mutations in different forms of GSD III will be done by SSCP followed by DNA sequencing. To better delineate phenotype and clinical course of the disease within subtypes of GSD III, detailed studies are performed on liver ( liver function tests, abdominal CT). Muscle studies to assess muscle strength and detailed cardiac studies (Holter and Echo) are being performed on all subjects. We are exploring the relationship between location and type of mutations in GSD III to subtype the clinical severity of the disease. Results (12/97 TO 12/98) 7 patients, 5M:2F ( 3 1/2 years -64 years), have been evaluated on this protocol. Of these patients, 6 are Caucasian, and one is African-American. 6 patients have GSD IIIa and one GSDIIIb. No adverse or unusual reactions were noted. After detailed muscle testing by the physical therapist involved in the project, it was found that all 6 subjects with GSDIIIa had myopathy. Subtle changes which may not have been identified by routine muscle testing were identified in 2/6 patients by the method (muscle dynamometry) used by us. Physical therapy has been initiated. 3/6 patients were also found to be deficient in carnitine, (documented for first time in this disease) and have since been started on carnitine. No changes on 24-hour holter monitor were found in the 6 patients. Significance and Future Plans Information gained by analysis of the debrancher gene and clinical and molecular dissection of different subtypes of GSD III will provide

Studies 29 insight into patient phenotype, the molecular basis of the disease, functional domains for the multifunctional enzyme, and general mechanisms controlling tissue-specific gene expression. Experiments with enzyme replacement therapy in vitro represents the first step in an overall program to develop an effective treatment for type III. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MOTOR CONTROL DEFICIT IN LOW BACK PAIN: CAUSE OR EFFECT? Principal Investigator & Institution: Cholewicki, Jacek; Associate Professor; Orthopedics and Rehabilitation; Yale University 47 College Street, Suite 203 New Haven, Ct 065208047 Timing: Fiscal Year 2001; Project Start 01-MAY-2001; Project End 30-APR-2004 Summary: (Verbatim from application) Revised Application: Because the specific causes underlying low back pain LBP have not yet been identified, it continues to be a significant public health problem. Many of the factors associated with low-back pain are mechanical in nature. Epidemiological and biomechanical studies have suggested that there is a link between sudden and unexpected loading, such as slips and falls, and low- back injuries. Under these circumstances, motor control of the mechanical stability of the lumbar spine is crucial in determining trunk kinematic response to sudden loading and the subsequent likelihood of injury. Compared to healthy controls, however, LBP patients exhibit deficits in motor control such as delayed trunk muscle reflex response, poor trunk positioning sense, and impaired postural control. These deficits may constitute predisposing risk factors for sustaining an injury, a compensation/pain avoidance mechanism, or they may be the consequence of damage sustained by the lumbar spine tissues. The objective of the proposed research is to improve our understanding of the relationship between the measured motor control deficit and LBP. Two experimental studies and a post-hoc analysis of the entire data set form the 3 specific aims. The first prospective design study will consist of the initial testing and a 2- year follow-up of varsity athletes. The goal is to determine whether poor motor control of the lumbar spine increases the risk for sustaining a low-back injury. The second randomized prospective study will be conducted to document the changes in motor control of the lumbar spine in LBP patients before and after standard and modified rehabilitation programs that emphasize motor control training. Several tests, developed in preliminary studies, will quantify the deficit in the motor control in LBP individuals: response of trunk muscles to a sudden, multi-directional load release and the stability of the lumbar spine, and postural control of the trunk in unstable sitting. Correlations between the above measures of motor control and other variables in the LBP population will be determined in the third specific aim. These additional variables will include: trunk position and motion proprioception, objective and subjective measures of physical function, diagnosis and duration of symptoms, and personal characteristics such as age and gender. The results of the proposed research will have a significant clinical relevance for designing more effective prevention, diagnosis, and rehabilitation strategies for LBP. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: MOTOR MAP PLASTICITY IN CONSTRAINT THERAPY FOR STROKE Principal Investigator & Institution: Good, David C.; Professor; Neurology; Wake Forest University Health Sciences Winston-Salem, Nc 27157

30 Physical Therapy Timing: Fiscal Year 2002; Project Start 02-MAY-2002; Project End 31-MAR-2006 Summary: This study will evaluate the effect of a well-defined physical intervention (constraint-induced movement therapy (CIMT)) on cortical motor reorganization following stroke using transcranial magnetic stimulation (TMS) and functional magnetic resonance imaging (fMRI). The primary objectives are 1) to determine whether TMS motor maps or fMRI activation predictably change following CIMT, 2) to assess whether this change correlates with motor recovery, and 3) to identify possible mechanisms underlying that change. Eighty patients participating in a randomized multicenter trial (EXCITE) of CIMT administered either immediately or one year later will be studied. Clinical assessment, TMS and fMRI will be obtained prior to randomization into the treatment arms, and repeated within three days of completing CIMT (or at the equivalent time for patients randomized to delayed treatment), and one year later. The primary focus of the study will be changes in the primary motor cortices (FMC's) of each hemisphere in response to CIMT, but we will also qualitatively evaluate activation changes in other motor regions. Outcome measures for TMS will include indices of cortical map area and center of gravity to evaluate changes in size and directional shift of motor maps over time. Functional MRI outcome measures will be generated from a volume of interest (VOI) analysis of activation in the PMC during a motor task, and will parallel TMS measures. In addition, a \"laterality index\" will measure the relative activation in the PMC's contralateral and ipsilateral to hand movement. Clinical outcome measures will be obtained as part of the EXCITE trial, and will include the laboratory-based Wolf Motor Function Test and a measure of real life use of the stroke- affected arm: the Motor Activity Log. Nonparametric statistical analyses will be used to examine the relationship between changes in TMS maps, fMRI activation and clinical outcome for each group of patients. The study is a unique opportunity to use non- invasive methods to study cortical plasticity in subjects receiving a specific therapy intervention, compared to a control group. We expect to identify specific patterns of change in TMS motor maps and fMRI activation patterns in response to the CIMT intervention. The project will validate the concept that physiological cortical motor changes after stroke are closely correlated with motor improvement and are influenced by a physical intervention. This could lead to the development of new rehabilitative strategies based on the interaction between therapeutic interventions and the physiology and anatomy of recovery. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: NEUROBIOLOGY OF MUSCULOSKELETAL PAIN Principal Investigator & Institution: Sluka, Kathleen A.; Physical Therapy and Rehabilitation Science; University of Iowa Iowa City, Ia 52242 Timing: Fiscal Year 2001; Project Start 01-JUL-2001; Project End 30-JUN-2006 Summary: (Taken from the applicant's abstract): The long-term goals are to gain a better understanding of pain associated with the musculoskeletal system and the analgesia produced by physical therapy treatments. The award will allow more research-related time to expand current and develop new collaborative efforts. These collaborative efforts will be aimed at developing new techniques (isolated primary afferent recording and push-pull perfusion), new ideas (mechanisms of analgesia produced by joint mobilization) and expanding current ideas (TENS, microdialysis, muscle hyperalgesia). Interactions with scientists from multiple basic science (Anatomy, Neurosciences, Pharmacology, Chemistry, Molecular Biology) and clinical disciplines (Physical Therapy, Internal Medicine, Anesthesia, Pathology, Chiropractic) provide an interdisciplinary perspective to the examination of musculoskeletal pain and physical

Studies 31 therapy pain treatments. Group journal clubs and laboratory meetings are held weekly with several laboratories (Gebhart, Brennan, Hammond, Proudfit, Sluka) investigating pain. The research proposal in this application is designed to characterize a newly developed animal model of chronic pain induced by two unilateral injections of low pH saline into the gastrocnemius muscle. In the work proposed they hypothesize that the development of the long lasting bilateral hyperalgesia is dependent initially on activation of acid sensing ion channels (ASIC) from the site of injection. Activation of acid sensing ion channels results in long lasting, widespread hyperalgesia that is sustained by activation of central mechanisms in the spinal cord. These proposed studies are intended to help in the understanding and thus potential treatment of chronic muscle pain including such conditions as fibromyalgia, myofascial pain and low back pain. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: NMES FOR OLDER INDIVIDUALS AFTER TOTAL KNEE ARTHROPLASTY Principal Investigator & Institution: Snyder-Mackler, Lynn; Professor; Physical Therapy; University of Delaware Newark, De 19716 Timing: Fiscal Year 2002; Project Start 15-MAR-2002; Project End 28-FEB-2007 Summary: Reduced muscle strength from illness or injuries often leads to loss of function and independence in the elderly. The recovery of muscle strength and function in disabled elderly individuals is a major challenge in rehabilitation. The etiology of the muscle weakness with injury or age is fully elucidated. Training programs designed to maximize strength gains in young individuals may not be optimal in the elderly because the cause of the weakness and the morphology of the muscle may be different for young vs. old people. The overall goal of this work is to determine if physiologically and morphologically based rehabilitation programs are more effective than traditional rehabilitation to counter changes in muscle strength and function in older individuals. Neuromuscular electrical stimulation (NMES) may be used to improve strength and function following injury or surgery. This study provides motivation for exploring the use of NMES with the elderly. We posit that using NMES to augment a traditional rehabilitation program for elderly patients with osteoarthritis following total knee arthroplasties (TKA) will result in greater strength and functional gains than using only traditional rehabilitation. Elderly patients with osteoarthritis who undergo TKAs serve as ideal subjects for testing the effectiveness of rehabilitation programs become those patients almost always exhibit marked quadriceps weakness that is resistant to traditional physical rehabilitation. More than 300,000 TKAs are performed each year in the United States to treat osteoarthritis of the knee in older individuals. Neuromuscular electrical stimulation (NMES) may be used to improve strength and function following injury or surgery. This study provides motivation for exploring the use of NMES with the elderly, We posit that using NMES to augment a traditional rehabilitation program for elderly patients with osteoarthritis following total knee arthroplasties (TKA) will result in greater strength and functional gains than using only traditional rehabilitation. Elderly patients with osteoarthritis who undergo TKAs serve as ideal subjects for testing the effectiveness of rehabilitation programs become those patients almost always exhibit marked quadriceps weakness that is resistant to traditional physical rehabilitation. More than 300,000 TKAs are performed each year in the United States to treat osteoarthritis of the knee in older individuals. So, the successful rehabilitation of elder patients following TKA is an important and challenging problem. The specific aims of this proposal are: 1) To assess the effectiveness of high-level neuromuscular electrical stimulation is an

32 Physical Therapy adjunct to ongoing intensive, early rehabilitation in restoring quadriceps strength and improving the functional outcome after primary TKA, and 2) To identify the physiological and morphological bases for improvements in quadriceps strength and functional outcome. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: OPTIMIZING MUSCLE FUNCTION IN CEREBRAL PALSY Principal Investigator & Institution: Damiano, Diane L.; Associate Professor; Barnes- Jewish Hospital Ms 90-94-212 St. Louis, Mo 63110 Timing: Fiscal Year 2001; Project Start 01-SEP-1997; Project End 31-AUG-2003 Summary: Cerebral palsy (CP) is the most prevalent physical disability occurring in childhood, for which no cure is available. All current treatments such a surgery and physical therapy aim solely to alleviate the peripheral effects of this central nervous system disorder, often with limited and inconsistent success. A prevalent clinical system that has long been recognized, but rarely addressed therapeutically in this population is muscle weakness. While strength training is routinely used in the adult orthopaedic population and in athletes to increase force production or alter muscle imbalance, this type of intervention is grossly under- utilized in pediatric rehabilitation, and in particular children with CP. No evidence exists to support the clinical prejudice against strength training and testing in cerebral palsy. In fact, research findings are accumulating toe the contrary, demonstrating that individuals with CP are indeed weak, the degree of weakness has a direct relationship to motor performance, and strengthening programs can produce positive functional outcomes. However, the neurophysiological and biomechanical bases of weakness in CP remain poorly understood. An additional concern is that the two major surgical interventions in ambulatory children with spastic diplegia, muscle-tendon lengthening (orthopaedic surgery) and selective dorsal rhizotomy (neurosurgery), often serve to exacerbate or unmask the symptom of weakness, which can be problematic in children who are already weak. The ultimate goal of this project is to improve motor outcomes in CP by first exploring the mechanisms that lead to diminished force production and defining the relative role of weakness in the functional motor deficit in spastic CP. This will be accomplished by isokinetic and electromyographic evaluation to examine voluntary and involuntary muscle responses in children with CP at the knee and ankle joint throughout the range of motion and at different movement speeds. Muscle performance will then be related to validated pediatric measures of functional status and disability. Lastly, the interaction of strength with surgical interventions will be determined by quantifying the effects of orthopaedic and neurosurgery on strength and functional measures, and assessing whether the addition of a strengthening program enhances surgical outcomes. Strength is an essential component of normal motor control that is deficient in CP, but can be altered through training. Continued research, as proposed here, needs to be conducted to verify and solidify the role of strengthening in the rehabilitation of children with CP. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PAIN MANAGEMENT AND FUNCTIONAL RECOVERY IN OLDER ADULTS Principal Investigator & Institution: Morrison, R Sean.; Geriatrics & Adult Development; Mount Sinai School of Medicine of Nyu of New York University New York, Ny 10029 Timing: Fiscal Year 2003; Project Start 01-JUL-2003; Project End 30-JUN-2007

Studies 33 Summary: (provided by applicant): Uncontrolled pain is a major impediment to post- operative functional recovery. Despite major advances in the understanding and treatment of pain, under treatment of pain, particularly post-operative pain remains a persistent problem in the United States. Although data exist regarding the adverse outcome of untreated pain in younger adults as well as the beneficial effects of treating it, relatively little is known about the impact of post-operative pain on older adults - the most rapidly growing segment of the population. Older adults who undergo lower extremity orthopedic surgery (e.g., hip arthroplasty, knee arthroplasty, open reduction and internal fixation (ORIF)) experience intense post-operative pain and are at high risk for sub-optimal analgesic therapy. Higher pain levels following elective hip/knee arthroplasty and ORIF have been associated with increased lengths of stay in both acute care and rehabilitation hospitals, increased complications, delays in ambulation, aberrant gait patterns, impaired functional recovery at 6 months, and increased suffering. Given the paucity of data with respect to the effective treatment of pain in the geriatric patient, the rapid growth of the elderly population, and the increasing number of geriatric patients undergoing surgery - particularly orthopedic procedures- we propose to examine the effect of a multi-component and inter-disciplinary intervention designed to improve the detection and management of pain on functional and clinical outcomes in older adults admitted to an acute rehabilitation hospital following lower extremity orthopedic surgery. The intervention includes rigorous assessment of pain both at rest and with physical therapy, scheduled titration of analgesic medications to ensure patients are comfortable at rest and that pain does not interfere with transfers and ambulation, and pre-emptive analgesia prior to physical therapy to maximize the duration and intensity of rehabilitation. The analgesic protocol will be placed on one of 3 acute rehabilitation units at Mount Sinai Hospital. Patients from the intervention unit and 2 control units will be enrolled by means of a prospective matching strategy. The project will examine the impact of this generalizable intervention on pain levels, lower extremity performance, functional status, health related quality of life, and utilization. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PHYSICAL AND OCCUPATIONAL THERAPY FOR OLDER PERSONS Principal Investigator & Institution: Freburger, Janet K.; None; University of North Carolina Chapel Hill Office of Sponsored Research Chapel Hill, Nc 27599 Timing: Fiscal Year 2001; Project Start 30-SEP-2001; Project End 29-SEP-2004 Summary: (provided by applicant): Community based older persons, especially those with functional limitations and disability, use a variety of health care providers to maintain and/or improve their health and functional capabilities. Physical and occupational therapists represent one group of health care providers that primarily focus on improving, maintaining, or limiting decline in the functional capabilities of the older person. The broad objective of the proposed study is to advance our understanding of the access to and effectiveness of physical and occupational therapy for community based older persons. This study will be population based, analyzing several years of data from the Medicare Current Beneficiary Survey. The first aim of the study is to identify determinants of therapy use. Analyses will be conducted to identify predisposing, enabling, and need characteristics associated with the use of physical and occupational therapy. Determinants of therapy use in the home or outpatient setting will also be identified. And finally, the relationship between predisposing, enabling, and need characteristics and intensity of therapy use will be examined. The second aim of the study is to examine the relationship between therapy use and changes in functional

34 Physical Therapy status. Users of physical and occupational therapy will be identified and analyses will be conducted to examine the relationship between intensity of therapy use and changes in functional status, while controlling for patient characteristics and illness severity. The feasibility of examining changes in functional status among users and nonusers of physical and occupational therapy will also be explored using instrumental variable estimation or a case-control approach. Little is known about whether community based older persons have appropriate access to therapy services. Data on the effectiveness of physical and occupational therapy for community based older persons is also limited. Because recent changes in Medicare reimbursement have had a direct impact on the provision of therapy services, examining issues surrounding the use and effectiveness of these services is timely and may inform future Medicare policy. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PHYSICAL CAM THERAPIES FOR CHRONIC LOW BACK PAIN Principal Investigator & Institution: Eisenberg, David M.; Instructor in Medicine; Beth Israel Deaconess Medical Center St 1005 Boston, Ma 02215 Timing: Fiscal Year 2001; Project Start 01-SEP-2000; Project End 28-FEB-2002 Summary: Back problems are among the most prevalent conditions afflicting adults in general and the second most common condition reported by persons over age 65. Furthermore, back pin in general is the leading reason for the use of complimentary or alternative medicine (CAM) therapies by adults of all ages. Despite the common use of CAM therapies for back pain, little is known about how they compare with each other or with conventional medical therapies in terms of effectiveness and cost. Studies evaluating back pin treatments for older adults (greater than or equal to 65 years old) are particularly rare. This study will lay the groundwork for a full-scale trial that evaluates the relative effectiveness and costs of the three most commonly used physical CAM therapies (acupuncture, chiropractic, and massage) for both older and younger adults with chronic low back pain. During Phase I, we will develop, test and refine specific components of a randomized clinical trial evaluating acupuncture, chiropractic and massage for chronic low back pain. This will include specification of treatment and comparison groups, subject selection criteria, recruitment and retention strategies, and development of Phase I to conduct a pilot study designed to evaluate the three physical CAM treatments. Thirty persons with chronic low back pain will be randomized to each of the following groups: acupuncture, chiropractic, massage, and continued usual care. The subjects randomized to each intervention will be equally divided between persons over and under age 65. (Recruitment will include subjects in their 70s, 80s, and older.) The pilot study will permit us to identify and resolve unanticipated problems and to estimate the sample sizes required for an adequately powered full-scale trial. At the conclusion of this project, we will be prepared to write a competitive grant proposal to evaluate the most commonly used CAM therapies for treating both older and younger adults with chronic low back pain. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PHYSICAL THERAPY, AN ANTIFLAMMATORY SIGNAL ON ARTHRITIS Principal Investigator & Institution: Agarwal, Sudha; Associate Professor; Dental Medicine; University of Pittsburgh at Pittsburgh 350 Thackeray Hall Pittsburgh, Pa 15260 Timing: Fiscal Year 2001; Project Start 19-SEP-2001; Project End 30-JUN-2004

Studies 35 Summary: (provided by applicant): Osteoarthritis and rheumatoid arthritis are diseases of complex etiopathology associated with progressive inflammation and cartilage destruction. Rehabilitative physical therapies such as continuous passive motion (CPM)/exercise yield beneficial effects on arthritic joints as well as on post-surgical arthritic joints by an as-yet-unknown mechanism, but one that is likely to involve mechanical activation of cells. Since inflammatory cytokines like IL-1B play a major role in cartilage destruction, it is the hypothesis that mechanical strain exerts anti- inflammatory effects on arthritic joints by blocking proinflammatory signals and subsequent gene induction induced by IL-1. This is based on the facts that, in vitro, chondrocytes respond to cyclic tensile strain (CTS) by suppression of IL-1-dependent proteins that are responsible for cartilage degradation. CTS simultaneously induces gene exression of proteins inhibited by IL- 1B, that are reparative in nature. These effects of CTS are mediated via inhibition of IL-1B-induced nuclear factor (NF)-kB translocation to the nucleus, as well as the synthesis of its subunit. CTS exerts these effects at concentrations of IL-1B similar to those present in inflamed synovial joints, suggesting the clinical relevance of actions of mechanical strain. In this proposal the PIs wish to confirm in vitro findings using an in vivo model system of antigen induced arthrits (AIA) and an apparatus that subjects arthritic joints to CPM. Long term goals are to understand the molecular mechanisms of stress-induced anti-inflammatory responses that limit the degeneration in joint diseases and constitute the basis for rehabilitative physical therapies like CPM. Specifically, the PIs will (i) determine if CPM therapy exerts its beneficial effects on the arthritic joints by regulating the synthesis of catabolic proteins or their inhibitors. (ii) determine if CPM therapy exerts its beneficial effects on arthritic joints via induction of matrix-associated proteins. (iii) determine if the intracellular mechanisms of CPM in vivo are mediated via inhibition of nuclear factor (NF)-kB subunits p65 and p50 synthesis in the tissues of knee joints from CPM treated and untreated rabbits with AIA. This understanding of the signalling pathways that mediate the beneficial effects of mechanical strain is necessary for defining the biological basis for the efficacy of CPM/exercise, for the development of defined parameters for safe application of physical therapies to accelerate cartilage repair as well as for the use of CPM in novel non-invasive rehabilitative therapies for not only cartilage repatr but also for other diseases. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PHYSICAL, COGNITIVE AND MENTAL HEALTH IN SOCIAL CONTEXT Principal Investigator & Institution: Marsiske, Michael; Associate Professor; Ctr for Gerontological Studies; University of Florida Gainesville, Fl 32611 Timing: Fiscal Year 2003; Project Start 01-MAY-2003; Project End 30-APR-2008 Summary: (provided by applicant): The Institute on Aging (IoA) at the University of Florida (UF) seeks funding to support its predoctoral research-training program in aging of physical, cognitive and mental health in social contexts. With the co-location and cooperation between UF's health sciences and liberal arts campuses, as evinced by the strong levels of collaboration documented in this proposal, located close to urban and rural environments, UF is uniquely positioned to offer training in the psychosocial elements of health and disease (e.g., sensorimotor antecedents of cognitive decline in aging), in a socially diverse State. The training program is led by a Training Director with over seven years of experience with a particular model that includes multidisciplinary research training coupled with strong disciplinary education. UF has recently reinvigorated its investment in aging research, although its institutional

36 Physical Therapy commitment to aging (as evidenced by the establishment of its first Center on aging) is over 50 years old. In the past two years alone, 14 new aging faculty (to date) have been hired at UF. At present, over 40 faculty have identified themselves as \"Core Training Faculty\" in the IoA, representing the disciplines of psychology, sociology, nursing, physical therapy, occupational therapy, medicine, geography, audiology, linguistics, interior design, and others. This group is committed to mentoring students in a program that includes simultaneous admission to a disciplinary department (for the Ph.D.) and to the IoA Predoctoral Research Training program. The core components of the IoA training program include: (1) assignment of each student of multi-disciplinary mentoring team, literally on their first day of arrival, including a primary mentor form the performance model, in which students begin each academic year with their mentoring team to set career plan-relevant quantifiable goals in the domains of research, education, and service. Mentoring team meetings throughout the year to assess and support goal progress; (3) a weekly campus-wide colloquium series featuring atop national speakers, local researchers in aging, and professional development sessions; and (4) required supplemental coursework in Aging and Statistics/Methodology. In addition, our mentoring team approach allows us to actively engage energetic newer faculty in primary mentoting roles, while supplementing and complementing them with seasoned, productive senior investigators. Our students are therefore poised not only for research in traditional departments, but also in clinical research facilities, and multidisciplinary gerontology environments. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PHYSIOLOGICAL ADAPTATIONS TO EXERCISE IN BURNED CHILDREN Principal Investigator & Institution: Suman, Oscar E.; Surgery; University of Texas Medical Br Galveston 301 University Blvd Galveston, Tx 77555 Timing: Fiscal Year 2002; Project Start 02-APR-2002; Project End 31-MAR-2007 Summary: (Applicant's abstract) Dr. Suman's long-term career goals and interests are to understand the mechanism(s) by which adaptations occur in the cardiovascular, pulmonary and skeletal muscle systems in response to exercise. Broadly, he foresees himself establishing a scientific investigative career in physiology and using exercise as an interventional tool against functional disability and disease. His immediate career goals involve investigating the adaptations to exercise that occur in severely burned children. Currently, Dr. Suman proposes to continue his research at the University of Texas Medical Branch and Shriners Hospitals for Children, in collaboration with Dr. David N. Herndon, Dr. Robert R. Wolfe and Dr. Daniel L. Traber. Research: The physiological response to a severe burn injury includes a persistent and extensive skeletal muscle catabolism and weakness that leads to a low physical capacity. In non- burn individuals, exercise training induces adaptations that include improvement of cardiovascular (CV) and muscle function. However, whether exercise confers these adaptions in burned children in currently unknown. A better understanding of the adaptations to exercise training is important and relevant in burns, where alterations in cardiovascular and muscle function are major obstacles in the return to physical activities of daily living. The proposed study will test the hypothesis that exercise, in severely burned children, will improve CV and muscle performance by increasing cardiac function, oxygen uptake and utilization, and skeletal muscle mass. Specific Aim 1 will assess whether decreases in CV and skeletal muscle function in severely burned children are due to compromised cardiac performance and skeletal muscle oxidative function and decreased concentration of myosin heavy chain. Specific Aim 2 will assess

Studies 37 whether the compromised level of CV and muscle function will be improved with exercise training. Specific Aim 3 will assess whether administration of an anabolic agent (oxandrolone) to burned children will further enhance the effects of exercise on CV and skeletal muscle functional capacity. We expect these Specific Aims to serve as a springboard for future studies in the treatment and long-term rehabilitation of burned children. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PILOT--CONSTRAINT INDUCED MOVEMENT THERAPY IN SA STROKE Principal Investigator & Institution: Levin, Harvey S.; Professor/Director of Research; University of Washington Seattle, Wa 98195 Timing: Fiscal Year 2001 Summary: This 2-year project evaluates the feasibility and efficacy of constrain induced (CI) movement therapy to enhance recovery of motor function in the affected upper limp of patients with ischemic stroke. Motor weakness of the limbs contralateral to the cerebral hemisphere involved in unilateral stroke is a frequent deficit which is a major cause of disability. Animal models and clinical observations have indicated that individuals learn to disuse their paretic limbs and rely more on their intact limbs. Studies in animals and previous clinical trials have shown that constraining the intact limb while training the affected limb improves motor function. However, the feasibility and efficacy of initiating CI Movement therapy during the subacute phase of recovery from ischemic stroke have not been reported. This project is a randomized parallel group design to evaluate the feasibility and efficacy in instituting 2 weeks of daily CI movement therapy combined with training of the impaired upper limb beginning on the eighth day after ischemic stroke. Twenty-eight right handed patients admitted to the Memorial-Herman Hospital Stroke unit who satisfy the selection and exclusion criteria and control condition with the distal motor score of the NIH Stroke Scale and age as stratification variables. Daily training of the impaired limb will also be carried out in both treatment arms during the 2 week period. Two physical therapists will administer all treatment with 1 therapist treating half of the patients in each condition. Outcome measures of upper limb motor function, which include Actual Amount of Use, Motor Activity Log, Grooved Pegboard, Wolf Motor Function Tests, and the motor subscale of the Functional Independence Measure, will be performed by a third physical therapist who is blinded to the patients' treatment condition. In view of animal model studies indicating that lesion volume can enlarge when the intact limb is restrained during the first week after injury, this project includes magnetic resonance imaging (MRI) to measure change in lesion volume from pre-treatment to 3 months post-injury. Reorganization of cortical motor function is studied by functional MRI at 3 months after stroke. The Functional Neuroimaging Core at UCLA will assist with designing the acquisition and analysis of fMRI data. Data management and analysis will be performed in the Cognitive Neuroscience Laboratory with assistance from the Experimental Design and Statistics Core of the University of Washington. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PRESERVING MOBILITY OF JRA CHILDREN USING NOCTURNAL TES Principal Investigator & Institution: Mcguire, John R.; Phys Med and Rehabilitation; Medical College of Wisconsin Po Box26509 Milwaukee, Wi 532264801

38 Physical Therapy Timing: Fiscal Year 2001; Project Start 20-SEP-1997; Project End 31-AUG-2003 Summary: Therapeutic electrical stimulation (TES) is a modified form of traditional electrical stimulation which involves the use of low-intensity, sub- threshold electrical stimulation applied during sleep. TES is well tolerated and has been used since 1988 in Canada for children with a variety of neuromuscular conditions. The efficacy of TES has not yet been examined in the child with juvenile rheumatoid arthritis (JRA). The purpose of this R29 proposal is to develop and test this innovative use of low-level muscle electrical stimulation as an adjunctive therapy to minimize or prevent movement limitations in the child with juvenile rheumatoid arthritis. Twenty JRA children with bilateral knee joint involvement will be studied during six months while using nocturnal TES as an adjunct to a physical therapy home program. This low-level subthreshold stimulation is done while the child is sleeping six nights a week. This study is very realistic for the child with juvenile rheumatoid arthritis as it done during sleep, the technology is noninvasive, easy to learn and does not add to \"the burden of care.\" The electrical stimulation will be done unilaterally to allow the other leg to serve as a control. The child will be monitored in three major ways: clinical exam, quantitative muscle strength and muscle bulk, and functional assessments. The monthly clinical exam will document bilateral lower extremity A/PROM, MMT of key functional lower extremity muscle groups, leg length, thigh circumference and the Kraus-Weber flexibility test score. The quantitative muscle strength will be assessed by monthly isometric knee extensor torque measurements. The functional assessment will include monthly Childhood Health Assessment Questionnaire (CHAQ), and a modified Pediatric Evaluation of Disability Inventory (PEDI). At the beginning and end of the 6 month period, a gait analysis study including physiologic cost index as well as ultrasound measurement of quadriceps muscle thickness will be done. Our hypothesis is that nocturnal therapeutic electrical stimulation will minimize quadriceps weakness and/or atrophy thereby reducing the potential impairments of muscle weakness, knee flexion contracture and gait deviations which may contribute to long-term disability in the JRA population. If the efficacy of this intervention in preserving mobility is demonstrated, future research would explore the underlying neuromuscular and neuroendocrine mechanisms responsible for the clinical effect. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PREVENTION OF FUNCTIONAL DISABILITY IN AT RISK ELDERS Principal Investigator & Institution: Gill, Thomas M.; Associate Professor; Internal Medicine; Yale University 47 College Street, Suite 203 New Haven, Ct 065208047 Timing: Fiscal Year 2001; Project Start 01-JAN-1998; Project End 31-DEC-2002 Summary: (Adapted from applicant's abstract). According to the applicant intervention strategies to date have focused largely on the restoration of function among disabled elderly persons in the context of rehabilitation after an acute medical event, such as a stroke or hip fracture. There have been few attempts to develop strategies aimed at \"prehabilitation\" (PREHAB), which is the prevention of functional dependence and decline among persons who have not sustained an acute illness or injury. The overall objective of this project is to test the efficacy of a home-based PREHAB strategy to prevent functional decline in a high-risk group of physically impaired, community- living elderly persons who do not have severe memory loss or impaired orientation. Community-living persons, over 75 years will be screened for eligibility during non- urgent clinic visits at two large primary care sites. After comprehensive home assessment, 160 physically impaired elders will be randomized, using a blocked design that is stratified by clinic site, severity of physical impairment, and age to receive either

Studies 39 the control group strategy (EDUCATE), a 6-month education program covering several content areas in general health practices and health promotion, or a home-based intervention strategy (PREHAB) -- which is a 6-month training program of physical therapy, to include muscle strengthening, joint range of motion, foot care, and balance, gait, transfer, and stair training, plus functional therapy to include training and instruction in safe and effective performance of the task needed to complete ADLs and selected IADLs, provision of appropriate adaptive equipment, and environmental modifications. Functional assessments will be completed in all participants at baseline and at six and twelve months by trained staff who will be kept unaware of group assignments. The specific aims of the project are 1) to determine whether the home- based PREHAB strategy is superior to the EDUCATE strategy in preventing decline in ADL-IADL function, and in decreasing the use of formal and informal care, including home care and nursing home care; 2) if the PREHAB strategy proves successful to identify the predictors of response to the intervention and to determine whether its benefit is mediated, as hypothesized, by improvements in both physical capability and functional self-efficacy. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: PT/PHD PREDOCTORAL TRAINING PROGRAM Principal Investigator & Institution: Binder-Macleod, Stuart A.; Professor & Chair; Physical Therapy; University of Delaware Newark, De 19716 Timing: Fiscal Year 2003; Project Start 20-AUG-1996; Project End 30-APR-2008 Summary: (provided by applicant): Recent advances in behavioral, biological, and engineering sciences provide exciting opportunities to attack important problems faced by people with disabilities. Scientists with strong backgrounds in rehabilitation, who bring multidisciplinary research approaches to answer important questions related to rehabilitation, are scarce. The goal of this pre-doctoral training program is to improve the quality and quantity of individuals who will contribute to the knowledge base and practice of physical rehabilitation. This training program, coordinated through the Department of Physical Therapy, includes faculty members from the Mechanical Engineering and Physical Therapy Departments at the University of Delaware. The program fuses two independent training programs: an entry level Doctorate in Physical Therapy (DPT), designed to train clinical physical therapists, and the PhD in Biomechanics and Movement Sciences (BMSC). Research concentrations during the PhD portion of the program include: Applied Physiology, Exercise Physiology, Biomechanics, Motor Control, and Rehabilitation Technology. The program is analogous to the MD/PhD programs that are designed to train medical scientists. Students in the proposed program become both physical therapists and research scientists. Trainees are selected from a pool of outstanding students with diverse undergraduate backgrounds who enter the DPT program. Many of these students express an interest in research before admission to the program. Unfortunately, because of the sizable debt incurred during graduate school and the opportunity to earn the salaries that clinical physical therapists enjoy, very few of these students go on to pursue the PhD. This training program attracts individuals who have a sincere interest in physical rehabilitation research and tracks them early in their training into research careers. The need for these individuals is enormous. Both new and established programs need doctorally trained individuals for teaching and research positions. Graduates of this training program are ideal faculty members who will foster excellence in rehabilitation research. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

40 Physical Therapy • Project Title: QUANTATIVE MEASUREMENT OF LOW BACK IMPAIRMENT Principal Investigator & Institution: Kotzar, Geoffrey M.; Research Scientist; Biomec, Inc. 1771 E 30Th St Cleveland, Oh 44114 Timing: Fiscal Year 2002; Project Start 19-SEP-2002; Project End 31-AUG-2003 Summary: (provided by applicant): Injuries to the lower back are the second most prevalent disorder presented to medical practitioners today (second only to upper respiratory ailments) and are often the most difficult to diagnose or treat. The myriad of current methods used in evaluating lower back injuries and disorders (LBDs) are very subjective. Consequentially, the number of insurance claims and the amount of each claim push this ailments costs over the $100 billion mark in the US alone. There are no clinical methods/devices that remove the subjectivity from the assessment of impairment due to LBDs for most patients. A quantitative laboratory research tool (device) has been developed and shown to add objectivity to the evaluation of LBDs. One objective of this project is to update the technology, making a device suitable for clinical use. Another objective is to assess the new tool against the current one in the laboratory to assure that no feature of the original device has been lost or compromised. Based on this assessment, a clinically viable device will be available for the quantitative evaluation of LBDs, which promises to reduce the subjectivity of the clinical evaluation and the subsequent costs in treating the disorder. PROPOSED COMMERCIAL APPLICATION: According to the U.S. Center for Healthcare Statistics, 80% of adults seek care for low back pain at some time in their lives, and 50% of adults have an episode of low back pain in any given year. The problem is wide spread, difficult to diagnose and expensive to treat. The potential markets for the device we propose to develop are physical therapy clinics, insurance companies, government organizations (NIOSH, OSHA, etc.), manufacturing companies (workplace assessment), orthopedic clinics, and companies that make office equiment (ergonomic assessment). Focussing only on the physical therapy clinics, there are over 98,000 such clinics according to data from the American Physical Therapy Association and the American Hospital Association. This number has remained relatively stable and could be expected to remain static over a forecast period of the next five years. Even with a small market penetration of only 0.1% per year, our sales can be expected to reach $2 million the first year and increase by $2 million per year over the next five years, for a total of 0.5% penetration and $10 million annually at the end of five years. At this rate, market saturation will not occur in any forseeable future. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: REHABILITATION ADHERENCE AND ACL RECONSTRUCTION OUTCOME Principal Investigator & Institution: Brewer, Britton W.; Psychology; Springfield College 263 Alden St Springfield, Ma 01109 Timing: Fiscal Year 2001; Project Start 11-SEP-1998; Project End 31-AUG-2003 Summary: An acute tear of the anterior cruciate ligament (ACL) is one of the more prevalent and debilitating of the 3-17 million sport- and recreation-related injuries that occur each year in the United States. Physical therapy protocols following surgical reconstruction of the ACL have become increasingly aggressive in recent years. There is scant evidence, however, that adherence to these \"accelerated\" rehabilitation regimens is related to postsurgical outcome. Accordingly, the primary purpose of the proposed study is to examine the relationship between adherence to an accelerated physical therapy protocol and rehabilitation outcome following ACL reconstruction. Secondary

Studies 41 purposes of the proposed study are to identify potential demographic and injury-related moderators of the adherence-outcome relationship and to evaluate the correspondence between patient self-report and objective assessment of adherence to a home exercise regimen after surgical reconstruction of the ACL. To accomplish the aims of the study, measures of adherence and outcome will be taken following ACL reconstruction. Self- reports of home exercise completion, objective assessment of home exercise completion, attendance at physical therapy appointments, and practitioner ratings of adherence during physical therapy appointments will be measured for six weeks postsurgery. Rehabilitation outcomes, including range of motion, laxity, functional ability, and subjective symptoms, will be measured preoperatively and at six months, one year, and two years postsurgery. Findings from the proposed study will have implications for rehabilitation practices following ACL reconstruction. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: REHABILITATION FOR SELF-MANAGEMENT OF PARKINSONS DISEASE Principal Investigator & Institution: Wagenaar, Robert C.; Professor; Phsyical Therapy; Boston University Charles River Campus 881 Commonwealth Avenue Boston, Ma 02215 Timing: Fiscal Year 2003; Project Start 01-JUN-2003; Project End 31-MAY-2006 Summary: (provided by applicant): The overall goal of the proposed research is to determine whether rehabilitation that focuses on self-management of health helps to improve the day-to-day functioning and quality of life of community-living clients with Parkinson's disease (PD), beyond the effects of medical treatment alone. Typically for people with PD, medical treatment declines in effectiveness over a variable number of years, and these individuals face a relentless progression into disability and lowered quality of life that can end in a need for custodial care. If a rehabilitation program can ameliorate disability and support a high quality of life by positively influencing mobility, communication, and healthful daily living skills, it is possible that more intensive use of medication could be postponed. As a result, people with this disease might benefit longer from medication and be less quickly referred to costly inpatient rehabilitation and long term care facilities. The proposed research uses rigorous methodology, which is rare for studies of rehabilitation with this population, and builds on our previous research toward understanding the role of rehabilitation in promoting health in people with PD. In a randomized controlled design, people with PD will be assigned to one of three conditions for a duration of 6 weeks: (i) medication only, (ii)medication plus 2 outpatient group rehabilitation sessions and 1 social activity session per week, or (iii)medication plus 2 outpatient group rehabilitation sessions and 1 home/community rehabilitation session per week. Rehabilitation will occur through integrated physical, occupational, and speech therapy services specialized to the self- management of health needs of people with PD. The first specific aim of the proposed study is to determine if increasing \"doses\" of self-management rehabilitation (from Conditions i to ii to iii) result in increasingly positive quality of life outcomes. The second aim is to document change in rehabilitation effects at 2 and 6 months post- intervention. The third aim is to describe possible active ingredients in the rehabilitation by measuring neuromuscular and voice function outcomes. The fourth aim is to provide evidence for the validity of self-management outcome measures for use with PD. It is hypothesized that there will be beneficial and lasting effects of rehabilitation for quality of life outcomes. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen

42 Physical Therapy • Project Title: REHABILITATION FOR STROKE AND HIP FRACTURE Principal Investigator & Institution: Munin, Michael C.; Physical Medicine and Rehabilitation; University of Pittsburgh at Pittsburgh 350 Thackeray Hall Pittsburgh, Pa 15260 Timing: Fiscal Year 2002; Project Start 26-SEP-2002; Project End 31-AUG-2004 Summary: (provided by applicant): Hip fracture is one of the leading healthcare problems requiring rehabilitation services in older Americans. Three models of rehabilitation treatment are available for patients recovering from hip fracture that include acute inpatient rehabilitation (AR), nursing home rehabilitation (NHR) and home care rehabilitation (HCR). These settings differ based on the timing, duration and intensity of services provided. No prior randomized study has been performed to determine the optimum rehabilitation treatment to improve the rate of functional recovery and return home to the community for patients with hip fracture. This planning grant will complete work in the following key domains during the two-year grant cycle to perform a randomized controlled trial (1) coordinating facilities to assist subject recruitment using state of the art bioinformatics systems within the University of Pittsburgh Medical Center Health System; (2) performing focus interviews to better understand patient, family, physician and therapist values concerning the randomization process; (3) determining the best method to risk stratify patients to different treatment settings that include random assignment to a home rehabilitation arm; (4) refining physical and occupational therapy algorithms using similar treatment goals at each location; (5) incorporating outcomes that are validated, objective and reliable measures of self-reported function and observed physical performance; and (6) standardizing data measurements in all rehabilitation environments through the implementation of quality control procedures. Co-investigators from the RAND Corporation will refine methods for data analysis using their extensive expertise in outcome assessment. At the end of this two-year planning grant, the investigators expect to be well positioned to perform a randomized controlled trial. Primary hypotheses will test whether AR subjects have higher function and a lower percentage of extended care facility placements than patients receiving NHR or HCR. Using novel methodology developed by the research team, secondary hypotheses will evaluate the relationship of functional outcomes and intensity of therapy to level of participation in therapy and physical activity measured by an activity monitor. Website: http://crisp.cit.nih.gov/crisp/Crisp_Query.Generate_Screen • Project Title: REHABILITATION INTENSIFICATION POST HIP FRACTURE Principal Investigator & Institution: Binder, Ellen F.; Medicine; Washington University Lindell and Skinker Blvd St. Louis, Mo 63130 Timing: Fiscal Year 2001; Project Start 01-AUG-1998; Project End 31-MAY-2003 Summary: (Adapted from the Applicant's Abstract): Hip fractures are a common problem among older adults, and can have a devastating impact on the ability of older patients to remain independent. A significant functional decline following a hip fracture has been documented, even among individuals who were functioning at high levels before the event. High risk patients include those with deficits in skeletal muscle strength during the post-fracture period. Standard ambulation is achieved with or without an assistive device. However, many patients have persistent strength and mobility deficits at the end of treatment which impair their capacity for independent function, and increase their risk of recurrent falls. The aim of this study is to evaluate the efficacy of a graduated physical therapy and weight-training program for community-