UH3NS133283

TELEREHABILITATION IN THE HOME AFTER STROKE: A RANDOMIZED, CONTROLLED, ASSESSOR-BLIND CLINICAL TRIAL (THE TR-2 TRIAL) - PROJECT SUMMARY HIGH DOSES OF INTENSIVE REHABILITATION THERAPY IMPROVE FUNCTIONAL OUTCOMES AFTER STROKE, BUT MOST PATIENTS DO NOT RECEIVE THIS, FOR REASONS THAT INCLUDE LIMITED ACCESS, DIFFICULTY TRAVELING, AND LOW MOTIVATION. TELEHEALTH CAN ADDRESS THESE OBSTACLES. A RECENT STROKENET TRIAL FOUND THAT A 6-WEEK COURSE OF INTENSIVE HOME-BASED DAILY ARM MOTOR TELEREHABILITATION SIGNIFICANTLY IMPROVED ARM FUNCTION AS WELL AS GLOBAL FUNCTION IN PATIENTS AVERAGING 4 MONTHS POST-STROKE, WITH EFFICACY COMPARABLE TO DOSE-MATCHED THERAPY DELIVERED IN-CLINIC. A DEFINITIVE TRIAL THAT COMPARES TELEREHABILITATION WITH USUAL AND CUSTOMARY CARE IS NOW NEEDED. THIS ISSUE WILL BE ADDRESSED IN THE “TELEREHABILITATION IN THE HOME AFTER STROKE: A RANDOMIZED, CONTROLLED, ASSESSOR-BLIND CLINICAL TRIAL (THE TR-2 TRIAL),” A CONTROLLED, ASSESSOR-BLIND, RANDOMIZED, PHASE III SUPERIORITY TRIAL THAT WILL RECRUIT 202 PATIENTS WITH SUBSTANTIAL ARM MOTOR DEFICITS 4 MONTHS AFTER STROKE ONSET AND RANDOMIZE THEM TO [1] A 6-WEEK COURSE OF INTENSIVE DAILY ARM MOTOR REHABILITATION THERAPY OR [2] USUAL CARE. AIM 1 OF THE TR-2 TRIAL HYPOTHESIZES THAT ADDING A 6-WEEK COURSE OF INTENSIVE ARM MOTOR TELEREHABILITATION TO USUAL CARE RESULTS IN SUPERIOR FUNCTIONAL OUTCOMES COMPARED TO USUAL CARE ALONE. THE PRIMARY OUTCOME MEASURES ARM FUNCTION (ACTION RESEARCH ARM TEST); THE SECONDARY OUTCOME MEASURES GLOBAL FUNCTION (MODIFIED RANKIN SCALE). AIM 2 WILL EXAMINE THE PREDICTIVE POWER OF AN IMAGING BIOMARKER. SELECTING THE RIGHT PATIENTS IS CHALLENGING IN STROKE CLINICAL PRACTICE AND TRIALS DUE TO THE ENORMOUS HETEROGENEITY OF THIS DISEASE. CLINICAL MEASURES INCOMPLETELY PREDICT THERAPY GAINS, BUT STUDIES FROM MANY LABS HAVE FOUND THAT THE EXTENT OF INJURY TO THE CORTICOSPINAL TRACT PREDICTS ARM MOTOR GAINS AFTER STROKE. THE BIOLOGICAL MODEL UNDERLYING INTENSIVE ARM MOTOR TELEREHABILITATION IS THAT THERAPY ACTIVATES MULTIPLE BRAIN MOTOR CIRCUITS, WITH THE CORTICOSPINAL TRACT BEING THE FINAL EFFERENT PATHWAY BY WHICH TREATMENT GAINS ARE EXPRESSED, AND SO AN INTACT CORTICOSPINAL TRACT IS NEEDED TO BENEFIT FROM THERAPY. THE SPECIFIC HYPOTHESIS IS THAT ANY BENEFIT OF TELEREHABILITATION OVER USUAL CARE IS A FUNCTION OF THE EXTENT TO WHICH THE CORTICOSPINAL TRACT IS PRESERVED. AIM 3 WILL EVALUATE THE HEALTH ECONOMIC IMPACTS OF THE TWO TREATMENT GROUPS, WITH A FOCUS ON PATIENT HEALTH-RELATED QUALITY OF LIFE, AS THE EFFECTS OF TELEREHABILITATION THERAPY MUST BE CONSIDERED IN THE BROADER CONTEXT OF HEALTHCARE UTILIZATION. STROKE REMAINS A MAJOR CAUSE OF DISABILITY, AND MOTOR DEFICITS ARE A MAJOR CONTRIBUTOR. REHABILITATION THERAPY AFTER STROKE IS GENERALLY PROVIDED AT A VERY LOW DOSE, CAN BE HARD TO ACCESS, AND IS OFTEN NOT VERY MOTIVATING. OUR TELEREHABILITATION PROGRAM OVERCOMES THESE BARRIERS, WAS EFFICACIOUS IN PHASE I AND PHASE II MULTISITE TRIALS, AND WILL NOW BE EXAMINED IN COMPARISON TO USUAL CARE. THE TR-2 TRIAL IS EXPECTED TO GENERATE DEFINITIVE EVIDENCE THAT REHAB THERAPY HELPS POST-STROKE AT A TIME WHEN MANY MEDICAL SYSTEMS STOP PROVIDING REHAB CARE AND SO STANDS TO CHANGE CLINICAL PRACTICE WORLDWIDE.

Los Angeles University Of California

(1) TO SUPPORT EXTRAMURAL RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) INCLUDING: BASIC RESEARCH THAT EXPLORES THE FUNDAMENTAL STRUCTURE AND FUNCTION OF THE BRAIN AND THE NERVOUS SYSTEM, RESEARCH TO UNDERSTAND THE CAUSES AND ORIGINS OF PATHOLOGICAL CONDITIONS OF THE NERVOUS SYSTEM WITH THE GOAL OF PREVENTING THESE DISORDERS, RESEARCH ON THE NATURAL COURSE OF NEUROLOGICAL DISORDERS, IMPROVED METHODS OF DISEASE PREVENTION, NEW METHODS OF DIAGNOSIS AND TREATMENT, DRUG DEVELOPMENT, DEVELOPMENT OF NEURAL DEVICES, CLINICAL TRIALS, AND RESEARCH TRAINING IN BASIC, TRANSLATIONAL AND CLINICAL NEUROSCIENCE. THE INSTITUTE IS THE LARGEST FUNDER OF BASIC NEUROSCIENCE IN THE US AND SUPPORTS RESEARCH ON TOPICS INCLUDING BUT NOT LIMITED TO: DEVELOPMENT OF THE NERVOUS SYSTEM, INCLUDING NEUROGENESIS AND PROGENITOR CELL BIOLOGY, SIGNAL TRANSDUCTION IN DEVELOPMENT AND PLASTICITY, AND PROGRAMMED CELL DEATH, SYNAPSE FORMATION, FUNCTION, AND PLASTICITY, LEARNING AND MEMORY, CHANNELS, TRANSPORTERS, AND PUMPS, CIRCUIT FORMATION AND MODULATION, BEHAVIORAL AND COGNITIVE NEUROSCIENCE, SENSORIMOTOR LEARNING, INTEGRATION AND EXECUTIVE FUNCTION, NEUROENDOCRINE SYSTEMS, SLEEP AND CIRCADIAN RHYTHMS, AND SENSORY AND MOTOR SYSTEMS. IN ADDITION, THE INSTITUTE SUPPORTS BASIC, TRANSLATIONAL AND CLINICAL STUDIES ON A NUMBER OF DISORDERS OF THE NERVOUS SYSTEM INCLUDING (BUT NOT LIMITED TO): STROKE, TRAUMATIC INJURY TO THE BRAIN, SPINAL CORD AND PERIPHERAL NERVOUS SYSTEM, NEURODEGENERATIVE DISORDERS, MOVEMENT DISORDERS, BRAIN TUMORS, CONVULSIVE DISORDERS, INFECTIOUS DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, IMMUNE DISORDERS OF THE BRAIN AND NERVOUS SYSTEM, INCLUDING MULTIPLE SCLEROSIS, DISORDERS RELATED TO SLEEP, AND PAIN. PROGRAMMATIC AREAS, WHICH ARE PRIMARILY SUPPORTED BY THE DIVISION OF NEUROSCIENCE, ARE ALSO SUPPORTED BY THE DIVISION OF EXTRAMURAL ACTIVITIES, THE DIVISION OF TRANSLATIONAL RESEARCH, THE DIVISION OF CLINICAL RESEARCH, THE OFFICE OF TRAINING AND WORKFORCE DEVELOPMENT, THE OFFICE OF PROGRAMS TO ENHANCE NEUROSCIENCE WORKFORCE DEVELOPMENT, AND THE OFFICE OF INTERNATIONAL ACTIVITIES. (2) TO EXPAND AND IMPROVE THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. TO UTILIZE THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM, TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Neurological Disorders and Stroke (NNDS) [HHS - NIH]

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Los Angeles, California 900671907 United States

Single Zip Code

NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional) (PAR-20-285)

Amendment Since initial award the total obligations have increased 1384% from $300,000 to $4,453,239.