Original ArticlesProtocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit The Bringing Rehabilitation to American Veterans Everywhere ProjectMorris, David M. PhD, PT; Taub, Edward PhD; Mark, Victor W. MD; Liu, Wei PhD, MS; Brenner, Lisa PhD; Pickett, Treven PsyD, ABPP; Stearns-Yoder, Kelly BA; Bishop-McKay, Staci BS; Taylor, Andrea BA, BS, MPH; Reder, Laura LPTA; Adams, Terrie MS; Rimmer, James PhD; Dew, Dustin MA; Szaflarski, Jerzy MD, PhD; Womble, Brent MA; Stevens, Lillian PhD; Rothman, David MS; Uswatte, Gitendra PhDSection Editor(s): Caplan, Bruce PhD, ABPP; Bogner, Jennifer PhD, ABPP; Brenner, Lisa PhD, ABPP; Malec, James PhD, ABPP Author Information From the Departments of Psychology (Drs Taub, Mark, and Uswatte, Mss Bishop-McKay, Taylor, Reder, and Adams, and Mr Womble), Physical Therapy (Drs Morris and Uswatte), Physical Medicine and Rehabilitation (Dr Mark), Neurology (Drs Mark and Szaflarski), Occupational Therapy (Dr Rimmer), and UAB/Lakeshore Research Collaborative (Dr Rimmer and Mr Dew), University of Alabama at Birmingham; Edward Via College of Osteopathic Medicine, Auburn, Alabama (Dr Liu); National Intrepid Center of Excellence, Bethesda, Maryland (Dr Pickett); Departments of Psychiatry, Neurology, and Physical Medicine and Rehabilitation, University of Colorado and Denver Veteran's Medical Center, Denver (Dr Brenner); Rocky Mountain MIRECC, Denver, Colorado (Ms Stearns-Yoder); and Departments of Physical Medicine and Rehabilitation (Dr Stevens) and Psychology (Mr Rothman), Virginia Commonwealth University, Richmond. Corresponding Author: David M. Morris, PhD, PT, Department of Physical Therapy, 383 School of Health Professions Bldg, University of Alabama at Birmingham, Birmingham, AL 35294 (firstname.lastname@example.org). Concept/idea/project design provided by all the authors; participant recruitment by Uswatte, Taub, Mark, Bishop-McKay, Taylor, Brenner, Pickett, Stevens, Rothman, Stearns-Yoder, and Adams; data collection by Reder, Adams, Bishop-McKay, Taylor, Dew, Liu, Womble, and Szaflarski; intervention delivery by Bishop-McKay, Taylor, Adams, and Taub; data analysis by Uswatte and Taub; writing by Morris, Taub, and Uswatte; and project management by Uswatte, Taub, Bishop-McKay, Taylor, and Dew. This work was supported by the Assistant Secretary of Defense for Health Affairs through the Psychological Health and Traumatic Brain Injury Research Program under Award No. W81XWH-14-2-0167. ClinicalTrails.gov Identifier: NCT02339220. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense. Dr Szaflarski reports funding from the NIH, NSF, Shor Foundation for Epilepsy Research, Department of Defense, UCB Biosciences, NeuroPace Inc, SAGE Therapeutics Inc, Serina Therapeutics Inc, Greenwich Biosciences Inc, State of Alabama, and Eisai Inc. Dr Szaflarski reports serving as a consultant or on advisory boards of SAGE Therapeutics Inc, GW Pharmaceuticals Inc, NeuroPace, Inc, Upsher-Smith Laboratories, Inc, Medical Association of the State of Alabama, Serina Therapeutics Inc, LivaNova Inc, Lundbeck, and Elite Medical Experts LLC. He serves on editorial board for Epilepsy & Behavior, Journal of Epileptology (associate editor), Journal of Medical Science, Epilepsy Currents (contributing editor), and Folia Medica Copernicana. The authors declare no conflicts of interest. The Journal of Head Trauma Rehabilitation: July/August 2019 - Volume 34 - Issue 4 - p 268-279 doi: 10.1097/HTR.0000000000000460 Buy Metrics Abstract Constraint-induced movement therapy (CI therapy) has been shown to reduce disability for individuals with upper extremity (UE) hemiparesis following different neurologic injuries. This article describes the study design and methodological considerations of the Bringing Rehabilitation to American Veterans Everywhere (BRAVE) Project, a randomized controlled trial of CI therapy to improve the motor deficit of participants with chronic and subacute traumatic brain injury. Our CI therapy protocol comprises 4 major components: (1) intensive training of the more-affected UE for target of 3 hour/day for 10 consecutive weekdays, (2) a behavioral technique termed shaping during training, (3) a “transfer package,” 0.5 hour/day, of behavioral techniques to transfer therapeutic gains from the treatment setting to the life situation, and (4) prolonged restraint of use of the UE not being trained. The primary endpoint is posttreatment change on the Motor Activity Log, which assesses the use of the more-affected arm outside the laboratory in everyday life situations. Data from a number of secondary outcome measures are also being collected and can be categorized as physical, genomic, biologic, fitness, cognitive/behavioral, quality of life, and neuroimaging measures. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.