The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment

NCT02339220 | Completed DMC

• 1 other identifier: PT130232
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the value of Constraint-Induced Movement therapy (CIMT) for improving motor function and general fitness in adults with subacute and chronic traumatic brain injury (TBI), particularly TBI acquired during active military duty, in comparison to a Lakeshore Enriched Fitness Training (LEFT). The study will also test the effect of a set of enhanced versus "standard" procedures for transferring therapeutic gains from treatment setting to everyday life. Lastly, this study will determine whether any therapeutic effects observed are correlated with neuroplastic white matter or grey matter changes.

Conditions

Traumatic Brain Injury

Keywords

Constraint-Induced Movement Therapy; Physical Therapy; Rehabilitation; Occupational Therapy; Fitness Training; Recovery of Function; Neuroplasticity; Exercise Therapy; Brain Injuries; Traumatic Brain Injury; Physical Therapy Modalities; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Motor Activity Log

  The Motor Activity Log (MAL) is a structured interview intended to examine how much and how well the subject uses their more-affected arm outside of the laboratory setting.

  From baseline to 19 days

Secondary Outcomes (5)

• Accelerometry

  From baseline to 19 days

• Accelerometry

  From baseline to 12-months

• Motor Activity Log

  From baseline to 12-months

• Six-Minute Walk/Push Wheelchair Test

  From baseline to 19 days

• Six-Minute Walk/Push Wheelchair Test

  From baseline to 12-months

Study Arms (4)

Standard CI Therapy Group

EXPERIMENTAL

This group will receive Constraint-Induced Movement Therapy (CIMT) with the Standard Transfer Package (sTP).

Behavioral: Constraint-Induced Movement Therapy (CIMT); Behavioral: standard Transfer Package (sTP)

Enhanced CI Therapy Group

EXPERIMENTAL

This group will receive CIMT with the enhanced Transfer Package (eTP).

Behavioral: Constraint-Induced Movement Therapy (CIMT); Behavioral: enhanced Transfer Package (eTP)

Standard Fitness Training Group

ACTIVE COMPARATOR

This group will receive Lakeshore Enriched Fitness Training (LEFT) with the standard Transfer Package (sTP).

Behavioral: Lakeshore Enriched Fitness Training (LEFT); Behavioral: standard Transfer Package (sTP)

Enhanced Fitness Training Group

ACTIVE COMPARATOR

This group will receive LEFT with the enhanced Transfer Package (eTP)

Behavioral: Lakeshore Enriched Fitness Training (LEFT); Behavioral: enhanced Transfer Package (eTP)

Interventions

Constraint-Induced Movement Therapy (CIMT) BEHAVIORAL

Constraint-Induced Movement Therapy (CIMT) is a form of physical rehabilitation based on basic research in behavioral psychology and behavioral neuroscience. The therapy will be given on an outpatient basis for 3.5 hours/day for 10 consecutive weekdays. This treatment has four components: 1. intensive training in use of the more-affected arm; 2. organization of this training following shaping principles, which involve frequent positive feedback and progressively increasing the demand of the task in small increments; 3. discouraging use of the less-affected arm by placing the hand in a padded safety mitt, and 4. a set of behavioral procedures, known as the Transfer Package, for transferring gains from the treatment to real-world setting. In this study, two forms of the Transfer Package, standard and enhanced, will be used and form a separate factor (see below).

Also known as: CI therapy

Enhanced CI Therapy Group; Standard CI Therapy Group

Lakeshore Enriched Fitness Training (LEFT) BEHAVIORAL

This treatment will given on an outpatient basis for 3.5 hours per day for 10 consecutive weekdays. It will consist of the following components: general fitness exercises (largely lower extremity), sports and recreation (land and water-based); adapted Yoga; breathing exercises and postural control, movement to music, massage therapy, meditation and Progressive Muscle Relaxation (PMR).

Enhanced Fitness Training Group; Standard Fitness Training Group

standard Transfer Package (sTP) BEHAVIORAL

This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. The sTP is a set of behavioral procedures for transferring gains from the treatment setting to real-world. The procedures when the sTP is applied to CIMT include negotiating a behavioral contract with the patient and caregiver, when available, about use of each arm during the treatment period, keeping a daily diary on arm use, completing a structured interview about use of the more-affected arm in daily, problem solving about perceived barriers to use of the more-affected arm outside the treatment setting during treatment, and four weekly follow-up phone calls to assess use of the more-affected arm and problem solve about any remaining barriers perceived to its use. The sTP when applied to the LEFT intervention will have parallel components that target engagement in fitness activities and overcoming perceived barriers to fitness in the home.

Standard CI Therapy Group; Standard Fitness Training Group

enhanced Transfer Package (eTP) BEHAVIORAL

This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. It is an enhanced form of the sTP. The enhancements include a computerized version of the daily diary, cues to be placed in patients' homes to prompt engagement in desired activities, and additional follow-up phone calls.

Enhanced CI Therapy Group; Enhanced Fitness Training Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Motor criteria will be made using an impairment-level system for characterizing the severity of an upper-extremity (UE) motor deficit based on Active Range of Motion (AROM). All UE motor criteria determinations will be made with the subject sitting. The more-affected forearm will be resting on a supporting surface (e.g. arm of chair) to allow for maximum wrist flexion with gravity. This study will treat patients at levels of Grade 2 (mild/moderate impairment) and Grade 3 (moderate impairment).
• Extend against gravity at least 10 degrees at the wrist from a fully flexed starting position
• Extend two or more fingers at least 10 degrees at the metacarpophalangeal (MP) joint and either the proximal or distal interphalangeal (IP) joints
• Extend or abduct the thumb at least 10 degrees
• Extend the elbow at least 20 degrees from a 90 degree flexed starting position
• Flex and abduct the shoulder at least 45 degrees
• Extend against gravity at least 20 degrees at the wrist from a fully flexed starting position
• Extend all fingers at least 10 degrees at the MP joint and either the proximal or distal IP joints
• Extend or abduct the thumb at least 10 degrees
• Extend the elbow at least 20 degrees from a 90 degree flexed starting position
• Flex and abduct the shoulder at least 45 degrees
• Additionally, subjects must have substantially reduced use of the extremity in the activities of daily living as indicated by a score of less than 2.5 on the Motor Activity Log (MAL).
• Note: Each movement described above must be repeated 3 times in 1 minute.

You may not qualify if:

• Those \< 3 months post-TBI.
• Excessive UE spasticity.
• Insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).
• Participation in any experimental drug field study
• Botox injections to the more-affected UE less than 3 months prior to participation
• Baclofen or Dantrium taken orally at the time of study
• Mini-Mental Status Exam (MMSE) score below 20.
• Concurrent participation in any formal physical rehabilitation program or clinical trial.
• Excessive pain in any joint of the more-affected extremity that could limit ability to cooperate with the intervention (based on clinical judgment).
• Serious, uncontrolled medical problems (e.g., cardiovascular, severe rheumatoid arthritis, serious joint deformity of arthritic origin, symptomatic cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, uncontrolled epilepsy) as judged by the Medical Director.
• Other neurological or musculoskeletal conditions affecting UE function.
• Unable to read or speak English.
• Inadequate communication skills, i.e., not able to reliably understand questions or not able to express needs or report own behavior, to participate in study based on clinical judgment.
• Substantial use of the more-affected arm in daily life as reflected by a Motor Activity Log score \> 2.5.
• Pain that interferes with use of the more-affected arm based on clinical judgment.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (4)

• Taub E, Miller NE, Novack TA, Cook EW 3rd, Fleming WC, Nepomuceno CS, Connell JS, Crago JE. Technique to improve chronic motor deficit after stroke. Arch Phys Med Rehabil. 1993 Apr;74(4):347-54.

  PMID: 8466415 BACKGROUND

• Taub E, Uswatte G, King DK, Morris D, Crago JE, Chatterjee A. A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Stroke. 2006 Apr;37(4):1045-9. doi: 10.1161/01.STR.0000206463.66461.97. Epub 2006 Mar 2.

  PMID: 16514097 BACKGROUND

• Shaw SE, Morris DM, Uswatte G, McKay S, Meythaler JM, Taub E. Constraint-induced movement therapy for recovery of upper-limb function following traumatic brain injury. J Rehabil Res Dev. 2005 Nov-Dec;42(6):769-78. doi: 10.1682/jrrd.2005.06.0094.

  PMID: 16680614 BACKGROUND

• Morris DM, Taub E, Mark VW, Liu W, Brenner L, Pickett T, Stearns-Yoder K, Bishop-McKay S, Taylor A, Reder L, Adams T, Rimmer J, Dew D, Szaflarski J, Womble B, Stevens L, Rothman D, Uswatte G. Protocol for a Randomized Controlled Trial of CI Therapy for Rehabilitation of Upper Extremity Motor Deficit: The Bringing Rehabilitation to American Veterans Everywhere Project. J Head Trauma Rehabil. 2019 Jul/Aug;34(4):268-279. doi: 10.1097/HTR.0000000000000460.

  PMID: 30608308 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Injuries

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Edward Taub, Ph.D.

  CI Therapy Research Group and Taub Training Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2015
• First Posted: January 15, 2015
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: April 24, 2019
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)