The Brave Initiative: Bringing Rehabilitation to American Veterans in an Enriched Environment
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

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.
    

Detailed description: 
      The proposed project is a prospective, randomized, controlled, single-blind study comparing
      the motor improvements resulting from Constraint-Induced Movement Therapy (CIMT) and
      Lakeshore Enriched Fitness Training (LEFT) for traumatic brain injury (TBI) in veterans and
      civilians. Over the course of two years, there will be a total of 80 subjects randomly
      assigned to 4 conditions. Treatment, testing, and follow-up testing will be carried out in
      the first 3 grant years and the 1-year follow-up will be completed in the fourth year.
      Clinical testing will be conducted at pre-treatment, post-treatment, and 1-year follow-up.
      Longitudinal neuroimaging studies to determine the treatment change in white matter, grey
      matter, and functional brain connectivity will be carried out across the above-noted time
      points by different diffusion tensor imaging (DTI) analysis variants, voxel-based morphometry
      (VBM) analysis of structural magnetic resonance imaging (MRI) scans, analysis of resting
      state functional MRI (fMRI), and analysis of fMRI during hand movement.

      The 80 study participants will be randomly assigned in equal numbers to 1 of 4 arms: CIMT
      with Standard Transfer Package (sTP), CIMT with Enhanced Transfer Package (eTP), LEFT with
      sTP or LEFT with eTP. Forty volunteers will be tested on average per year. The patients will
      be classified into mild/moderate (Grade 2) and moderate motor deficits (Grades 3); a
      classification made at the impairment level based on standard active range of motion (AROM)
      criteria (further elaborated in "Eligibility Criteria").

      The primary clinical outcome will be pre- to post-treatment change in a measure of use of the
      more-affected arm in daily life known as the Motor Activity Log. It is described in the
      outcomes section. As noted above, the response of the brain to the interventions will be
      examined using structural grey matter MRI analysis, DTI, and fMRI during resting state and
      during arm movement.

      Each participant will have the option of being accompanied by a caregiver (travel and living
      expenses paid for by the project). The caregiver will be asked to complete the MAL
      independently of the participant. The same questionnaire administered to the patient will be
      administered to the caregiver. In addition, the caregiver will be shown how to help the
      patient carry out the home practice exercises so that they can do this during treatment and
      afterwards (if they remain in close contact with the participant).
    

Intervention name(s): Constraint-Induced Movement Therapy (CIMT); Lakeshore Enriched Fitness Training (LEFT); standard Transfer Package (sTP); enhanced Transfer Package (eTP)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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).; 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).; 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.; 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.
Other intervention name(s): CI therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
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