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

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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 Read More

Inclusion Criteria:

- 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).

• The minimum motor criterion (MMC) for inclusion in Grade 3 (moderate impairment) will be ability to:

  • 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

• The MMC for inclusion in Grade 2 (mild/moderate impairment) will be ability to:

  • 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.

Exclusion Criteria:

• Those < 3 months post-TBI.
• Excessive UE spasticity.
• Insufficient stamina to carry out the requirements of the therapy (based on clinical judgment).

• Medication (including psychoactive substances) will not be exclusionary except in the following cases: (If subjects are on other medications, the medications will be recorded and the possible effect on treatment outcome will be analyzed separately)

  • 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.
• A positive pregnancy test will exclude participants from MRI scanning, but would not exclude them from clinical treatment.