Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI
Condition: Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      Our central hypothesis is that chronic balance deficits after mild traumatic brain injury
      (mTBI) result from impairments in central sensorimotor integration (CSMI) that may be helped
      by rehabilitation. There are two objectives of this proposal; the first objective is to
      characterize balance deficits in people with mTBI. The second objective is to use a novel
      auditory bio-feedback (ABF) device to improve measures central sensorimotor integration and
      balance control.
    

Detailed description: 
      Objectives: This study as two parts: 1) Cross-sectional study (Aim I: Balance Assessment) to
      identify and characterize maladaptive balance control strategies after mTBI compared to
      healthy controls and 2) Interventional randomized pilot study (Aim II: Balance
      Rehabilitation) using a novel ABF rehabilitation technique to ameliorate maladaptive balance
      control strategies after TBI. Subjects in Aim II will be a subset from Aim I and studies will
      occur simultaneously.

      Plan: The proposed 4-year study has two parts: 1) Cross-sectional study (Aim I: Balance
      Assessment) to identify and characterize maladaptive balance control strategies after mTBI
      compared to healthy controls and 2) Interventional randomized pilot study (Aim II: Balance
      Rehabilitation) using a novel ABF rehabilitation technique to ameliorate maladaptive balance
      control strategies after TBI. Subjects in Aim II will be a subset from Aim I and studies will
      occur simultaneously.

      Methods: I) Balance Assessment: To characterize balance deficits in people with mTBI who have
      chronic, non-resolving balance deficits compared to healthy control subjects without a
      history of mTBI. We hypothesize that a) objective measures of central sensorimotor
      integration, static and dynamic balance will better distinguish people with mTBI from control
      subjects than clinical measures, b) a subset of people with mTBI will have abnormal central
      sensori-motor integration (CSMI) test measures, even without peripheral vestibular or ocular
      motor deficits c) the relationship between poorer static/dynamic balance performance and mTBI
      is regulated/mediated by CSMI. We will test 130 subjects between the ages of 18 and 60; 65
      with chronic (> 3 months) mTBI and non-resolving balance deficits and 65 healthy age and
      gender matched control subjects without a history of mTBI. We will obtain objective measures
      of static and dynamic balance using wearable inertial sensors and determine how these
      measures relate to central sensorimotor integration. We will also obtain laboratory measures
      of peripheral vestibular function and ocular motor function to help classify people and to
      consider as potential covariates in rehabilitation efficacy.

      II) Balance Rehabilitation: To determine the efficacy of a novel, ABF balance rehabilitation
      program to improve central sensorimotor integration, static and dynamic balance, and
      functional activity in patients with chronic mTBI. We hypothesize that a) CSMI scores will
      improve with rehabilitation and ABF will increase the improvement of CSMI scores beyond the
      standard of care, b) ABF intervention will improve objective summary measures of balance and
      c) people with central sensorimotor integration impairment will show sustained improvement in
      CSMI scores and balance after rehabilitation. We will randomize 40 subjects between the ages
      of 21 and 50; 65 with chronic (> 3 months) mTBI and non-resolving balance deficits from Aim I
      who have abnormal CSMI into either the ABF rehabilitation group or the standard of care
      group. People will be tested before and after a 6-week intervention period and again 6 week
      later to determine long-term changes. Normal/abnormal vestibular and ocular motor function
      will be used as covariates to determine if peripheral deficits affect the efficacy of ABF
      rehabilitation.
    

Intervention name(s): Vestibular Rehabilitation + audio biofeedback; Vestibular Rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.; Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Therapy; Balance Disorder; Concussion; Mild Traumatic Brain Injury