Clinical Trial: Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI

Brief 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 Summary:

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 me
Sponsor: Oregon Health and Science University

Current Primary Outcome: Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention. [ Time Frame: before and after 6 weeks of intervention ]

An APDM movement monitor will be worn around the waist to gather information on local activity during the day.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Sensory Orientation Test (SOT) Composite Score [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline SOT composite score with the post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline mBESS measures using inertial sensors and the clinical scoring method looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Change in dynamic gait coordination [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare subjects symptoms using the SCAT-3 symptom log looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Automated Neuropsychological Assessment Metrics (ANAM) [ Time Frame: baseline ]
    We will use this test to determine if it is a good predictor for rehabilitation outcomes
  • Dizziness Handicap Index (DHI) [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
  • PTSD Checklist [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and is a list of problems and complaints some people have in response to stressful life experiences.
  • Pain Location Inventory [ Time Frame: baseline ]
    This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
  • SIQR symptom Questionnaire [ Time Frame: baseline ]
    This questionnaire asks you to rate different symptoms on a sliding scale.
  • Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire [ Time Frame: Every session ]
    This questionnaire takes approximately 5 minutes and asks you to rate 22 different symptoms on a scale between zero and six.
  • Becks Depression Inventory (BDI) [ Time Frame: baseline ]
    This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
  • Short Form - 36 [ Time Frame: baseline ]
    This questionnaire will take approximately 10 minutes and covers 36 questions about daily living and how your symptoms have or have not changed over certain time periods.
  • Neurobehavioral Symptom Inventory [ Time Frame: baseline ]
    This questionnaire takes approximately 10 minutes and goes through commons symptoms after traumatic brain injury (such as nausea and blurred vision) and asks you to rate your symptoms.
  • Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wvis) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wvest) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
  • Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception [ Time Frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes ]
    We will compare baseline CSMI scores (Wprop) with post rehabilitation scores looking fo

    Original Secondary Outcome: Same as current

    Information By: Oregon Health and Science University

    Dates:
    Date Received: March 29, 2016
    Date Started: April 2016
    Date Completion: September 2019
    Last Updated: September 29, 2016
    Last Verified: September 2016