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.
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 18 and 60; 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
Oregon Health and Science University
Portland, Oregon, United States
Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.
An APDM movement monitor will be worn around the waist to gather information on local activity during the day.
Time frame: before and after 6 weeks of intervention
Change in Sensory Orientation Test (SOT) Composite Score
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.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Change in Modified Balance Error Scoring System (mBESS) instrumented and non-instrumented scores
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.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Change in dynamic gait coordination
We will compare baseline gait measures using inertial sensors looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Change in Sport Concussion Assessment Tool - 3rd edition (SCAT-3) symptoms questionnaire
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.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
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Automated Neuropsychological Assessment Metrics (ANAM)
We will use this test to determine if it is a good predictor for rehabilitation outcomes
Time frame: baseline
Dizziness Handicap Index (DHI)
This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
Time frame: baseline
PTSD Checklist
This questionnaire takes approximately 10 minutes and is a list of problems and complaints some people have in response to stressful life experiences.
Time frame: baseline
Pain Location Inventory
This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
Time frame: baseline
SIQR symptom Questionnaire
This questionnaire asks you to rate different symptoms on a sliding scale.
Time frame: baseline
Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire
This questionnaire takes approximately 5 minutes and asks you to rate 22 different symptoms on a scale between zero and six.
Time frame: Every session
Becks Depression Inventory (BDI)
This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
Time frame: baseline
Short Form - 36
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.
Time frame: baseline
Neurobehavioral Symptom Inventory
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.
Time frame: baseline
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vision
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.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; vestibular
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.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes
Change in Central Sensorimotor Integration (CSMI) Weighting Scores; proprioception
We will compare baseline CSMI scores (Wprop) with post rehabilitation scores looking for a difference between the standard of care and audio biofeedback rehabilitation groups.
Time frame: Subjects will be tested before and after a 6-week intervention period and again 6 weeks later to determine long-term changes