Assessment and Rehabilitation of Central Sensory Impairments for Balance in mTBI

Not Applicable

Completed

• Conditions: Brain Injury
• Interventions: Behavioral: Vestibular Rehabilitation + audio biofeedback; Behavioral: Vestibular Rehabilitation

• Registration Number: NCT02748109
• Lead Sponsor: Oregon Health and Science University

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Study Start: 2016-05-11
• Primary Completion: 2019-04-11
• Study Completion: 2019-06-24
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• have a diagnosis of mTBI based upon Veterans Health Administration (VHA)/Department of Defense (DoD) criteria with persisting symptoms >3 months post injury
• have minimal cognitive impairment; a score between 0 and 8 on the Short Blessed test for cognitive function
• may have or not had a loss of consciousness (LOC) with their initial injury

-OR-

• have no recent history of mTBI or brain injury and related complaints

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Exclusion Criteria

• have had or currently have any other injury, medical, substance or neurological illness that could potentially explain balance deficits (e.g., Central Nervous System disease, stroke, moderate TBI, lower extremity amputation)
• meet criteria for moderate to severe substance use disorder within the past month, as defined by Diagnostic and Statistical Manual (DSM-V)
• display behavior that would significantly interfere with validity of data collection or safety during study
• be in significant pain during the evaluation (5/10 by patient subjective report)
• be a pregnant female (balance considerations)
• have past history of peripheral vestibular pathology or ocular motor deficits
• have significant hearing loss that would interfere with the use of an auditory biofeedback device; hearing loss no worse than 30 decibel (dB) HL (PTA 0.5-3 kHz), in better ear, with the difference in ears being less than 15 dB PTA
• be unable to abstain for 24 hours in advance of testing in the use medications that might impair their balance (meclizine, scopolamine, benzodiazepines such as Valium, sedatives such as Ambien, narcotic pain medications, and antihistamines)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vestibular Rehabilitation + audio biofeedback	Vestibular Rehabilitation + audio biofeedback	Vestibular rehabilitation paired with audio biofeedback
Vestibular Rehabilitation	Vestibular Rehabilitation	Vestibular rehabilitation

Primary Outcome Measures

Name	Time	Method
Change in gait activity in the home as measured using an inertial sensor continuously in the home for a week before and after intervention.	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.

Secondary Outcome Measures

Name	Time	Method
Change in Sensory Orientation Test (SOT) Composite Score	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	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	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	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)	baseline	We will use this test to determine if it is a good predictor for rehabilitation outcomes
Dizziness Handicap Index (DHI)	baseline	This questionnaire takes approximately 10 minutes and asks if you become dizzy while performing various tasks.
PTSD Checklist	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	baseline	This questionnaire takes approximately 5 minutes and asks if you have pain and where that pain is located.
SIQR symptom Questionnaire	baseline	This questionnaire asks you to rate different symptoms on a sliding scale.
Sports Concussion Assessment Tool - 3 (SCAT-3) symptom questionnaire	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)	baseline	This questionnaire takes approximately 5 minutes and will ask questions regarding depression and personal emotions.
Short Form - 36	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	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	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	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	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 for a difference between the standard of care and audio biofeedback rehabilitation groups.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States