Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectivenes of a home-based physical therapy program designed to improve balance following traumatic brain injury by incorporating the use of a virtual reality system.

Official Title
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Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Virtual Reality Based Exercise
* Behavioral: Standard Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has sustained a documented TBI that required an inpatient rehabilitation program; is at least one year post TBI; is at least 18 and no more than 64 years of age at the time of enrollment; is English or Spanish speaking is at least three months beyond completion of formal PT, including acute inpatient rehabilitation, outpatient and home-based therapy; provides written medical clearance for participation in an in-home balance exercise program; ambulates independently within the home (with assistive devices and/or orthotics as needed); has active range of motion of bilateral upper extremities of at least 90 degrees of abduction to allow for control of the VR system; completes a 15 minute trial using a VR system in the absence of a negative physical or behavioral reaction; self-reports ongoing balance deficits and demonstrate such deficits by scoring at or below one standard deviation above the mean (75 or below) on the CB&M; and provides informed consent, or has a guardian available to provide consent. Exclusion Criteria: has a history of another medical illness or neurological disorder which may affect balance; has experienced a seizure within the last year; has a history of psychiatric disorder requiring hospitalization; is currently participating in another RCT; is currently using VR technology to address specific balance goals; is unable to travel to Craig for assessments throughout the study period; is unable to communicate effectively to complete standardized assessments; has cognitive impairment that precludes completion of baseline testing; is unavailable to participate in 12 continuous weeks of therapy; has no access to television able to connect to VR-gaming system; and reports inadequate space required for VR-gaming system sensors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Based Exercise<br> | Behavioral: Virtual Reality Based Exercise<br>* A structured, individually tailored, protocol driven, reproducible therapeutic intervention. The study intervention will consist of individually prescribed selections from three off-the-shelf VR games that target the type and severity of balance deficits elicited during the completion of a baseline assessment. Participants randomized to receive this intervention will be assigned a home balance program that utilizes an Xbox Kinect system to provide balance activities.<br>|
| Active Comparator: Standard Exercise<br> | Behavioral: Standard Exercise<br>* An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Community Balance and Mobility (CB&M) | Specifically developed to assess balance function for individuals with TBI. Includes 13 balance based activites such as single leg standing, tandem walking, hopping, running, descending stairs. | Baseline, 6-weeks, 12 weeks, 24weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline on Balance Evaluation Systems Test (BESTest) | Used to evaluate balance system function. Movement characteristics and timed criteria are used to rate 36 items on a scale of 0 (maximum limitation) to 3 (within normal limits). | Baseline, 6weeks, 12weeks, 24weeks | 
| Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC) | Used to assess fear of falling, the ABC scale includes 16 items that describe everyday community activities and which are scored on a scale of 0 (no confidence) to 100 (complete confidence). | Baseline, 6weeks, 12weeks, 24weeks | 
| Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O) | This 17-item assessment of community participation will be used to measure overall societal participation. | Baseline, 6 weeks, 12weeks, 24weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic brain injury, balance deficits, virtual reality, home-based therapy