NCT01794585CompletedNot Applicable
Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Craig Hospital
- Enrollment
- 62
- Locations
- 2
- Primary Endpoint
- Change from Baseline on Community Balance and Mobility (CB&M)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard Exercise
Active Comparator
Intervention: Standard Exercise (Behavioral)
Virtual Reality Based Exercise
Experimental
Intervention: Virtual Reality Based Exercise (Behavioral)
Outcomes
Primary Outcomes
Change from Baseline on Community Balance and Mobility (CB&M)
Time Frame: Baseline, 6-weeks, 12 weeks, 24weeks
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.
Secondary Outcomes
- Change from Baseline on Balance Evaluation Systems Test (BESTest)(Baseline, 6weeks, 12weeks, 24weeks)
- Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)(Baseline, 6weeks, 12weeks, 24weeks)
- Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)(Baseline, 6 weeks, 12weeks, 24weeks)
Investigators
Study Sites (2)
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