Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Status
Completed
Conditions
Traumatic Brain Injury
Treatments
Behavioral: Standard Exercise
Behavioral: Virtual Reality Based Exercise
Details and patient eligibility
About
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.
Enrollment
62 patients
Sex
All
Ages
18 to 64 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
62 participants in 2 patient groups
Virtual Reality Based Exercise
Experimental group
Treatment:
Behavioral: Virtual Reality Based Exercise
Standard Exercise
Active Comparator group
Treatment:
Behavioral: Standard Exercise
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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