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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Standard Exercise	Standard Exercise	-
Virtual Reality Based Exercise	Virtual Reality Based Exercise	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline on Community Balance and Mobility (CB&M)	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 Outcome Measures

Name	Time	Method
Change from Baseline on Balance Evaluation Systems Test (BESTest)	Baseline, 6weeks, 12weeks, 24weeks	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).
Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)	Baseline, 6weeks, 12weeks, 24weeks	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).
Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)	Baseline, 6 weeks, 12weeks, 24weeks	This 17-item assessment of community participation will be used to measure overall societal participation.

Recruitment & Eligibility