Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, balance deficits, virtual reality, home-based therapy
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.
Interventions
BEHAVIORALVirtual Reality Based Exercise
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.
BEHAVIORALStandard Exercise
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
Sponsors
Craig Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
Countries
United States
Outcome results
None listed