Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
|ClinicalTrials.gov Identifier: NCT01794585|
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : February 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Behavioral: Virtual Reality Based Exercise Behavioral: Standard Exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
|Experimental: Virtual Reality Based Exercise||
Behavioral: Virtual 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.
|Active Comparator: Standard Exercise||
Behavioral: Standard Exercise
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
- 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.
- Change from Baseline on Balance Evaluation Systems Test (BESTest) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Baseline, 6 weeks, 12weeks, 24weeks ]This 17-item assessment of community participation will be used to measure overall societal participation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794585
|United States, Colorado|
|Englewood, Colorado, United States, 80113|