Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794585
|United States, Colorado|
|Englewood, Colorado, United States, 80113|