Status:
COMPLETED
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Lead Sponsor:
Craig Hospital
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-64 years
Phase:
NA
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 re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01794585
Start Date
April 1 2013
End Date
December 1 2017
Last Update
February 6 2018
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113