Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury

Craig Hospital1 site in 1 country62 target enrollmentApril 2013

ConditionsTraumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Traumatic Brain Injury
Sponsor: Craig Hospital
Enrollment: 62
Locations: 1
Primary Endpoint: Change from Baseline on Community Balance and Mobility (CB&M)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2013

End Date

December 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Craig Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change from Baseline on Balance Evaluation Systems Test (BESTest)(Baseline, 6weeks, 12weeks, 24weeks)
Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)(Baseline, 6weeks, 12weeks, 24weeks)
Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)(Baseline, 6 weeks, 12weeks, 24weeks)