Clinical trial NCT01794585: Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Official title: Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury
balance deficits
virtual reality
home-based therapy
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: Change from Baseline on Community Balance and Mobility (CB&M)
timeFrame: Baseline, 6-weeks, 12 weeks, 24weeks
Secondary outcomes:
measure: Change from Baseline on Balance Evaluation Systems Test (BESTest)
timeFrame: Baseline, 6weeks, 12weeks, 24weeks
measure: Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)
timeFrame: Baseline, 6weeks, 12weeks, 24weeks
measure: Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)
timeFrame: Baseline, 6 weeks, 12weeks, 24weeks
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References:
citation: Tefertiller C, Hays K, Natale A, O'Dell D, Ketchum J, Sevigny M, Eagye CB, Philippus A, Harrison-Felix C. Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury. Arch Phys Med Rehabil. 2019 Aug;100(8):1409-1416. doi: 10.1016/j.apmr.2019.03.015. Epub 2019 Apr 19.