Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794585
• Other study ID #: H133A120032-2
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: February 5, 2018
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• Standard Exercise
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline on Community Balance and Mobility (CB&M)	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.	Baseline, 6-weeks, 12 weeks, 24weeks
Secondary	Change from Baseline on Balance Evaluation Systems Test (BESTest)	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).	Baseline, 6weeks, 12weeks, 24weeks
Secondary	Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)	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).	Baseline, 6weeks, 12weeks, 24weeks
Secondary	Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)	This 17-item assessment of community participation will be used to measure overall societal participation.	Baseline, 6 weeks, 12weeks, 24weeks