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

NCT ID: NCT01794585

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Based Exercise

Group Type: EXPERIMENTAL

Virtual Reality Based Exercise

Intervention Type: BEHAVIORAL

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

Group Type: ACTIVE_COMPARATOR

Standard Exercise

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard Exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31009598 (View on PubMed)

Other Identifiers

H133A120032-2

Identifier Type: -

Identifier Source: org_study_id