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

NCT01794585 | Completed

• 1 other identifier: H133A120032-2
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Keywords

traumatic brain injury; balance deficits; virtual reality; home-based therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Virtual Reality Based Exercise

EXPERIMENTAL

Behavioral: Virtual Reality Based Exercise

Standard Exercise

ACTIVE COMPARATOR

Behavioral: Standard Exercise

Interventions

Virtual Reality Based Exercise 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.

Virtual Reality Based Exercise

Standard Exercise BEHAVIORAL

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

Standard Exercise

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

Related Publications (1)

• 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.

  PMID: 31009598 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: February 20, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

US (1)