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Completed

NCT Number: NCT01794585

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard Exercise

Behavioral

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

Primary outcomes

  1. 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

  1. Change from Baseline on Balance Evaluation Systems Test (BESTest)

    Time frame: Baseline, 6weeks, 12weeks, 24weeks

    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).

  2. Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)

    Time frame: Baseline, 6weeks, 12weeks, 24weeks

    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).

  3. Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)

    Time frame: Baseline, 6 weeks, 12weeks, 24weeks

    This 17-item assessment of community participation will be used to measure overall societal participation.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 20, 2013
Registry last updated
Feb 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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