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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Craig Hospital
Sponsor:
Information provided by (Responsible Party):
Craig Hospital
ClinicalTrials.gov Identifier:
NCT01794585
First received: November 12, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Behavioral: Virtual Reality Based Exercise
Behavioral: Standard Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Craig Hospital:

Primary Outcome Measures:
  • Change from Baseline on Community Balance and Mobility (CB&M) [ Time Frame: Baseline, 6-weeks, 12 weeks, 24weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from Baseline on Balance Evaluation Systems Test (BESTest) [ Time Frame: Baseline, 6weeks, 12weeks, 24weeks ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC) [ Time Frame: Baseline, 6weeks, 12weeks, 24weeks ] [ Designated as safety issue: No ]
    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).

  • Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Baseline, 6 weeks, 12weeks, 24weeks ] [ Designated as safety issue: No ]
    This 17-item assessment of community participation will be used to measure overall societal participation.


Estimated Enrollment: 66
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtual Reality Based Exercise 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.
Active Comparator: Standard Exercise Behavioral: Standard Exercise
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794585

Contacts
Contact: Jeff Cuthbert, PhD 303-789-8028
Contact: Laura Beck, BS 303-789-8918

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
  More Information

No publications provided

Responsible Party: Craig Hospital
ClinicalTrials.gov Identifier: NCT01794585     History of Changes
Other Study ID Numbers: H133A120032-2
Study First Received: November 12, 2012
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
traumatic brain injury
balance deficits
virtual reality
home-based therapy

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 11, 2014