Trial record 18 of 72 for:    "balance impairment" OR "balance training" | Open Studies

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

This study is currently recruiting participants.
Verified August 2013 by Craig Hospital
Sponsor:
Information provided by (Responsible Party):
Craig Hospital
ClinicalTrials.gov Identifier:
NCT01794585
First received: November 12, 2012
Last updated: August 30, 2013
Last verified: August 2013
  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
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 30, 2013
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 April 17, 2014