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

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ClinicalTrials.gov Identifier: NCT01794585
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Craig Hospital

November 12, 2012
February 20, 2013
February 6, 2018
April 2013
December 2017   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01794585 on ClinicalTrials.gov Archive Site
  • 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).
  • 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).
  • 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.
Same as current
Not Provided
Not Provided
 
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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.
  • Behavioral: Standard Exercise
    An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
  • Experimental: Virtual Reality Based Exercise
    Intervention: Behavioral: Virtual Reality Based Exercise
  • Active Comparator: Standard Exercise
    Intervention: Behavioral: Standard Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
62
66
December 2017
December 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 64 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01794585
H133A120032-2
No
Not Provided
Not Provided
Craig Hospital
Craig Hospital
Not Provided
Not Provided
Craig Hospital
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP