Back to resultsVirtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Based Exercise
Standard Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, balance deficits, virtual reality, home-based therapy
Eligibility 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.
Sites / Locations
- Craig Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual Reality Based Exercise
Standard Exercise
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change from Baseline on Balance Evaluation Systems Test (BESTest)
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)
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)
This 17-item assessment of community participation will be used to measure overall societal participation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01794585
Brief Title
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
Official Title
Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Craig Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, balance deficits, virtual reality, home-based therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Based Exercise
Arm Type
Experimental
Arm Title
Standard Exercise
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Based Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Exercise
Intervention Description
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
Primary Outcome Measure Information:
Title
Change from Baseline on Community Balance and Mobility (CB&M)
Description
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.
Time Frame
Baseline, 6-weeks, 12 weeks, 24weeks
Secondary Outcome Measure Information:
Title
Change from Baseline on Balance Evaluation Systems Test (BESTest)
Description
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).
Time Frame
Baseline, 6weeks, 12weeks, 24weeks
Title
Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)
Description
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).
Time Frame
Baseline, 6weeks, 12weeks, 24weeks
Title
Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)
Description
This 17-item assessment of community participation will be used to measure overall societal participation.
Time Frame
Baseline, 6 weeks, 12weeks, 24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31009598
Citation
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.
Results Reference
derived
Learn more about this trial
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
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