Traumatic Brain InjuryNCT01794585
Virtual Reality (VR) Treatment for Balance Problems in Traumatic Brain Injury (TBI)
A study testing Virtual Reality Based Exercise and Standard Exercise in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Virtual Reality Based Exercise and Standard Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Virtual Reality Based Exercise, Standard Exercise
- Keywords
- traumatic brain injury, balance deficits, virtual reality, home-based therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Based ExerciseBehavioural
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 ExerciseBehavioural
An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Based Exercise | Experimental | Not described Receives: Behavioral: Virtual Reality Based Exercise |
| Standard Exercise | Active comparator | Not described Receives: Behavioral: Standard Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6-weeks, 12 weeks, 24weeks
Secondary outcomes (3)
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).
Measured: Baseline, 6weeks, 12weeks, 24weeks
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).
Measured: Baseline, 6weeks, 12weeks, 24weeks
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.
Measured: Baseline, 6 weeks, 12weeks, 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794585
- Sponsor's protocol ID
- H133A120032-2
- Status last verified
- Feb 2018
- First submitted
- 12 Nov 2012
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31009598
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Virtual Reality (VR) Treatment for Chronic Balance Problems in Adults With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01794585
- Acronym / sponsor ID
- H133A120032-2
- Conditions
- Traumatic Brain Injury
- Keywords
- traumatic brain injury, balance deficits, virtual reality, home-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Based Exercise | Experimental | Behavioral: Virtual Reality Based Exercise |
| Standard Exercise | Active comparator | Behavioral: Standard Exercise |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Based ExerciseA 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. | Behavioural | Virtual Reality Based Exercise |
| Standard ExerciseAn individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components. | Behavioural | Standard Exercise |
Primary outcome
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.
3 secondary outcomes
Change from Baseline on Balance Evaluation Systems Test (BESTest)
Time frame: Baseline, 6weeks, 12weeks, 24weeks
Change from Baseline on Activity-specific, Behavior Confidence Scale (ABC)
Time frame: Baseline, 6weeks, 12weeks, 24weeks
Change from Baseline on Participation Assessment with Recombined Tools-Objective (PART-O)
Time frame: Baseline, 6 weeks, 12weeks, 24weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Derived from this study: PubMed 31009598Tefertiller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Based Exercise and Standard Exercise in people with Traumatic Brain Injury, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Community Balance and Mobility (CB&M) (time frame: Baseline, 6-weeks, 12 weeks, 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.