- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762058
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
May 3, 2016 updated by: Laura MacNeil, University of Guelph
The goal of this study is to investigate the effects of virtual reality based mirror therapy (VMT) on individuals with acquired brain injury when compared to a control group receiving traditional mirror therapy (TMT).
This is a randomized controlled pilot study in which patients with hemiplegia will be assigned to VMT or TMT and the impact on upper extremity function will be observed.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The investigators are currently running a mirror therapy pilot project in the Hamilton Health Sciences Rehabilitation Program.
Mirror therapy has been successfully used with people that have injuries such as strokes or other types of brain injuries that affect movement on one side of their body.
Mirror therapy involves placing a mirror over the affected limb and angling it to reflect the unaffected limb.
This creates a visual illusion that moving the unaffected limb also results in movement in the affected limb.
This is theorized to aid recovery of the motor system in the brain.
Virtual Reality (VR) can also be used with people with strokes and brain injuries and many studies of VR have shown positive results.
In this study, the investigators will combine VR and mirror therapy.
The investigators have designed a special new system that uses VR headset to make it appear that both limbs are moving when only the unaffected limb is moving.
The investigators are going to do this by having people complete virtual tasks wearing this specially programmed headset.
The tasks are everyday activities that a person might perform using two hands.
Ultimately, the investigators hope to determine whether there is any difference between VR mirror therapy and regular mirror therapy in improving upper limb function.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Denise Johnson, BHSc(PT)
- Phone Number: (905)521-2100
- Email: johnsden@hhsc.ca
Study Contact Backup
- Name: Bonnie Buchko
- Phone Number: (905)521-2100
- Email: buchkbon@hhsc.ca
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of stroke or brain injury, including ischemic or hemorrhagic strokes, confirmed by radio logical evidence and evidence suggesting injury primarily to one side and exhibited by hemiplegia
- their post injury time is between 2 weeks and 2 years
- patients are between the age of 16 and 65 years old
Exclusion Criteria:
- greater than stage 4 on the CMSA
- behavioral impairments that may prevent safe or consistent participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group
Patients receiving Virtual Reality Mirror Therapy
|
Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.
Other Names:
|
EXPERIMENTAL: Control Group
Patients receiving Traditional Mirror Therapy
|
Traditional Mirror Therapy system consisting of a mirror in which patients view their healthy limb over the affected to trick brain during dual motion tasks.
This therapy has been shown to improve upper extremity function in patients with acquired brain injury.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Extremity Function
Time Frame: 6-weeks
|
To measure subjects upper extremity function via assessment scores pre and post treatment.
|
6-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Extremity Range of Motion
Time Frame: 6-weeks
|
Arm position data recorded through the VR systems measured in millimeters.
|
6-weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Average Response Time
Time Frame: 6-weeks
|
Mean average response time to complete tasks measured in seconds.
|
6-weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Hussein Abdullah, PhD, University of Guelph
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (ANTICIPATED)
June 1, 2019
Study Completion (ANTICIPATED)
June 1, 2019
Study Registration Dates
First Submitted
April 28, 2016
First Submitted That Met QC Criteria
May 3, 2016
First Posted (ESTIMATE)
May 4, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 3, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1227
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Virtual Reality Mirror Therapy
-
CEU San Pablo UniversityCompleted
-
Abant Izzet Baysal UniversityEnrolling by invitationStroke | Upper Extremity Paralysis | Upper Extremity ParesisTurkey
-
Columbia UniversityRealiteer Corp.Completed
-
Chang Gung Memorial HospitalNot yet recruitingStroke | Cerebrovascular Disorders | Central Nervous System DiseasesTaiwan
-
Ataturk UniversityActive, not recruiting
-
Centre Hospitalier Universitaire de Saint EtienneRecruiting
-
Sahmyook UniversityCompletedStroke | Stroke Rehabilitation | Mirror Movement TherapyKorea, Republic of
-
National Cheng-Kung University HospitalRecruitingStroke | Rehabilitation | Virtual Reality | Mirror Movement TherapyTaiwan
-
Centre Hospitalier Régional d'OrléansCompleted
-
Charles University, Czech RepublicActive, not recruitingHealthy | Age of Probands 18 - 55 YearsCzechia