Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
Primary Purpose
Acquired Brain Injury Including Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Mirror Therapy
Traditional Mirror Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Brain Injury Including Stroke focused on measuring Acquired Brain Injury, Stroke Rehabilitation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Experimental Group
Control Group
Arm Description
Patients receiving Virtual Reality Mirror Therapy
Patients receiving Traditional Mirror Therapy
Outcomes
Primary Outcome Measures
Upper Extremity Function
To measure subjects upper extremity function via assessment scores pre and post treatment.
Secondary Outcome Measures
Upper Extremity Range of Motion
Arm position data recorded through the VR systems measured in millimeters.
Full Information
NCT ID
NCT02762058
First Posted
April 28, 2016
Last Updated
May 3, 2016
Sponsor
University of Guelph
Collaborators
Hamilton Health Sciences Corporation, Natural Sciences and Engineering Research Council, Canada
1. Study Identification
Unique Protocol Identification Number
NCT02762058
Brief Title
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
Official Title
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Guelph
Collaborators
Hamilton Health Sciences Corporation, Natural Sciences and Engineering Research Council, Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury Including Stroke
Keywords
Acquired Brain Injury, Stroke Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Patients receiving Virtual Reality Mirror Therapy
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Patients receiving Traditional Mirror Therapy
Intervention Type
Device
Intervention Name(s)
Virtual Reality Mirror Therapy
Other Intervention Name(s)
VMT, Occulus Rift, Microsoft Kinect
Intervention Description
Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.
Intervention Type
Procedure
Intervention Name(s)
Traditional Mirror Therapy
Other Intervention Name(s)
Mirror Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper Extremity Function
Description
To measure subjects upper extremity function via assessment scores pre and post treatment.
Time Frame
6-weeks
Secondary Outcome Measure Information:
Title
Upper Extremity Range of Motion
Description
Arm position data recorded through the VR systems measured in millimeters.
Time Frame
6-weeks
Other Pre-specified Outcome Measures:
Title
Mean Average Response Time
Description
Mean average response time to complete tasks measured in seconds.
Time Frame
6-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Johnson, BHSc(PT)
Phone
(905)521-2100
Email
johnsden@hhsc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie Buchko
Phone
(905)521-2100
Email
buchkbon@hhsc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hussein Abdullah, PhD
Organizational Affiliation
University of Guelph
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Virtual Reality Mirror Therapy for Those With Acquired Brain Injury: A Clinical Pilot Study
We'll reach out to this number within 24 hrs