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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
University of Guelph
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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

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