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Mirror Therapy Education for Acute Stroke Patients

Primary Purpose

Stroke, Acute

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mirror Therapy
Regular Rehabilitation
Sponsored by
Health Sciences North Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Admitted with diagnosis of stroke with onset within two weeks
  • Medically stable
  • Able to follow directions
  • No severe cognitive impairments that could interfere with patient participation
  • Consent to treatment by patient
  • Alpha-Functional Independence Measure (Alpha-FIM) score of > 40

Exclusion Criteria:

  • Medical instability
  • Lack of motivation
  • Recurrent/ chronic stroke
  • Recent upper extremity musculoskeletal injuries with movement restrictions
  • Receptive or global aphasia
  • Delirium
  • Unilateral neglect
  • Visual field deficiency.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Mirror Therapy + Standard of Care

    Standard of Care

    Arm Description

    Participants in this group will receive standard of care based on their needs along with mirror therapy education.

    Participants in this group will receive only standard of care based on their needs.

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer Assessment scale
    Scores of < 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
    Wolf Motor Function Test
    Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.

    Secondary Outcome Measures

    Modified Barthel Index
    Assess Activity of Daily Living, Scores of <15 usually represents moderate disability and <10 usually represents severe disability.

    Full Information

    First Posted
    August 26, 2020
    Last Updated
    February 11, 2021
    Sponsor
    Health Sciences North Research Institute
    Collaborators
    NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04542772
    Brief Title
    Mirror Therapy Education for Acute Stroke Patients
    Official Title
    Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    September 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Health Sciences North Research Institute
    Collaborators
    NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke, Acute

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mirror Therapy + Standard of Care
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive standard of care based on their needs along with mirror therapy education.
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive only standard of care based on their needs.
    Intervention Type
    Other
    Intervention Name(s)
    Mirror Therapy
    Intervention Description
    Participants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed.
    Intervention Type
    Other
    Intervention Name(s)
    Regular Rehabilitation
    Intervention Description
    Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer Assessment scale
    Description
    Scores of < 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.
    Time Frame
    Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.
    Title
    Wolf Motor Function Test
    Description
    Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.
    Time Frame
    : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks
    Secondary Outcome Measure Information:
    Title
    Modified Barthel Index
    Description
    Assess Activity of Daily Living, Scores of <15 usually represents moderate disability and <10 usually represents severe disability.
    Time Frame
    : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Admitted with diagnosis of stroke with onset within two weeks Medically stable Able to follow directions No severe cognitive impairments that could interfere with patient participation Consent to treatment by patient Alpha-Functional Independence Measure (Alpha-FIM) score of > 40 Exclusion Criteria: Medical instability Lack of motivation Recurrent/ chronic stroke Recent upper extremity musculoskeletal injuries with movement restrictions Receptive or global aphasia Delirium Unilateral neglect Visual field deficiency.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Venkadesan Rajendran, PhD
    Phone
    1-866-469-0822
    Email
    vrajendran@hsnsudbury.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Padma Puranam, MD
    Phone
    1-866-469-0822
    Email
    ppuranam@hsnsudbury.ca

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34243808
    Citation
    Rajendran V, Jeevanantham D, Lariviere C, Singh RJ, Zeman L, Papuri P. Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol. Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.
    Results Reference
    derived

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    Mirror Therapy Education for Acute Stroke Patients

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