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
About this trial
This is an interventional health services research trial for Stroke, Acute
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.
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
NCT ID
NCT04542772
First Posted
August 26, 2020
Last Updated
February 11, 2021
Sponsor
Health Sciences North Research Institute
Collaborators
NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
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
Learn more about this trial
Mirror Therapy Education for Acute Stroke Patients
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