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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04542772
Other study ID # C-20-15
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2021
Est. completion date September 2021

Study information

Verified date February 2021
Source Health Sciences North Research Institute
Contact Venkadesan Rajendran, PhD
Phone 1-866-469-0822
Email vrajendran@hsnsudbury.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 36
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mirror Therapy
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.
Regular Rehabilitation
Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Health Sciences North Research Institute NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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.
Primary Wolf Motor Function Test Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels. : 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 Modified Barthel Index Assess Activity of Daily Living, Scores of <15 usually represents moderate disability and <10 usually represents severe disability. : 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
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