Mirror Therapy Education for Acute Stroke Patients

• ClinicalTrials.gov Identifier: NCT04542772
• Recruitment Status: Not yet recruiting
• First Posted: September 9, 2020
• Last Update Posted: February 15, 2021
• Sponsor: Health Sciences North Research Institute
• Collaborator: NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)
• Information provided by (Responsible Party): Health Sciences North Research Institute

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?

Condition or disease	Intervention/treatment	Phase
Stroke, Acute	Other: Mirror Therapy; Other: Regular Rehabilitation	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients
• Estimated Study Start Date: May 2021
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Mirror Therapy + Standard of Care; Participants in this group will receive standard of care based on their needs along with mirror therapy education.	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.; Other: Regular Rehabilitation; Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.
Active Comparator: Standard of Care; Participants in this group will receive only standard of care based on their needs.	Other: Regular Rehabilitation; Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.

Outcome Measures

Primary Outcome Measures :

1. Fugl-Meyer Assessment scale [ 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. ]
   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.
2. Wolf Motor Function Test [ 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 ]
   Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Venkadesan Rajendran, PhD; 1-866-469-0822; vrajendran@hsnsudbury.ca

Contact: Padma Puranam, MD; 1-866-469-0822; ppuranam@hsnsudbury.ca

Sponsors and Collaborators

Health Sciences North Research Institute

NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rajendran V, Jeevanantham D, Larivière 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.

• Responsible Party: Health Sciences North Research Institute
• ClinicalTrials.gov Identifier: NCT04542772
• Other Study ID Numbers: C-20-15
• First Posted: September 9, 2020
• Last Update Posted: February 15, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases