Mirror Therapy Education for Acute Stroke Patients

February 11, 2021 updated by: Health Sciences North Research Institute

Effectiveness of Patient Education on Mirror Therapy to Improve Upper Extremity Function in Acute Stroke Patients

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
: 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 Measures

Outcome Measure
Measure Description
Time Frame
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.
: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Sciences North Research Institute

Collaborators

NORTHERN ONTARIO ACADEMIC MEDICINE ASSOCIATION (NOAMA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

September 2, 2020

First Posted (Actual)

September 9, 2020

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-20-15

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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