- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05312905
Mirror Therapy in Stroke
April 7, 2022 updated by: Farzin Hajebrahimi, PhD, Istanbul Medipol University Hospital
Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke
Little is known about mirror therapy and cognitive exercises applied together in patients with stroke by means of telerehabilitation.
The aim of this study is to investigate the effects of home-based mirror therapy combined with cognitive exercises on upper extremity functions and cognition in adults with stroke and to compare these effects with mirror therapy alone.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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 Locations
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Istanbul, Turkey, 34815
- Istanbul Medipol University
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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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Age 40 years old and over having had a stroke having unilateral involvement having sufficient communication skills to answer oral and written questions and following instructions 20< points in MMSE
Exclusion Criteria:
a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mirror Therapy
Exercises including mirror therapy will be applied to the participants in the Mirror Therapy group.
The mirror will be placed in such a way that the affected extremity of the patient could not be seen behind the mirror and the healthy extremity would be in front of his eyes, the patient will perform the exercises indicated by the physiotherapist with his intact extremity, looking into the mirror.
The exercises will be performed in sessions lasting 60 minutes, 3 days a week, over 8 weeks.
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Mirror Therapy applied alone
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Experimental: Mirror+Cognitive Therapy
The participants in the Mirror+Cognitive Therapy will be given a cognitive task with the application of mirror therapy.
Cognitive tasks with mirror therapy will be applied in sessions lasting 60 minutes, 3 days a week, over 8 weeks.
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Mirror Therapy supported with Cognitive Exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-Mental State Examination
Time Frame: changes after 8 weeks
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The Mini-Mental State Examination (MMSE) is a 30-point test.
Higher values mean better performance.
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changes after 8 weeks
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Fugl-Meyer Upper Extremity Motor Assessment
Time Frame: changes after 8 weeks
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The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item.
A zero score is given for the item if the subject cannot do the task.
A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.
The total possible scale score is 226.
Higher scores mean better performance.
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changes after 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stroke-Specific Quality of Life Scale
Time Frame: changes after 8 weeks
|
Specific Quality Of Life scale (SSQOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
The original test consists of 49 items encompassing 12 domains.
Each item is ranked on a 5-point scale, with higher scores indicating better function.
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changes after 8 weeks
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Beck Depression Scale
Time Frame: changes after 8 weeks
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The Beck Depression Scale is a 21-item self-report inventory designed to assess the presence and severity in depressive symptoms.
Each item is rated on a 4-point Likert-type scale ranging from 0 to 3, based on the severity in the last two weeks.
Higher scores indicating worse level of depression.
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changes after 8 weeks
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Barthel Activity of Daily Living Scale
Time Frame: changes after 8 weeks
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The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing.
Eight factors are rated to produce an overall score on a point scale of 0 to 100.
Then, an assignment is given as "excellent" for 95 to 100 points; "good" for 84 to 94 points, "fair" for 65 to 83 points, or "poor" for less than 65 points, higher scores indicating better function.
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changes after 8 weeks
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Modified Ashworth Scale
Time Frame: changes after 8 weeks
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The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform.This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity).
The usage of this scale is easy; however, the results depend on the evaluator.
Higher scores indicating sever spasticity.
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changes after 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 10, 2021
Primary Completion (Actual)
December 20, 2021
Study Completion (Actual)
January 7, 2022
Study Registration Dates
First Submitted
March 14, 2022
First Submitted That Met QC Criteria
March 28, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MirrorCog2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data that support the findings of this study will be available on reasonable request from the Principle Investigator.
The data are not publicly available due to ethical issues.
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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