search
Back to results

Mirror Therapy in Stroke

Primary Purpose

Stroke, Cognitive Therapy, Telerehabilitation

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mirror Therapy
Mirror Therapy + Cognitive Therapy
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Mirror Therapy

Mirror+Cognitive Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mini-Mental State Examination
The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.
Fugl-Meyer Upper Extremity Motor Assessment
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.

Secondary Outcome Measures

Stroke-Specific Quality of Life Scale
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.
Beck Depression Scale
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.
Barthel Activity of Daily Living Scale
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.
Modified Ashworth Scale
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.

Full Information

First Posted
March 14, 2022
Last Updated
April 7, 2022
Sponsor
Istanbul Medipol University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05312905
Brief Title
Mirror Therapy in Stroke
Official Title
Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
January 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Therapy, Telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be included in the study and randomly divided into two groups using block randomization in Microsoft Excel-RANDOMISE 'RAND(WS)' function.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirror Therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mirror+Cognitive Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mirror Therapy
Intervention Description
Mirror Therapy applied alone
Intervention Type
Other
Intervention Name(s)
Mirror Therapy + Cognitive Therapy
Intervention Description
Mirror Therapy supported with Cognitive Exercises
Primary Outcome Measure Information:
Title
Mini-Mental State Examination
Description
The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.
Time Frame
changes after 8 weeks
Title
Fugl-Meyer Upper Extremity Motor Assessment
Description
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.
Time Frame
changes after 8 weeks
Secondary Outcome Measure Information:
Title
Stroke-Specific Quality of Life Scale
Description
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.
Time Frame
changes after 8 weeks
Title
Beck Depression Scale
Description
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.
Time Frame
changes after 8 weeks
Title
Barthel Activity of Daily Living Scale
Description
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.
Time Frame
changes after 8 weeks
Title
Modified Ashworth Scale
Description
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.
Time Frame
changes after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
ZIP/Postal Code
34815
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Mirror Therapy in Stroke

We'll reach out to this number within 24 hrs