Mirror Therapy in Stroke

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05312905
Collaborator
(none)
30
1
2
6.9
4.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mirror Therapy
  • Other: Mirror Therapy + Cognitive Therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Primary Purpose:
Treatment
Official Title:
Home-based Mirror Therapy and Cognitive Therapeutic Exercises After Stroke
Actual Study Start Date :
Jun 10, 2021
Actual Primary Completion Date :
Dec 20, 2021
Actual Study Completion Date :
Jan 7, 2022

Arms and Interventions

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.

Other: Mirror Therapy
Mirror Therapy applied alone

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.

Other: Mirror Therapy + Cognitive Therapy
Mirror Therapy supported with Cognitive Exercises

Outcome Measures

Primary Outcome Measures

  1. Mini-Mental State Examination [changes after 8 weeks]

    The Mini-Mental State Examination (MMSE) is a 30-point test. Higher values mean better performance.

  2. Fugl-Meyer Upper Extremity Motor Assessment [changes after 8 weeks]

    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

  1. Stroke-Specific Quality of Life Scale [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.

  2. Beck Depression Scale [changes after 8 weeks]

    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.

  3. Barthel Activity of Daily Living Scale [changes after 8 weeks]

    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.

  4. Modified Ashworth Scale [changes after 8 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Istanbul Turkey 34815

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Farzin Hajebrahimi, PhD, Principal Investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05312905
Other Study ID Numbers:
  • MirrorCog2021
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022