NCT05312905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

March 14, 2022

Last Update Submit

April 7, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mini-Mental State Examination

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

    changes after 8 weeks

  • 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.

    changes after 8 weeks

Secondary Outcomes (4)

  • Stroke-Specific Quality of Life Scale

    changes after 8 weeks

  • Beck Depression Scale

    changes after 8 weeks

  • Barthel Activity of Daily Living Scale

    changes after 8 weeks

  • Modified Ashworth Scale

    changes after 8 weeks

Study Arms (2)

Mirror Therapy

ACTIVE COMPARATOR

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+Cognitive Therapy

EXPERIMENTAL

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

Interventions

Mirror Therapy applied alone

Mirror Therapy

Mirror Therapy supported with Cognitive Exercises

Mirror+Cognitive Therapy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • a stroke history under the age of 40 not having a verbal or written communication level that cannot fulfill the study conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement TherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be included in the study and randomly divided into two groups using block randomization in Microsoft Excel-RANDOMISE 'RAND(WS)' function.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 6, 2022

Study Start

June 10, 2021

Primary Completion

December 20, 2021

Study Completion

January 7, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

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.

Locations