Effects of Modified Constraint-Induced Movement Therapy and Mirror Therapy in Hemiplegic Stroke

June 19, 2026 updated by: Nisa Kiliç Koçak

Comparison of the Effects of Modified Constraint-Induced Movement Therapy and Mirror Therapy Applied to the Upper Extremity on Motor Function, Participation, and Independence in Activities of Daily Living in Hemiplegic Stroke Patients: A Randomized Controlled Trial

The purpose of this study is to investigate and compare the effects of Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT) on upper extremity motor functions, activity participation, and independence in daily living activities among hemiplegic stroke patients. Participants diagnosed with stroke will be randomly assigned to intervention groups. The study aims to determine which therapeutic modality provides a higher contribution to the functional recovery of the paretic upper limb and overall quality of life.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale:

Upper extremity impairment is one of the most common and disabling consequences of stroke, severely limiting independence in daily living and restricting social participation. Neuroplasticity-based interventions, such as Modified Constraint-Induced Movement Therapy (mCIMT) and Mirror Therapy (MT), are widely recognized for their potential to facilitate cortical reorganization. However, comparative evidence regarding their specific impacts on multi-dimensional recovery patterns (motor function vs. activity integration) remains limited. This study aims to provide a comprehensive head-to-head comparison of mCIMT and MT in a structured clinical environment.

Methodology & Protocol:

This study is designed as a prospective, randomized, controlled, single-blind clinical trial. Following formal ethical approval (OMU KAEK 2025/640) and obtained informed consent, eligible hemiplegic stroke patients will be screened and randomly allocated into the intervention arms.

All participants will receive standard medical care and baseline conventional physical therapy. The intervention groups will be structured as follows:

Modified Constraint-Induced Movement Therapy (mCIMT) Group: Participants will have their unaffected upper extremity constrained using a specialized mitt or splint for a designated period daily, combined with intensive, repetitive, task-oriented training of the paretic upper limb.

Mirror Therapy (MT) Group: Participants will perform structured, bilateral upper extremity tasks while observing the non-affected limb's movements in a mirror box, creating a visual illusion of normal movement in the paretic limb.

Outcome Measures:

Assessment sessions will be conducted at baseline (pre-treatment) and immediately following the completion of the intervention protocol (post-treatment) by a blinded assessor. Upper extremity motor functions will be evaluated using standardized neurological and functional scales. Secondary outcomes will include clinical assessments of activity participation and the level of independence achieved in activities of daily living.

Study Type

Interventional

Enrollment (Estimated)

16

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

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Kastamonu, Merkez, Turkey (Türkiye), 37100
        • Recruiting
        • Akay Special Education and Rehabilitation Center
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • * Diagnosis: Confirmed first ischemic or hemorrhagic stroke with clinical and neurological evaluation.

    • Time Since Stroke: 3 to 24 months post-stroke onset.
    • Hemiplegia: Significant motor deficit in the affected upper extremity.
    • Motor Function Level: Presence of mild to moderate motor impairment in the affected upper extremity (FMA-UE score appropriate for the application of modified CIMT and mirror therapy).
    • Cognitive Status: Adequate cognitive capacity to understand and follow the study protocols (Mini-Mental State Examination score of 20 or above).
    • Visual Perception: Adequate visual perception to perform mirror therapy.
    • Comorbidities: Absence of severe coexisting medical conditions that prevent participation (e.g., uncontrolled cardiovascular diseases, severe psychiatric disorders).
    • Prior Treatments: No prior intensive participation in the interventions investigated in this study (modified CIMT or mirror therapy).
    • Consent: Voluntary agreement to participate and signed informed consent form.

Exclusion Criteria:

  • * Uncontrolled diabetes or other metabolic disorders.

    • Progressive non-stroke neurological diseases (e.g., Parkinson's disease, multiple sclerosis).
    • Terminal illness or short life expectancy.
    • Severe cognitive impairment preventing comprehension or execution of the study protocols (e.g., advanced dementia).
    • Severe visual impairment that prevents mirror therapy application (e.g., uncorrected visual acuity loss, neglect).
    • Severe visuospatial perception disorders making it difficult to perceive or interpret the mirror image.
    • Absence or minimal level of active movement in the affected upper extremity (limiting the applicability of modified CIMT).
    • Significant motor deficit in the unaffected upper extremity.
    • Severe and uncontrolled spasticity in the upper extremity.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirror Therapy Group
Stroke patients in this group will receive mirror therapy in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training).
Other: Mirror Therapy
Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
Other Names:
  • MT
  • Mirror Box Therapy
  • Mirror Feedback Therapy
Experimental: Modified CIMT Group
Stroke patients in this group will receive modified Constraint-Induced Movement Therapy (modified CIMT) targeting the affected upper extremity, in addition to their routine rehabilitation program. The intervention will be administered face-to-face in a rehabilitation hall context. Assessments will be performed face-to-face at baseline (pre-training) and after the 4-week treatment period (post-training).
Other: Modified Constraint-Induced Movement Therapy
Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.
Other Names:
  • mCIMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time Frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The FMA-UE is an index used to assess sensorimotor function in stroke patients. It evaluates reflex activity, volitional movement, and coordination of the upper extremity. The total score ranges from 0 to 66, with higher scores indicating better upper extremity motor function.
Baseline (pre-treatment) and 4 weeks (post-treatment)
Stroke Rehabilitation Assessment of Movement (STREAM)
Time Frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The STREAM is a clinical measure of motor functioning for stroke patients. It evaluates upper limb movements, lower limb movements, and basic mobility. The total score ranges from 0 to 30 for each subscale, with higher scores reflecting better motor performance and mobility.
Baseline (pre-treatment) and 4 weeks (post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Independence Measure (FIM)
Time Frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The FIM is an 18-item instrument used to assess the physical and cognitive disability of patients and track their changes during rehabilitation. It measures independent performance in self-care, sphincter control, transfers, locomotion, communication, and social cognition. Total scores range from 18 to 126, where higher scores indicate greater functional independence.
Baseline (pre-treatment) and 4 weeks (post-treatment)
Motor Activity Log-28 (MAL-28)
Time Frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The MAL-28 is a semi-structured interview used to assess the real-world use of the affected upper extremity in stroke patients. It includes two subscales: the Amount of Use (AOU) and the Quality of Movement (QOM) across 28 daily activities. Scores for each subscale range from 0 to 5, with higher scores indicating more frequent or better quality of upper limb use in daily life.
Baseline (pre-treatment) and 4 weeks (post-treatment)
Impact on Participation and Autonomy (IPA)
Time Frame: Baseline (pre-treatment) and 4 weeks (post-treatment)
The IPA is a patient-reported outcome measure designed to assess perceived participation and autonomy in individuals with chronic conditions. It evaluates dimensions such as autonomy indoors/outdoors, family role, social relations, and work/education. Higher subscale scores reflect greater restrictions or poorer perceived participation and autonomy.
Baseline (pre-treatment) and 4 weeks (post-treatment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other Pre-Specified
Time Frame: Baseline (pre-treatment)
The MMSE is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. It is used as a screening tool in this study to ensure participants possess the adequate cognitive capacity (a score of 20 or above) to understand and follow the rehabilitation protocols.
Baseline (pre-treatment)
Modified Rankin Scale (mRS)
Time Frame: Baseline (pre-treatment)
The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of individuals who have suffered a stroke. It ranges from 0 (no symptoms at all) to 6 (dead), with lower scores indicating greater functional independence and less disability.
Baseline (pre-treatment)

Collaborators and Investigators

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

Sponsor

Nisa Kiliç Koçak

Collaborators

Ondokuz Mayıs University

Investigators

  • Study Director: BİRCAN YÜCEKAYA, Ondokuz Mayıs University

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 (Actual)

February 19, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMÜ KAEK 2025/640

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect participant confidentiality in accordance with institutional review board regulations and informed consent limitations.

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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