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

NCT07668349 | Recruiting

• 1 other identifier: OMÜ KAEK 2025/640
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke,Hemiplegia

Keywords

Stroke Rehabilitation; Constraint-Induced Movement Therapy; Mirror Therapy; Upper Extremity

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer Assessment-Upper Extremity (FMA-UE)

  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)

  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 Outcomes (3)

• Functional Independence Measure (FIM)

  Baseline (pre-treatment) and 4 weeks (post-treatment)

• Motor Activity Log-28 (MAL-28)

  Baseline (pre-treatment) and 4 weeks (post-treatment)

• Impact on Participation and Autonomy (IPA)

  Baseline (pre-treatment) and 4 weeks (post-treatment)

Other Outcomes (2)

• Other Pre-Specified

  Baseline (pre-treatment)

• Modified Rankin Scale (mRS)

  Baseline (pre-treatment)

Study Arms (2)

Mirror Therapy Group

EXPERIMENTAL

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

Modified CIMT Group

EXPERIMENTAL

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

Interventions

Mirror Therapy OTHER

Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.

Also known as: Mirror Box Therapy, MT, Mirror Feedback Therapy

Mirror Therapy Group

Modified Constraint-Induced Movement Therapy OTHER

Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.

Also known as: mCIMT

Modified CIMT Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \* 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.

You may not qualify if:

• \* 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.

Sponsors & Collaborators

• Nisa Kiliç Koçak: lead
• Ondokuz Mayıs University: collaborator

Study Sites (1)

Akay Special Education and Rehabilitation Center

Kastamonu, Merkez, 37100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Saygili F, Guclu-Gunduz A, Eldemir S, Eldemir K, Ozkul C, Gursoy GT. Effects of modified-constraint induced movement therapy based telerehabilitation on upper extremity motor functions in stroke patients. Brain Behav. 2024 Jun;14(6):e3569. doi: 10.1002/brb3.3569.

  PMID: 38873866 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• BİRCAN YÜCEKAYA

  Ondokuz Mayıs University

  STUDY DIRECTOR

Central Study Contacts

NİSA KILIÇ KOÇAK, Msc Student

CONTACT

+905455932547; nisakilicas12@gmail.com

BİRCAN YÜCEKAYA, Asst.Prof.Dr

CONTACT

+905056226099; bircan.yucekaya@omu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master's Student Nisa Kılıç KOÇAK

Model Details: The sample size was calculated using PASS 15.0 based on an effect size of Cohen's $d = 0.468$ obtained from the study by Hsieh et al. (2014), an alpha level of 0.05, and a power of 80%. As a result of the power analysis, a minimum of 8 participants per group, making a total of 16 participants, is required.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: February 19, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)