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

19 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

16

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Ander: Mirror Therapy
Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
Andere namen:
  • MT
  • Mirror Box Therapy
  • Mirror Feedback Therapy
Experimenteel: 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).
Ander: Modified Constraint-Induced Movement Therapy
Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.
Andere namen:
  • mCIMT

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Independence Measure (FIM)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Other Pre-Specified
Tijdsspanne: 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)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Nisa Kiliç Koçak

Medewerkers

Ondokuz Mayıs University

Onderzoekers

  • Studie directeur: BİRCAN YÜCEKAYA, Ondokuz Mayıs University

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

19 februari 2026

Primaire voltooiing (Geschat)

20 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

19 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

19 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

19 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • OMÜ KAEK 2025/640

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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