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

Official title

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

Overview

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.

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.

Interventions

• Other Mirror Therapy
  Mirror therapy protocols targeting upper extremity motor functions for 4 weeks.
• Other Modified Constraint-Induced Movement Therapy
  Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks.

Primary outcome measures

• Fugl-Meyer Assessment-Upper Extremity (FMA-UE) [Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)]
• Stroke Rehabilitation Assessment of Movement (STREAM) [Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)]

Secondary outcome measures (3)

• Functional Independence Measure (FIM) [Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)]
• Motor Activity Log-28 (MAL-28) [Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)]
• Impact on Participation and Autonomy (IPA) [Time frame: Baseline (pre-treatment) and 4 weeks (post-treatment)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Akay Special Education and Rehabilitation Center — Kastamonu

Publications

• 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

Identifiers

NCT: NCT07668349 · OMÜ KAEK 2025/640

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗