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NCT Number: NCT07668349

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akay Special Education and Rehabilitation Center

Kastamonu, Merkez, 37100, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nisa KILIÇ KOÇAK, physiotherapist

CONTACT

[email protected]

+905455932547

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mirror Therapy

Other

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

Other names: Mirror Box Therapy, MT, Mirror Feedback Therapy

Modified Constraint-Induced Movement Therapy

Other

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

Other names: mCIMT

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BİRCAN YÜCEKAYA, Asst.Prof.Dr

CONTACT

[email protected]

+905056226099

NİSA KILIÇ KOÇAK, Msc Student

CONTACT

[email protected]

+905455932547

Sponsors and collaborators

Lead sponsor

Nisa Kiliç Koçak

Other

Collaborators

  • Ondokuz Mayıs University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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