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| Name | Class |
|---|---|
| Ondokuz Mayıs University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirror Therapy | Other | Mirror therapy protocols targeting upper extremity motor functions for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Independence Measure (FIM) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Other Pre-Specified | 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) |
Inclusion Criteria:
* Diagnosis: Confirmed first ischemic or hemorrhagic stroke with clinical and neurological evaluation.
Exclusion Criteria:
* Uncontrolled diabetes or other metabolic disorders.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| NİSA KILIÇ KOÇAK, Msc Student | Contact | +905455932547 | nisakilicas12@gmail.com | |
| BİRCAN YÜCEKAYA, Asst.Prof.Dr | Contact | +905056226099 | bircan.yucekaya@omu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| BİRCAN YÜCEKAYA | Ondokuz Mayıs University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akay Special Education and Rehabilitation Center | Recruiting | Kastamonu | Merkez | 37100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38873866 | Result | 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. |
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To protect participant confidentiality in accordance with institutional review board regulations and informed consent limitations.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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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.
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| Modified Constraint-Induced Movement Therapy | Other | Modified constraint-induced movement therapy (modified CIMT) protocols targeting the affected upper extremity for 4 weeks. |
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| Baseline (pre-treatment) and 4 weeks (post-treatment) |
| Motor Activity Log-28 (MAL-28) | 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) | 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) |
| Modified Rankin Scale (mRS) | 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) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |