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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* 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.
排除标准
- •* 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.
研究者
Nisa Kiliç Koçak
Master's Student Nisa Kılıç KOÇAK
Ondokuz Mayıs University