Идёт набор NCT07378774

Constraint Induced Movement Therapy and Bilateral Training in Chronic Stroke

Без фазы С лечением Chronic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: CIMT, bilateral training.
Кому может быть актуально: Состояния в реестре: Chronic Stroke. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Пакистан
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Constraint-Induced Movement Therapy and Bilateral Training in Chronic Stroke

Обзор

Stroke is a leading cause of long-term disability, with upper limb spasticity and impaired hand function being common problems in the chronic phase. These impairments significantly affect independence in activities of daily living and overall quality of life. Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT) are two widely used neurorehabilitation approaches aimed at improving upper limb motor recovery after stroke; however, evidence comparing their effectiveness on wrist spasticity and hand function in chronic stroke patients remains limited. This single-blinded randomized controlled trial aims to compare the effects of Constraint-Induced Movement Therapy combined with Functional Electrical Stimulation (FES) versus Bilateral Training combined with Functional Electrical Stimulation on wrist spasticity and hand function in patients with chronic stroke. A total of 94 participants diagnosed with chronic stroke will be randomly allocated into two groups. Group A will receive CIMT with FES, while Group B will receive Bilateral Training with FES. Both interventions will be administered three times per week for eight weeks. Outcome measures will include wrist spasticity assessed using the Modified Ashworth Scale (MAS) and upper limb motor function assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Chedoke Arm and Hand Activity Inventory (CAHAI). Assessments will be conducted at baseline and after completion of the intervention period. The findings of this study are expected to provide evidence on the comparative effectiveness of CIMT and Bilateral Training in improving wrist spasticity and hand function, thereby assisting clinicians in selecting optimal rehabilitation strategies for chronic stroke patients.

Подробное описание

This study is designed as a single-blinded randomized controlled trial to evaluate and compare the therapeutic effects of Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT), both combined with Functional Electrical Stimulation (FES), on wrist spasticity and hand function in individuals with chronic stroke. Upper limb motor impairment and spasticity are major contributors to functional disability in stroke survivors, particularly in the chronic stage where spontaneous recovery is minimal and structured rehabilitation becomes essential.

Eligible participants with chronic stroke will be recruited from tertiary care hospitals and rehabilitation centers. After obtaining informed consent, participants will be randomly assigned to one of two intervention groups using a computer-generated randomization method. Outcome assessors will remain blinded to group allocation to minimize assessment bias.

Group A will receive CIMT combined with FES. CIMT will involve restraining the non-affected upper limb to encourage intensive use of the affected limb during functional and task-specific activities. Functional Electrical Stimulation will be applied to the wrist extensor muscles to facilitate muscle activation, improve motor control, and reduce spasticity.

Group B will receive Bilateral Training combined with FES. Bilateral Training will emphasize simultaneous use of both upper limbs through symmetrical and functional task-oriented activities to enhance interhemispheric coordination and promote neuroplasticity. FES parameters will remain consistent across both groups to ensure intervention standardization.

Both groups will receive therapy sessions three times per week for eight weeks, following the FITT principle. Outcome measures will be recorded at baseline and after completion of the intervention protocol. Wrist spasticity will be assessed using the Modified Ashworth Scale, while upper limb motor recovery and hand function will be evaluated using the Fugl-Meyer Assessment for Upper Extremity and the Chedoke Arm and Hand Activity Inventory.

This study aims to generate clinically relevant evidence to determine which rehabilitation approach offers superior outcomes in reducing spasticity and improving hand function in chronic stroke patients.

Вмешательства

Поведенческое CIMT
Constraint-Induced Movement Therapy (CIMT) will be administered by restraining the non-affected upper limb using a mitt or glove to promote active use of the affected limb. Participants will perform task-oriented and functional activities such as grasping, releasing, reaching, object manipulation, and activities of daily living using the affected upper limb. Training intensity will be progressively increased based on patient performance. Functional Electrical Stimulation (FES) will be applied to
Поведенческое bilateral training
Bilateral Training will involve simultaneous use of both upper limbs to perform symmetrical and functional task-based activities designed to improve coordination and motor control of the affected upper limb. Exercises will progress from simple bilateral movements to complex functional tasks such as lifting objects, folding towels, and opening containers. Functional Electrical Stimulation (FES) will be applied to the wrist extensor muscles using the same stimulation parameters as the experimental

Первичные конечные точки

Change in Wrist Spasticity [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

Patients diagnosed with stroke in chronic phase. Patients with normal cognition (MMS 21 and above) Both male and female patients will be included. Adult patients will be included. (age 18-65) Participants with spasticity score of 2 or less on MAS.