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Идёт набор NCT07747974

Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy in Spastic Hemiplegic Cerebral Palsy Children

Без фазы С лечением Spastic Hemiplegic Cerebral Palsy

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: Experimental, Control.
Кому может быть актуально
Состояния в реестре: Spastic Hemiplegic Cerebral Palsy. Базовые параметры: 5 лет — 9 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
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Официальное название

A Randomized Controlled Trial to Compare the Effectiveness of Modified Constraint-Induced Movement Therapy Versus Mirror Therapy on Grip Strength, Manual Dexterity, and Spasticity in Children With Spastic Hemiplegic Cerebral Palsy

Обзор

This randomized controlled trial was conducted to compare the effectiveness of Modified Constraint-Induced Movement Therapy (MCIMT) and Mirror Therapy in improving upper limb function among children with spastic hemiplegic cerebral palsy. Upper limb dysfunction, including reduced grip strength, impaired manual dexterity, and increased spasticity, limits functional independence and participation in daily activities in these children. Although both interventions are widely used in pediatric rehabilitation, direct comparative evidence remains limited. A total of 42 children aged 5-9 years diagnosed with spastic hemiplegic cerebral palsy were recruited from Akbar Kare Institute and Comprehensive Physical Rehabilitation Center, Peshawar. Participants were selected through convenience sampling and randomly allocated into two equal groups using the sealed envelope method. Group A received Modified Constraint-Induced Movement Therapy, while Group B received Mirror Therapy. Both groups received treatment for 30 minutes per session, five sessions per week, for six consecutive weeks. Grip strength was assessed using the Hand-Held Dynamometer, manual dexterity using the Box and Block Test, and spasticity using the Modified Ashworth Scale. The findings of this study provide evidence regarding the comparative effectiveness of these two rehabilitation approaches and may assist clinicians in selecting the most appropriate intervention for improving upper limb function in children with spastic hemiplegic cerebral palsy.

Подробное описание

This study employed a parallel-group randomized controlled trial design to evaluate the comparative effectiveness of Modified Constraint-Induced Movement Therapy and Mirror Therapy. Following ethical approval, eligible participants were recruited according to predefined inclusion and exclusion criteria. After obtaining informed consent from parents or guardians, baseline assessments were performed.

Participants were randomly assigned to one of two intervention groups. Both groups received standardized treatment sessions lasting 30 minutes, five days per week for six weeks. Outcome measures included grip strength measured with a Hand-Held Dynamometer, manual dexterity measured using the Box and Block Test, and spasticity measured using the Modified Ashworth Scale. Assessments were conducted before and after completion of the intervention period. Statistical analysis was performed using SPSS Version 26 with a significance level of p \< 0.05.

Вмешательства

  • Другое Experimental
    Participants received MCIMT for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy.
  • Другое Control
    Participants received Mirror Therapy for 30 minutes per session, five sessions per week for six weeks, together with conventional physiotherapy.

Первичные конечные точки

  • Grip Strength [Срок оценки: Assessment Time: Baseline and 6 Weeks]
Вторичные конечные точки (2)
  • Manual Dexterity [Срок оценки: Assessment Time: Baseline and 6 Weeks]
  • Spasticity [Срок оценки: Assessment Time: Baseline and 6 Weeks]

Критерии участия

Критерии включения

  • Children aged 5-9 years.
  • Male and female participants.
  • Diagnosed with spastic hemiplegic cerebral palsy.
  • Modified Ashworth Scale Grade 1 or 1+.
  • Able to understand and follow verbal commands.

Критерии исключения

  • Severe fixed hand deformity.
  • Cognitive impairment.
  • Severe visual impairment.
  • Uncontrolled seizures.
  • Previous upper limb surgery.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Ibadat International University — Islamabad

Идентификаторы

NCT: NCT07747974 · IIUI/RERC/ADT/2026/02/258

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗