Robotic Glove Training on Hand Function in Unilateral 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: Conventional Physical Therapy Program, Robotic Glove Training.
- Кому может быть актуально
- Состояния в реестре: Unilateral Spastic Cerebral Palsy. Базовые параметры: 5 лет — 12 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
- Список центров уточняется — проверьте первичный протокол.
- 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
Efficacy of Task-Oriented Robotic Glove Training on Hand Function in Children With Unilateral Spastic Cerebral Palsy. A Randomized Controlled Trial
Обзор
The purpose of the study is to investigate the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Подробное описание
Children with unilateral spastic cerebral palsy commonly experience impaired hand function, muscle weakness, and reduced fine motor control, which limit their ability to perform daily functional activities and decrease independence. Recent advances in rehabilitation technology, such as soft robotic gloves provide assisted and repetitive hand movements to facilitate motor learning that in turm improve hand function, and bimanual activities required for everyday life. Several studies support the benefit of soft robotic gloves on hand function among adults with neurological disorders while, there is limited evidence conducted its effect on children with unilateral cerebral palsy. Hence, there is need to study the the effect of task-oriented robotic glove training on hand function in children with unilateral spastic cerebral palsy.
Fourty children with unilateral spastic cerebral palsy (based on power analysis) from both sexes (5-12 years) will be recruited from outpatient clinics at faculty of physical theray, Deraya and Beni-Suef University, and different pediatric physical therapy rehabilitation clinics. They will be divided randomly into control group (20 children) and study group (20 children). Control group will be participated in conventional physical therapy program. Study group will be received task-oriented training with soft robotic glove in addition to the same conventional physical therapy in control group
Вмешательства
- Другое Conventional Physical Therapy Program
The conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training. - Другое Robotic Glove Training
The conventional physical therapy program include neurodevelopmental facilitation technique, proprioceptive training, facilitation of righting, equilibirum and protective reaction, passive stretching for tight muscles, active-assisted and active-free exercises for weak muscles, and hand skills training. Also, task-oriented training in the form of grasping and releasing balls into a barrel, placing and removing pegs, and passing rings along rode with soft robotic glove.
Первичные конечные точки
- Grip Strength [Срок оценки: Up to 12 weeks]
- Pinch Strength [Срок оценки: Up to 12 weeks]
- Finger Range of Motion [Срок оценки: Up to 12 weeks]
Вторичные конечные точки (1)
- Fine and Gross Motor Hand Function [Срок оценки: Up to 12 weeks]
Критерии участия
Критерии включения
- Children ages will be ranged from 5 to 12 years.
- Children with mild to moderate spasticity of the wrist flexor muscles, graded 1,+1 and 2 according to the Modified Ashworth Scale.
- Ability to grasp and release objects with affected hand (Level I or II or III in accordance with the Manual Ability Classification System (MACS)).
- Sufficient cognition to follow simple verbal instructions.
Критерии исключения
- Fractures, fixed deformities, or severe contractures in the upper limb.
- Visual or auditory defects.
- Previous surgical intervention or Botulinum toxin injection in the last 6 months.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07482631 · FPTBSUREC/0311/15326