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Набор скоро начнётся NCT07249866

Effect of Robotic Assisted Therapy on Hand Functions, Grip Strength and Proprioception in Children With Hemiplegia

Без фазы С лечением Cerebral Palsy, Spastic

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: Hand rehabilitation robotic gloves, occupational therapy.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy, Spastic. Базовые параметры: 6 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
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Statement of the problem: Does robotic assisted therapy have an effect on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy? Significance of the study: New technologies allow and promote active involvement, leading directly to functional changes that are far beyond those obtained with conventional therapy. Many features of robotic therapy may contribute to enhanced recovery of upper limb motor function. These include task-specific practice, intensity of repetition, robotic assistance, enhanced sensory feedback, continual motivation (because every trial yields a degree of success, even if robot assistance is required). The implementation of robotics with hemiplegic cerebral palsy focuses on functional motor performance by providing intensive repetitive training, sensorimotor integration and cognitive engagement through goal-directed tasks to address the underlying symptoms. Robotic technologies offer numerous potential advantages over conventional therapies, chief among these being the ability to provide high-intensity repetitive training. Robotic treatment is a novel approach that has demonstrated promise in enhancing motor function, enhancing the quality of life, and lessening the burden on caregivers.

Подробное описание

Thirty two children with hemiplegic cerebral palsy from both sexes according to G\*power analysis (α= 0.05 , Power= 0.90 , effect size = 0.89) Their ages range from 6- 9 years. Mild to moderate degree of spasticity, according to modified Ashworth scale (grade 1 to 2).

Motor function level will be I and II according to gross motor function classification system.

Assessment will be conducted using Bruininks Oseretsky test of motor proficiency scale 2nd edition (BOT-2) for assessment of fine motor control , handheld dynamometer will be used for measuring hand grip strength and digital goniometer for measuring wrist joint sense of position.

Children in the study group will receive robotic assisted therapy.

Null Hypothesis:

There will be no effect of robotic assisted therapy on hand functions, grip strength and proprioception in children with hemiplegic cerebral palsy .

Basic assumptions:

All children will attend the treatment program regularly. All children will follow the same sequence of the treatment procedure. All children will be cooperative and following the instructions during evaluation and treatment procedures.

The results of the study will be helpful for physical therapists dealing with children with the same condition

Inclusion Criteria:

Their ages range from 6-9 years. They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS Their manual abilities will be at level II and Level III according to Manual Ability classification system as mentioned in a previous review They will be able to understand and follow instructions

Exclusion criteria:

Fixed deformity in any joints of the upper limb. Previous history of surgical intervention in the upper limb. Auditory, visual and cognitive problems. Botulinum Toxin injection in last 6 months

Вмешательства

  • Устройство Hand rehabilitation robotic gloves
    robotic gloves assist in hand functions
  • Другое occupational therapy
    designed traditional occupational therapy program

Первичные конечные точки

  • hand grip strength by hand held dynamometer [Срок оценки: 8 weeks]
  • hand functions ( fine motor precision and integration measured by Bruininks-Oseretsky Test of Motor Proficiency [Срок оценки: 8 weeks]
  • wrist joint proprioception by digital goniometer [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Their ages range from 6-9 years
  • They have mild to moderate spasticity (grade 1- 2) according to Modified Ashworth Scale
  • Their motor function will be at level I and II according to Gross Motor Function Classification System GMFCS
  • Their manual abilities will be at level II and Level III according to Manual Ability classification system
  • They will be able to understand and follow instructions

Критерии исключения

  • Fixed deformity in any joints of the upper limb.
  • Previous history of surgical intervention in the upper limb.
  • Auditory, visual and cognitive problems.
  • Botulinum Toxin injection in 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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Cairo University — Cairo

Идентификаторы

NCT: NCT07249866 · P.T.REC/012/005785

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗