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Набор скоро начнётся NCT07575659

Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy

Без фазы С лечением Cerebral Palsy Cerebral Palsy Early Intervention

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: Perception-Action Approach, Neurodevelopmental Therapy (Bobath).
Кому может быть актуально
Состояния в реестре: Cerebral Palsy, Cerebral Palsy Early Intervention. Базовые параметры: 6 мес. — 36 мес. · 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 the Perception-Action Approach Versus Neurodevelopmental Therapy in Early Intervention for Children With Cerebral Palsy: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare two different physiotherapy approaches used in early intervention for children with cerebral palsy. These approaches are the Perception-Action Approach and Neurodevelopmental Therapy (Bobath). The study aims to understand which approach is more effective in supporting neurodevelopmental outcomes in early childhood in Cerebral Palsy. The main questions this study aims to answer are: How does the Perception-Action Approach affect motor function in young children with cerebral palsy? How does Neurodevelopmental Therapy (Bobath) affect motor function in young children with cerebral palsy? Are there differences in outcomes between these two approaches? Researchers will compare these two approaches to see which one better supports motor development. Participants will: Be children aged 0 to 36 months with cerebral palsy or at high risk Be assigned to one of the two therapy groups Receive one therapy session per week for 12 weeks Be assessed before and after the intervention using standardized tests The results of this study may help therapists and families choose the most effective early intervention approach for children with cerebral palsy.

Вмешательства

  • Поведенческое Perception-Action Approach
    A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
  • Поведенческое Neurodevelopmental Therapy (Bobath)
    A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.

Первичные конечные точки

  • Gross Motor Function Measure-66 (GMFM-66) [Срок оценки: Baseline (pre-intervention) and after 12 weeks of intervention]
Вторичные конечные точки (3)
  • Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) [Срок оценки: Baseline (pre-intervention) and after 12 weeks of intervention]
  • Infant Motor Profile (IMP) [Срок оценки: Baseline (pre-intervention) and after 12 weeks of intervention]
  • Pediatric Evaluation of Disability Inventory (PEDI) [Срок оценки: Baseline (pre-intervention) and after 12 weeks of intervention]

Критерии участия

Критерии включения

  • Diagnosis of Cerebral Palsy
  • Being at high risk for Cerebral Palsy (based on MRI or cranial ultrasound findings and neurological examination)
  • Age between 0-36 months (using corrected age for preterm infants)
  • Parental agreement to participate in the study and attend all assessment and therapy sessions; signed informed consent form from the parent(s) or legal guardian(s)

Критерии исключения

  • Presence of severe visual or hearing impairment that would prevent full participation in therapy sessions
  • Uncontrolled seizures
  • Receipt of botulinum toxin injection or orthopedic surgery within the last 6 months
  • Diagnosis of an additional neurometabolic, genetic, or other neurological disorder

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

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Pick, H. L. (1994). Eleanor J. Gibson: Learning to perceive and perceiving to learn. In A century of developmental psychology (pp. 527-544). American Psychological Association. https://doi.org/10.1037/10155-018
  • Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. A comparison of interventions for children with cerebral palsy to improve sitting postural control: a clinical trial. Phys Ther. 2010 Dec;90(12):1881-98. doi: 10.2522/ptj.2010132. Epub 2010 Oct 21. PMID 20966212
  • Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7. PMID 27925172
  • Damiano DL, Longo E. Early intervention evidence for infants with or at risk for cerebral palsy: an overview of systematic reviews. Dev Med Child Neurol. 2021 Jul;63(7):771-784. doi: 10.1111/dmcn.14855. Epub 2021 Apr 6. PMID 33825199
  • Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol. 2001 Nov;43(11):778-90. doi: 10.1017/s0012162201001414. No abstract available. PMID 11730153

Идентификаторы

NCT: NCT07575659 · 2026/55

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗