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Идёт набор NCT07233824

Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy

Без фазы С лечением Hemiplegic Cerebral Palsy Cerebral Palsy (CP) Core Stabilization Exercise

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: Exercise, Exercise.
Кому может быть актуально
Состояния в реестре: Hemiplegic Cerebral Palsy, Cerebral Palsy (CP), Core Stabilization, Exercise. Базовые параметры: 6 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
Turkey (Türkiye)
Следующий шаг
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Официальное название

Effects of Fun-Core (Child-Friendly Core Stabilization) Exercises on Balance and Functional Mobility in Children With Spastic Cerebral Palsy: A Single-Blind Randomized Controlled Trial

Обзор

A total of 54 children, aged between 6 and 12 years, diagnosed with hemiplegic cerebral palsy and not meeting the exclusion criteria, who registered at the outpatient clinics of the Department of Physical Medicine and Rehabilitation, Istanbul University, Istanbul Faculty of Medicine, between June 1, 2025 and March 1, 2026, were planned to be included in our thesis study, which was planned to be prospective, randomized and single-blind. Children and their parents will be informed verbally and in writing about the study's purpose, duration, and method of implementation, and their informed consent will be obtained. They will be asked to sign an "Informed Consent Form." Patient assessment and follow-up forms will be completed at pre- and post-treatment follow-ups. Patients who meet the inclusion criteria will be numbered according to their order of admission and then randomly assigned to either the intervention or control groups by a computer program. In addition to a brochure showing the number of sets and repetitions to be given to the patients as a standard home exercise program, the Fun-Core video exercise program, designed as a child-friendly core stabilization exercise program to be performed 3 times a week, will be given to the intervention group (G1), and the exercises will be delivered to the participants through a website with special accounts. The control group (G2) will receive a standard home exercise program in brochure format, showing the number of sets and repetitions. The exercise program will be performed at home three times a week for 8 weeks.

Вмешательства

  • Другое Exercise
    Fun-Core Exercises will be narrated, prepared and recorded in video format, and then delivered in order to ensure children's development and motivation.
  • Другое Exercise
    Standard home based exercise program

Первичные конечные точки

  • Modified Timed Up & Go Test [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • Pediatric Balance Scale [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
Вторичные конечные точки (6)
  • Six Minute Walk Test [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • Trunk Endurance Tests [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • Pediatric Reach Test [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • WeeFIM [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • PEDQoL 4.0 Pediatric Quality of Life Questionnaire [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]
  • Children/ Youth with Cerebral Palsy Brief (6-13 years of age) [Срок оценки: Day 1 (before starting treatment), Day 60 (end of treatment), Day 90 (one month after the end of treatment)]

Критерии участия

Критерии включения

  • Children with hemiplegic cerebral palsy between the ages of 6 and 12
  • Children with Gross Motor Function Classification System (GMFCS) Levels 1, 2, and 3
  • Shoe sizes 30 and above

Критерии исключения

  • Cognitive impairments that prevent understanding and performing simple commands and tasks
  • Botulinum toxin injections into the upper and/or lower extremities within the last 6 months
  • History of lower extremity or lumbar surgery within the last year
  • Presence of uncontrolled severe epileptic seizures
  • Presence of severe vision or hearing problems
  • Presence of fixed contractures in the lower extremities

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

Turkey (Türkiye) · 1 центр
  • Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Reh — Istanbul

Идентификаторы

NCT: NCT07233824 · E-29624016-050.99-3354321

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗