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Идёт набор NCT06820398

Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy

Без фазы С лечением 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: Functional exercise with progressive strength and resistance load, Functional exercises without any load.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy. Базовые параметры: 10 лет — 18 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
Испания
Следующий шаг
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Официальное название

Effects of Functional Exercise Program With Strength Load and Resistance in Gross Motor Function, Quality of Life and Participation in Children and Adolescents With Cerebral Palsy Levels III-IV GMFCS

Обзор

This research project aims to evaluate the benefits of a functional exercise program with strength and resistance load in adolescents with cerebral palsy (CP), specifically classifiedat levels III and IV of the Gross Motor Function Classification System (GMFCS) scale. Participants will be included into control or intervention group in this randomized controlled trial. Changes in functional percentile, quality of life, and participation in daily environments will be analyzed based on scores obtained with validated assesment scales. The study will be conducted at the Children's Neurorehabilitation Unit of Hospitalarias Foundation in Valencia, with an 18-week intervention plus a 6-month follow-up. This project seeks to provide evidence on rehabilitation strategies that promote autonomy and social inclusion for this population.

Подробное описание

This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load.

The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments.

The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.

Вмешательства

  • Другое Functional exercise with progressive strength and resistance load
    This group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate.
  • Другое Functional exercises without any load
    This group will perform functional exercises, without strength or resistance load

Первичные конечные точки

  • Functional Percentile Based on Gross Motor Function Classification System (GMFCS) [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).]
Вторичные конечные точки (3)
  • Quality of Life Assessed with CP-QOL Questionnaire [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).]
  • Participation in Daily Environments Assessed with PEM-CY [Срок оценки: Baseline(pre-intervention) and immediately post-intervention (at 18 weeks).]
  • Baseline Heart Rate [Срок оценки: Baseline (pre-intervention) and immediately post-intervention (at 18 weeks).]

Критерии участия

Критерии включения

  • Adolescents aged 10 to 18 years.
  • Diagnosis of spastic cerebral palsy (CP).
  • Classification at levels III or IV of the GMFCS scale.

Критерии исключения

  • Multilevel surgery with osteotomy within the last 12 months.
  • Microtenotomies or percutaneous needle lengthening (APAI) within the last 9months.
  • Botulinum toxin injections within the last 3 months.
  • Participation in specific strength training protocols.
  • Lack of cognitive ability to perform the intervention protocol activities.

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

Испания · 1 центр
  • Faculty of Physiotherapy. University of Valencia — Valencia

Идентификаторы

NCT: NCT06820398 · 3498583

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗