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Набор по приглашению NCT07644572

Individualized Nutrition Intervention in Children With Cerebral Palsy

Без фазы С лечением Cerebral Palsy Cerebral Palsy (CP)

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: Individualized Nutrition Intervention.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy, Cerebral Palsy (CP). 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

The Effect of Individualized Nutrition Intervention on Nutritional Status, Gastrointestinal Symptoms, and Quality of Life in Children With Cerebral Palsy: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if individualized nutrition support can improve nutrition, gastrointestinal symptoms, and quality of life in children with cerebral palsy. The main questions it aims to answer are: Does individualized nutrition support improve the nutrition status of children with cerebral palsy? Does individualized nutrition support improve gastrointestinal symptoms and quality of life? Researchers will compare children who receive individualized nutrition support with children who receive routine care. Participants will: Be randomly placed into one of two groups Have their nutrition status assessed Have their gastrointestinal symptoms and quality of life assessed Receive individualized nutrition support or continue routine care

Вмешательства

  • Поведенческое Individualized Nutrition Intervention
    Participants in the intervention group will receive individualized nutrition counseling and dietary recommendations based on nutritional status, dietary intake, anthropometric measurements, gastrointestinal symptoms, and individual needs. The intervention will include assessment of dietary intake, individualized dietary planning, nutrition education, and follow-up during the 8-week study period. No drug, device, or dietary supplement will be administered as part of the intervention.

Первичные конечные точки

  • Change in Cerebral Palsy Quality of Life Questionnaire for Children Score [Срок оценки: Baseline and week-8]
Вторичные конечные точки (3)
  • Change in Body Mass Index-for-Age Z-Score [Срок оценки: Baseline and Week 8]
  • Change in Gastrointestinal Symptoms [Срок оценки: Baseline and Week 8]
  • Change in Youth Healthy Eating Index Score [Срок оценки: Baseline and Week 8]

Критерии участия

Критерии включения

  • Children aged 6 to 12 years diagnosed with cerebral palsy
  • Children classified as Gross Motor Function Classification System (GMFCS) levels I to III
  • Children who are orally fed
  • Children whose parent or legal guardian provides written informed consent
  • Children who are able to complete baseline and follow-up assessments

Критерии исключения

  • Exclusion Criteria:
  • Children who had an acute illness or serious infection within 10 days before being invited to the study
  • Children with a genetic syndrome that may affect nutritional status, such as Silver-Russell syndrome or Down syndrome
  • Children who are not orally fed or who receive enteral or parenteral nutrition support
  • Children who participated in any dietary intervention during the last 3 months
  • Children who received or started any new treatment other than routine physical therapy during the last 3 months, such as botulinum toxin injection, orthopedic surgery, or a new intensive rehabilitation program
  • Children whose parent or legal guardian cannot fully understand the study procedures or does not speak Turkish
  • Children who used any food supplement or vitamin supplement during the last 3 months
  • Children who do not comply with the diet during the intervention or who wish to withdraw from the study

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

Turkey (Türkiye) · 1 центр
  • Gazi University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation — Ankara

Идентификаторы

NCT: NCT07644572 · CPGAZIBDB

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗