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临床试验/CTRI/2025/11/096908
CTRI/2025/11/096908尚未招募不适用

Effect of Nursing Interventions on Feeding Difficulties of Children with Cerebral Palsy: A Randomized Controlled Trial

KLE Academy of Higher Education and Research KAHER1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
124
试验地点
1
主要终点
Intervention group will show significant reduction in the feeding difficulties

研究概览

简要总结

This study is a randomised controlled trial to see the impact of Nursing interventions on feeding difficulties in children with cerebral palsy. The sample size is 124 children with cerebral palsy who have feeding difficulties. Nursing intervention will be administered to the experimental group for over 6 sessions over the period of 3 months. The primary outcome  improvement in feeding difficulties and secondary outcome Body mass index is assessed after 3 months.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
3.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children with cerebral palsy Aged 3-12 years Children with cerebral palsy Classified as Gross Motor Function Classification System Levels 2-4 Children with cerebral palsy having feeding difficulties.

排除标准

  • Children with cerebral palsy classified as GMFCS Level V Children with cerebral palsy who have frequent or uncontrolled seizures Children with profound hearing loss not corrected with aids or cochlear implants leading to major communication barriers during feeding therapy Children with cerebral palsy who are intellectually disable who have autism ADHD Other comorbid conditions affecting feeding Cleft palate GI anomalies Mothers or the primary caregivers with a history of diagnosed psychiatric illness like schizophrenia major depression or who are currently under psychiatric treatmen Mothers or the primary caregivers with speech or hearing disabilities that make communication difficult during the sessions.
  • Mothers or the primary caregivers who are not living with the child full-time or are not involved in feeding the child Mothers or the primary caregivers who are currently enrolled in another clinical trial or similar intervention program.

结局指标

主要结局

Intervention group will show significant reduction in the feeding difficulties

时间窗: 1 week and 12 weeks

次要结局

  • Intervention group will show significant increase in BMI after administering the nursing interventions(1st month and 3rd month)

研究者

发起方
KLE Academy of Higher Education and Research KAHER
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Priyanka Gudannawar

KAHER, Belagavi

研究点 (1)

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