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临床试验/NCT04134533
NCT04134533已完成不适用

Motor Functional Level and Quality of Life According to Feeding Types in Children With Cerebral Palsy

Hacettepe University1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
Gross motor Function Measurement

研究概览

简要总结

The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy.

详细描述

The aim of this study is to compare motor functions and quality of life of the children, and anxiety and depression levels of caregivers according to feeding type of children with cerebral palsy. Children will be divided into two groups: children with oral feeding and children with non-oral feeding, according to Functional Oral Intake Scale. Gross Motor Function Classification System will be used for classify children according to gross motor function, Gross Motor Function Measurement will be used for evaluate gross motor functions, and parent-reported Pediatric Quality of Life Inventory will be used for evaluate quality of life of children. To measure caregivers' anxiety and depression levels will be assessed by using Beck Depression Inventory and Beck Anxiety Inventory. Parametric or non-parametric tests will be applied according to the variables distribution. Through this analyses, determination of the difference between feeding type groups and other categorical and continuous variables will be decided.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children who were diagnosed with CP
  • Aged between 5-18 years
  • Must have cooperation
  • Feed by orally or non-orally

排除标准

  • Having other accompanying neurodegenerative diseases.
  • Acute respiratory tract infection
  • Complications of enteral feeding

结局指标

主要结局

Gross motor Function Measurement

时间窗: 2 months

The Gross Motor Function Measurement (GMFM) is an observational clinical tool to evaluate motor function of children with CP. It has five basic sections that evaluate motor function in detail, including lying and rolling; sitting; crawling and kneeling; standing; and walking, running, and jumping, with a total of 88 items. Each evaluation is scored according to the level of achieving gross motor function without considering the quality of movement. While children performing each task in the GMFM, a physiotherapist scored each evaluation on a Likert scale between 0 to 3, of which 0 means 'Does not initiate' and 3 means 'Completes'.

次要结局

  • Gross Motor Function Classification System(2 months)
  • Pediatric Quality of Life Inventory(2 months)
  • The Turkish version of the Beck Depression Inventory and Beck Anxiety Inventory(2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre CENGIZ

Research Assistant

Hacettepe University

研究点 (1)

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