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临床试验/NCT03616080
NCT03616080已完成不适用

Effect of Soccer Play in Children With Cerebral Palsy

The Catholic University of Korea2 个研究点 分布在 2 个国家目标入组 19 人开始时间: 2017年12月18日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Change of FVC after soccer program
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
  2. To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
  3. Safety of soccer play in children with cerebral palsy

详细描述

  1. 1 hr of play once a week for 8 weeks of soccer program was done in the experimental group.
  2. Both the experimental and control group were children with ambulatory cerebral palsy aged 5 to 12 years.
  3. Several outcomes were measured before and after the program
  • pulmonary function test including FVC, FEV1
  • GMFM-88, PBS, walking test, muscle power sprint test, timed up and go, gait parameters
  • Child Health Questionnaire Parent Form 50 (CHQ-PF50)
  • KIDSCREEN
  1. An accelerometer was worn before the program and during the program for a week (experimental group only)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
5 Years 至 12 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •children with cerebral palsy
  • •GMFCS level I-II
  • •5-12 years old

排除标准

  • •acute disease, less than 6 months from the surgery
  • •the behavioral or psychiatric problem that hinders group activity
  • •intellectual disability to do the questionnaire
  • •who do not participate in the class well (absent more than 3 times)

结局指标

主要结局

Change of FVC after soccer program

时间窗: before and after the program, up to 10 weeks interval

FVC, forced vital capacity (L)

次要结局

  • Change of physical activity with soccer program(before and during the program (about 3-4 weeks interval))
  • Change of QOL (parents)(before and after the program, up to 10 weeks interval)
  • Change of anaerobic test after soccer program(before and after the program, up to 10 weeks interval)
  • Change of QOL (children)(before and after the program, up to 10 weeks interval)
  • Change of FEV1 after soccer program(before and after the program, up to 10 weeks interval)
  • Change of gross motor function after soccer program(before and after the program, up to 10 weeks interval)
  • Change of balance after soccer program1(before and after the program, up to 10 weeks interval)
  • Change of balance after soccer program2(before and after the program, up to 10 weeks interval)

研究者

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

Bo Young Hong

Associate professor

The Catholic University of Korea

研究点 (2)

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