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临床试验/NCT05636241
NCT05636241已完成不适用

The Effect of Whole Body Vibration on Walking Parameters in Children With Cerebral Palsy

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
13
试验地点
2
主要终点
Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

研究概览

简要总结

Some positive effects of whole body vibration applications in reducing spasticity, improving walking ability, and increasing walking speed have been reported in children with CP, but the evidence is not strong enough. Therefore, this study was planned to evaluate the effect of whole body vibration treatment on spasticity, gait, balance, and motor performance in children with spastic CP. This study hypothesis that whole body vibration provides an additive improvement on spasticity, balance, gait and motor performance.

详细描述

Participants will be evaluate at baseline, after the conventional physiotherapy program, and after whole body vibration training program. During this period, the participants who were recruited whole body vibration training program, whole body vibration will be applied in addition to conventional physiotherapy sessions comprised 45 min, 2 days a week, during 8 week.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children diagnosed with spastic diplegic CP in GMFCS levels I and II, CFCS level I and MACS levels I and II
  • Aged 6-17 years
  • Ability to cooperate with the evaluations
  • Walking independently with or without an orthosis (without any support)

排除标准

  • Having a recent injury affecting the lower extremities
  • Having undergone any surgery or Botulinuim Toxin application within the last six months
  • Having severe cardiopulmonary or systemic problems
  • Having uncontrolled seizures, visual or hearing problems preventing the evaluations

结局指标

主要结局

Spatiotemporal parameters of gait will be evaluated with the Zebris™ FDM-2 gait analysis platform.

时间窗: Change from baseline velocity at 2 months.

Gait analysis will be performed without any shoes and assistive devices. Walking evaluation on the gait platform will be limited to 1 minute. Obtained data about velocity will be collected as meters/seconds from the entire 1-minute walk will use for analysis.

次要结局

  • The Pediatric Balance Scale will be used to measure functional balance of the participants.(Change from baseline score at 2 months.)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Ozge OKUR

Assistant Professor

Kutahya Health Sciences University

研究点 (2)

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