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临床试验/NCT03484078
NCT03484078进行中(未招募)不适用

Effect of Vibration on Muscle Properties, Physical Activity and Balance in Children with Cerebral Palsy

University of Georgia2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年1月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
44
试验地点
2
主要终点
Change in fat concentration

研究概览

简要总结

The aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.

详细描述

Cerebral palsy (CP) is a movement disorder that affects over 800,000 people in the U.S. Due to the limited mobility associated with the disorder, individuals with CP have an increased risk of chronic diseases, such as cardiovascular disease, diabetes mellitus and osteoporosis, compared to the general population. Therefore, identifying treatment strategies is of utmost importance. The aim of this study is to examine the acute and chronic effects of low-magnitude vibration on muscle, physical activity, and balance in children with CP. Fat concentration and muscle will be assessed using imaging techniques. Physical activity will be assessed using activity monitors. Balance will be assessed using clinical and biomechanical tests. Children with CP will be tested at five time points: baseline, 1 and 6 months after standing on a vibration platform daily 10 minutes per day, 1 and 6 months post treatment (7 months and 12 months from baseline, respectively). The findings from the proposed study will help us determine if vibration shows promise as a treatment for the impaired mobility, lower physical activity and higher risk of chronic disease in individuals with CP.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Spastic cerebral palsy
  • Independent ambulator without an assistive device (Gross Motor Function Classification System level I or II)

排除标准

  • Prior fractures in both femurs or tibias
  • Currently taking bisphosphonates
  • Unable to stand independently
  • Orthopedic surgery on a lower extremity within the last 6 months
  • Children with pure athetoid CP
  • Baclofen pump in the abdomen
  • Botox treatment within the last year

结局指标

主要结局

Change in fat concentration

时间窗: Baseline, 6 months and 12 months

Change in fat concentration assessed using imaging techniques

次要结局

  • Change in physical activity(Baseline, 1 month, 6 months, 7 months, and 12 months)
  • Change in muscle size(Baseline, 6 months and 12 months)
  • Change in static balance(Baseline, 1 month, 6 months, 7 months, and 12 months)
  • Change in dynamic balance(Baseline, 1 month, 6 months, 7 months, and 12 months)

研究者

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

Christopher Modlesky

Professor

University of Georgia

研究点 (2)

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