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临床试验/NCT01872507
NCT01872507已完成不适用

The Effect of Breathing Biofeedback Training to Influence the Function of the Cardiac Autonomic Nervous System at Rest and in Activity in Children With Cerebral Palsy.

Hadassah Medical Organization2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change from Baseline of Heart rate variability meaures at one and two months

研究概览

简要总结

The effect of breathing biofeedback training to influence the function of the cardiac autonomic nervous system at rest and in activity in children with cerebral palsy.

Cerebral palsy children suffer from a non-progressive damage of the brain. It is the most common injury that causes physical handicapped in childhood. There are a few researches that investigated the autonomic function in cerebral palsy children. Those researches found hyperactivity of the sympathetic autonomic system, including high resting heart rate compare to their typically developed pears. The recommended treatment for cerebral palsy is activity, muscle strengthening and mobility. The impairment in the autonomic system influences the everyday function and has correlation with secondary morbidity.

As far as we know there are no researches who investigated the following issues.

In this study we would like to:

  1. Describe the autonomic cardiac function, Breathing function, motor function and the correlation between them in children with cerebral palsy.
  2. Compare the autonomic cardiac function at rest in aerobic test and in diaphragmatic breathing.
  3. Test the influence of breathing training on Heart rate variability parameters at rest, in aerobic test right after the breathing training program and one month after, in children with cerebral palsy

详细描述

Participants:

60 children with cerebral palsy age 6-11 who can walk and understand simple instructions.

Main outcome measures:

Heart rate variability using Polar watch and transmitter RS810CX.

Secondary outcome measures:

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
None

入排标准

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

入选标准

  • children with cerebral palsy
  • age 6-11 years
  • able to walk
  • both gender

排除标准

  • heart or lung known disease
  • can not follow simple commends

研究组 & 干预措施

biofeedback training

Active Comparator

usual treatment+12 treatment of biofeedback training

干预措施: Biofeedback training (Other)

control

No Intervention

usual treatment

结局指标

主要结局

Change from Baseline of Heart rate variability meaures at one and two months

时间窗: Change from Baseline at one and two months

次要结局

  • Change from Baseline Sub maximal aerobic test on treadmill-Modified Naughton Protocol with Polar watch and transmitter.(Change from baseline at one and two month later)
  • Change from Baseline of Forced Vital Capacity, Forced Expiratory Volume in one, Tidal Volume,(Change from Baseline at one and two month)
  • Change from baseline breathing rate, by biofeedback(Change from baseline at one and two month later)

研究者

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

BERGER ITAI

Director Neuro-Cognitive Center Pediatric Wing

Hadassah Medical Organization

研究点 (2)

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