The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
2018年6月27日 更新者:Büşra Kepenek Varol、Bezmialem Vakif University
Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period.
Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders.
It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated.
Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children.
Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP.
However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training.
Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance.
Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development.
Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP.
The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Istanbul、火鸡、34093
- Bezmialem Vakif University
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
7年 至 16年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Cerebral palsy diagnosis
- Children with level I or II according to Gross Motor Classification System
Exclusion Criteria:
- Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
- Severe convulsions that can not be controlled by drugs
- Congenital malformation accompanying cerebral palsy
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Control Group
Patients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks.
One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home.
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Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System.
Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
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实验性的:Training Group
In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks.
One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home.
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Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System.
Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
Threshold IMT device will be used for the training.
Training intensity will set at 30% of the maximum inspiratory pressure.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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8 周时用力肺活量 (FVC) 相对于基线的变化
大体时间:八周
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八周
|
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第 8 周时第 1 秒用力呼气量 (FEV1) 相对于基线的变化
大体时间:八周
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八周
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8 周时基线峰值呼气流量 (PEF) 的变化
大体时间:八周
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八周
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8 周时六分钟步行测试覆盖的基线距离的变化
大体时间:八周
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八周
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Change from baseline maximum inspiratory pressure at 8 weeks
大体时间:Eight weeks
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Eight weeks
|
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Change from baseline maximum expiratory pressure at 8 weeks
大体时间:Eight weeks
|
Eight weeks
|
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Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
|
Eight weeks
|
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Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
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Eight weeks
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Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
大体时间:Eight weeks
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Eight weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年2月23日
初级完成 (实际的)
2018年6月25日
研究完成 (实际的)
2018年6月25日
研究注册日期
首次提交
2018年1月5日
首先提交符合 QC 标准的
2018年1月5日
首次发布 (实际的)
2018年1月10日
研究记录更新
最后更新发布 (实际的)
2018年6月28日
上次提交的符合 QC 标准的更新
2018年6月27日
最后验证
2018年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.