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临床试验/NCT03396289
NCT03396289已完成不适用

The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy

Bezmialem Vakif University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年2月23日最近更新:
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
30
试验地点
2
主要终点
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Cerebral palsy diagnosis
  • Children with level I or II according to Gross Motor Classification System

排除标准

  • 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

研究组 & 干预措施

Control Group

Active Comparator

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.

干预措施: Conventional physiotherapy including balance exercises (Other)

Training Group

Experimental

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.

干预措施: Conventional physiotherapy including balance exercises (Other)

Training Group

Experimental

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.

干预措施: Inspiratory muscle training (Other)

结局指标

主要结局

Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks

时间窗: Eight weeks

Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

时间窗: Eight weeks

Change from baseline maximum inspiratory pressure at 8 weeks

时间窗: Eight weeks

Change from baseline maximum expiratory pressure at 8 weeks

时间窗: Eight weeks

Change from baseline distance covered in six-minute walk test at 8 weeks

时间窗: Eight weeks

Change from baseline Forced Vital Capacity (FVC) at 8 weeks

时间窗: Eight weeks

Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks

时间窗: Eight weeks

Change from baseline Peak Expiratory Flow (PEF) at 8 weeks

时间窗: Eight weeks

Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks

时间窗: Eight weeks

次要结局

未报告次要终点

研究者

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

Büşra Kepenek Varol

Lecturer, PT, MSc

Bezmialem Vakif University

研究点 (2)

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