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临床试验/NCT02406404
NCT02406404已完成不适用

Change of Pulmonary Function After Incentive Spirometer Training in Children With Cerebral Palsy

Yonsei University2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
2
主要终点
Forced vital capacity

研究概览

简要总结

This study was designed to examine the effect of incentive spirometry in pulmonary rehabilitation of children with cerebral palsy. The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. If the patient assigned to training group, the subjects started to respiratory muscle strengthening exercise using incentive spirometry. The training was performed ten sessions daily, for 4 weeks. Respiratory function tests including forced vital capacity, forced expiratory volume in 1 second, Peak cough flow, maximal phonation time were compared before interventions and at the end of exercise.

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
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • male or female, 4 to 18 years
  • patients who are committed to comply with protocol-required procedures
  • GMFCS (Gross motor function classification system) level II, III, IV
  • Stable medical condition in the investigator's opinion
  • Acceptable chest radiologic result who has no evidence of pulmonary disease

排除标准

  • Any uncontrolled clinically significant medical condition other than the one under study
  • Patients with cognitive impairment who are unable to comply with protocol-required procedure
  • Patients with presence or history of tracheostomy
  • Patients who are taking medications that can affect respiratory function

结局指标

主要结局

Forced vital capacity

时间窗: within 3 days after respiratory muscle training

Forced vital capacity means amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Measuring FVC is done through spirometry testing.

次要结局

  • forced expiratory volume in 1 second(within 3 days after respiratory muscle training)
  • Peak cough flow(within 3 days after respiratory muscle training)
  • maximal phonation time(within 3 days after respiratory muscle training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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