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临床试验/NCT01831414
NCT01831414已完成不适用

Etude Pilote évaluant l'Effet du Niveau d'Immersion Sur la Fonction Respiratoire Des Patients tétraplégiques bénéficiant de balnéothérapie

Centre d'Investigation Clinique et Technologique 8052 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Lung volumes

研究概览

简要总结

Balneotherapy is a physiotherapy technique which allows patients to work out in a weightless environment and which is often used in patients with spinal cord injury. In normal subjects, water immersion generates a reduction in lung volumes. The effects of water immersion on the respiratory function of spinal cord injury patient (who are liable to present a respiratory failure secondary to paralysis) are not well known. They could be deleterious (by majoring respiratory failure)or beneficial (by mimicking the effect of a corset and improving respiratory function). Therefore, we are planning to study the effect of different water immersion levels on the respiratory function of spinal cord injury patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
盲法
None

入排标准

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

入选标准

  • Adult Patient
  • complete tetraplegia from spinal cord injury
  • initial spinal cord injury at leat 3 months before study

排除标准

  • contra indication to a balneotherapy session (bed-sore, skin infection or irritation, urinary or fecal incontinency, tracheostomy, ongoing infection)
  • unstable respiratory state (patient free of respiratory infection or encumbrance)
  • refusal to participate to the protocol
  • pregnancy

结局指标

主要结局

Lung volumes

时间窗: 1 hour

Measurement of lung volumes (Vital capacity, Forced Expiratory volume at 1 second and total lung capacity) measured by standard pulmonary function test

次要结局

  • Respiratory comfort(1 hour)

研究者

发起方
Centre d'Investigation Clinique et Technologique 805
申办方类型
Other
责任方
Sponsor

研究点 (2)

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