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临床试验/NCT03471676
NCT03471676已完成不适用

Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.

University Hospital, Tours1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年3月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Muscular oxygenation

研究概览

简要总结

Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.

The study aims at demonstrating if a correlation exists between the motor deficiency and the muscular deoxygenation in children suffering from neuromuscular disorders.

详细描述

Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls, as it was demonstrated in Becker muscular dystrophy patients and fascioscapulo humeral muscular dystrophy. Moreover, the deoxygenation kinetics was positively correlated to the functional status and the muscular deficiency severity. However, no pediatric study has been conducted on this topic up to date.

The aim of the study is to determine if a correlation exists in children suffering from neuromuscular diseases:

  • between muscular oxygenation and the percentage of the 6 minutes walking test performed in the routine medical care
  • between muscular oxygenation and the total and D1 motor function measure value

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children from 6 to 18 years-old suffering from a neuromuscular disorder
  • Able to walk, with or without help

排除标准

  • Hypoxia secondary to heart or lung disease
  • Visual impairment (<5/10)
  • Parents refusal concerning data storage

结局指标

主要结局

Muscular oxygenation

时间窗: 6 minutes

Muscular oximetry

次要结局

  • Motor function(25 minutes)
  • 6 minutes walking distance(6 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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