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临床试验/NCT03223051
NCT03223051已完成不适用

Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy

Centre d'Investigation Clinique et Technologique 8054 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年9月7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
30
试验地点
4
主要终点
Motor Function Measure (MFM)

研究概览

简要总结

The aim of this randomized study is to develop a new motor assessment of space exploration in a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3 until 16 years old.

详细描述

Thirty children are included in the prospective randomized study. They are evaluated with the new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold standard scale. The objective is to compare the results and to demonstrate the complementarity of the two tools.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • children, girls and boys, from 3 to 16 years old,
  • with Spinal Motor Atrophy 1 and 2
  • with social protection

排除标准

  • cognitive disorders preventing understanding

结局指标

主要结局

Motor Function Measure (MFM)

时间窗: 1 hour

Clinical Evaluation

次要结局

  • Space Exploration Test (SET)(20 minutes)

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 (4)

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