跳至主要内容
临床试验/NCT04268017
NCT04268017已完成不适用

Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects

FeetMe2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月17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
FeetMe
入组人数
30
试验地点
2
主要终点
Velocity measured through FeetMe Monitor device and GaitRit

研究概览

简要总结

The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the volunteer is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Healthy volunteers have two measurements 7 days apart. The volunteer repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the volunteer.

研究设计

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

入排标准

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

入选标准

  • Have more than 18 years old
  • Don't be pregnant or breast feeding

排除标准

  • Be part of another study
  • Not be able to give consent
  • Not have access to social security

结局指标

主要结局

Velocity measured through FeetMe Monitor device and GaitRit

时间窗: 1 day

次要结局

  • Cadence measured through FeetMe Monitor device and GaitRite(1 day)
  • Stride length measured through FeetMe Monitor device and GaitRite(1 day)
  • Stance phase measured through FeetMe Monitor device and GaitRite(1 day)
  • Swing phase measured through FeetMe Monitor device and GaitRite(1 day)
  • Stride duration measured through FeetMe Monitor device and GaitRite(1 day)

研究者

发起方
FeetMe
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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