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