NCT04266743已完成不适用
FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke
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 GaitRite
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 for a pathologic gait. 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 patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient 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 patient.
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）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have more than 18 years old
- •Don't be pregnant or breast feeding
- •Have a stroke for more than 6 months
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 GaitRite
时间窗: 1 day
次要结局
- Cadence 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)
- Stride length measured through FeetMe Monitor device and GaitRite(1 day)
研究者
研究点 (2)
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