Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
- Conditions
- Healthy
- Interventions
- Device: FeetMe Monitor
- Registration Number
- NCT04268017
- Lead Sponsor
- FeetMe
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Not specified
- Target Recruitment
- 30
- Have more than 18 years old
- Don't be pregnant or breast feeding
- Be part of another study
- Not be able to give consent
- Not have access to social security
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Healthy volunteer FeetMe Monitor -
- Primary Outcome Measures
Name Time Method Velocity measured through FeetMe Monitor device and GaitRit 1 day
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
🇫🇷Créteil, France