Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed

Not Applicable

Completed

• Conditions: Healthy

• 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

Study Timeline

• Study Start: 2018-09-17
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 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

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