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

FeetMe

Status: Completed

Conditions: Healthy

Treatments: Device: FeetMe Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04268017

FTM_HEALTHY_01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Healthy volunteer

Experimental group

Treatment:

Device: FeetMe Monitor