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

FeetMe30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

For gait parameters' evaluation, the investigator asks the participant to move in a straight line over a 10-meter mat. The participant had to start the feet in line and then start walking at a comfortable speed. During this time, the investigator records the gait parameters from the FeetMe Monitor® and Gaitrite® system. An operator asked the patient to repeat 3 trials. The same sequence was repeated by three other operators. The same measurement is done 7 days later. A questionnaire is given to assess the ergonomics of the device

Eligibility

Min age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris

Créteil, France

Outcomes

Primary Outcomes

Velocity measured through FeetMe Monitor device and GaitRit

Time frame: 1 day

Secondary Outcomes

Stride length measured through FeetMe Monitor device and GaitRite

Time frame: 1 day

Cadence measured through FeetMe Monitor device and GaitRite

Time frame: 1 day

Stance phase measured through FeetMe Monitor device and GaitRite

Time frame: 1 day

Swing phase measured through FeetMe Monitor device and GaitRite

Time frame: 1 day

Stride duration measured through FeetMe Monitor device and GaitRite

Time frame: 1 day

Data from ClinicalTrials.gov

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