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

NCT04268017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-02-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

FeetMe Monitor

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

Sponsors & Collaborators

  • FeetMe

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2018-10-02
Completion
2018-10-02

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268017 on ClinicalTrials.gov