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

February 11, 2020 updated by: FeetMe

Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France, 94000
        • Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Velocity measured through FeetMe Monitor device and GaitRit
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Stride length measured through FeetMe Monitor device and GaitRite
Time Frame: 1 day
1 day
Cadence measured through FeetMe Monitor device and GaitRite
Time Frame: 1 day
1 day
Stance phase measured through FeetMe Monitor device and GaitRite
Time Frame: 1 day
1 day
Swing phase measured through FeetMe Monitor device and GaitRite
Time Frame: 1 day
1 day
Stride duration measured through FeetMe Monitor device and GaitRite
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FeetMe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

October 2, 2018

Study Completion (Actual)

October 2, 2018

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FTM_HEALTHY_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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