NCT04268017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

15 days

First QC Date

February 11, 2020

Last Update Submit

February 11, 2020

Conditions

Healthy

Keywords

Gait analysisFeetMe®GaitRite®HealthyValidation

Outcome Measures

Primary Outcomes (1)

  • Velocity measured through FeetMe Monitor device and GaitRit

    1 day

Secondary Outcomes (5)

  • Stride length measured through FeetMe Monitor device and GaitRite

    1 day

  • Cadence 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

Study Arms (1)

Healthy volunteer

EXPERIMENTAL
Device: FeetMe Monitor

Interventions

FeetMe MonitorDEVICE

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

Healthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Be part of another study
  • Not be able to give consent
  • Not have access to social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Créteil, 94000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

September 17, 2018

Primary Completion

October 2, 2018

Study Completion

October 2, 2018

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)