FeetMe® Monitor: Alternative for the Evaluation of Gait Speed After Stroke

Sponsor

FeetMe (Industry)

Overall Status

Completed

CT.gov ID

NCT04266743

Collaborator

(none)

Enrollment

Location

Arm

4.6

Actual Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite for a pathologic gait. 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 patient is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Hemiparetic patients have two measurements 7 days apart. The patient 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 patient.

Condition or Disease	Intervention/Treatment	Phase
Stroke Gait Disorders, Neurologic	Device: FeetMe Monitor	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

FeetMe® Monitor Connected Insoles Are a Valid and Reliable Alternative for the Evaluation of Gait Speed After Stroke

Actual Study Start Date :

Oct 29, 2018

Actual Primary Completion Date :

Mar 18, 2019

Actual Study Completion Date :

Mar 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemiparetic patient patients who had a stroke at least 6 months before inclusion	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

Arm

Intervention/Treatment

Experimental: Hemiparetic patient

patients who had a stroke at least 6 months before inclusion

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

Outcome Measures

Primary Outcome Measures

Velocity measured through FeetMe Monitor device and GaitRite [1 day]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have more than 18 years old
Don't be pregnant or breast feeding
Have a stroke for more than 6 months

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris	Créteil		France	94000

Sponsors and Collaborators

FeetMe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

FeetMe

ClinicalTrials.gov Identifier:

NCT04266743

Other Study ID Numbers:

FTM_HEMI_01

First Posted:

Feb 12, 2020

Last Update Posted:

Feb 12, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by FeetMe

Additional relevant MeSH terms:

Stroke

Nervous System Diseases

Gait Disorders, Neurologic

Study Results

No Results Posted as of Feb 12, 2020