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

Not Applicable

Completed

• Conditions: Stroke; Gait Disorders, Neurologic
• Interventions: Device: FeetMe Monitor

• Registration Number: NCT04266743
• Lead Sponsor: FeetMe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Primary Completion: 2019-03-18
• Study Completion: 2019-03-18
• Study First Submitted: 2020-01-28
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-12
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemiparetic patient	FeetMe Monitor	patients who had a stroke at least 6 months before inclusion

Primary Outcome Measures

Name	Time	Method
Velocity measured through FeetMe Monitor device and GaitRite	1 day

Secondary Outcome Measures

Name	Time	Method
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
Stride length measured through FeetMe Monitor device and GaitRite	1 day

Trial Locations

Locations (1)

Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Créteil, France