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

FeetMe

Status: Completed

Conditions: Stroke; Gait Disorders, Neurologic

Treatments: Device: FeetMe Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT04266743

FTM_HEMI_01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hemiparetic patient

Experimental group

Description:

patients who had a stroke at least 6 months before inclusion

Treatment:

Device: FeetMe Monitor