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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Gait Disorders, Neurologic

Intervention / Treatment
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* Device: FeetMe Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemiparetic patient<br>patients who had a stroke at least 6 months before inclusion | Device: FeetMe Monitor<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity measured through FeetMe Monitor device and GaitRite |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait analysis, Stroke, FeetMe, GaitRite