Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed

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 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.

Official Title
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Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects

Conditions
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Healthy

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 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


Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Healthy volunteer<br> | 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 GaitRit |  | 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, FeetMe®, GaitRite®, Healthy, Validation