Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
NCT ID: NCT04268017
Last Updated: 2020-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-09-17
2018-10-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Healthy volunteer
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Don't be pregnant or breast feeding
Exclusion Criteria
* Not be able to give consent
* Not have access to social security
18 Years
Yes
Sponsors
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FeetMe
INDUSTRY
Responsible Party
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Locations
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Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
Créteil, , France
Countries
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Other Identifiers
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FTM_HEALTHY_01
Identifier Type: -
Identifier Source: org_study_id
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