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NCT06027762 Clinical Trial

Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults

Healthy Volunteers Clinical Trial

— FeetMe-GRF  

Official title:
Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06027762
Other study ID # 2021-A02409-32
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date November 30, 2022

Study information
Verified date August 2023
Source FeetMe
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) .

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date November 30, 2022
Est. primary completion date November 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria. Volunteers with following criteria satisfied: - Between the ages of 18 and 80. - Shoe size between 35 to 46. - Body weight from 40kg to 120kg. - Able to walk for 30 mins without assistance. - Comfortable with using a smartphone. Non-inclusion Criteria. A volunteer will not be included if one of the following conditions is met: - cognitive or behavioral problems limiting communication or participation in the study - deprivation of liberty by a legal or administrative decision - adults subject to a legal protection measure or unable to express their consent - pregnant, parturient and nursing mothers - people admitted to a health or social establishment for purposes other than research - Past or planned surgery with the possibility of impacting walking in the past 3 months or which had an impact on walking: orthopedic surgery, trauma to the lower limbs and spine, urological or gynecological surgery, brain and spinal cord surgery . - Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hopitaux Saint-Maurice Saint-Maurice Ile-de-France

Sponsors (2)
Lead Sponsor Collaborator
FeetMe Hopitaux de Saint-Maurice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles The primary objective of this clinical trial is to quantify precision of measurement of two peaks of vGRF, peaks that correspond to 'maximum weight acceptance' and 'push-off', also called 'heelmax load' and 'toemax load' for healthy adults by FeetMe® insoles compared with Vicon and force plates during a free walk test. between February 2022 and November 2022
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