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FeetMe-GRF: Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults

Sponsor
FeetMe (Industry)
Overall Status
Completed
CT.gov ID
NCT06027762
Collaborator
Hopitaux de Saint-Maurice (Other)
37
Enrollment
1
Location
9.9
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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) .

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    37 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults
    Actual Study Start Date :
    Feb 1, 2022
    Actual Primary Completion Date :
    Nov 30, 2022
    Actual Study Completion Date :
    Nov 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Single-Groupe

    Outcome Measures

    Primary Outcome Measures

    1. precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles [between February 2022 and November 2022]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopitaux Saint-Maurice Saint-Maurice Ile-de-France France 94410

    Sponsors and Collaborators

    • FeetMe
    • Hopitaux de Saint-Maurice

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FeetMe
    ClinicalTrials.gov Identifier:
    NCT06027762
    Other Study ID Numbers:
    • 2021-A02409-32
    First Posted:
    Sep 7, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Sep 7, 2023