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

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

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) .

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• France
  • Ile-de-France
    • Saint-Maurice, Ile-de-France, France, 94410
      • Hopitaux Saint-Maurice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults between 18 and 85 years old without gait pathologies

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single-Groupe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: FeetMe
• Collaborators: Hopitaux de Saint-Maurice

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021-A02409-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: legal reasons

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No