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

NCT06027762 | Completed

• 1 other identifier: 2021-A02409-32
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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) .

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single-Groupe

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Adults between 18 and 85 years old without gait pathologies

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• FeetMe: lead
• Hopitaux de Saint-Maurice: collaborator

Study Sites (1)

Hopitaux Saint-Maurice

Saint-Maurice, Île-de-France Region, 94410, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 7, 2023
• Study Start: February 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)