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OpenTrials
Completed

NCT Number: NCT06027762

Assessment of vGRF 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) .

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Key information

Conditions

Healthy Volunteers

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopitaux Saint-Maurice

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

FeetMe

Industry

Collaborators

  • Hopitaux de Saint-Maurice

Registry information

Official study title

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

Acronym: FeetMe-GRF

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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