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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06027762

Acronym

FeetMe-GRF

Enrollment

Registered

2023-09-07

Start date

2022-02-01

Completion date

2022-11-30

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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) .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results