Assessment of vGRF Measurement During Walking With Feetme... | NCT06027762

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

NCT06027762

Sponsor

FeetMe

Status

Completed

Last Update Posted

Sep 7, 2023Actual

Enrollment

37Actual

Phase

Not provided

Conditions

Healthy Volunteers

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2022Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Aug 31, 2023

First Submission Date that Met QC Criteria

Aug 31, 2023

First Posted Date

Sep 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2023

Last Update Posted Date

Sep 7, 2023Actual

Name	Class
Hopitaux de Saint-Maurice	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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) .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Label	Type	Description	Intervention Names
Single-Groupe

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Adults between 18 and 85 years old without gait pathologies

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hopitaux Saint-Maurice		Saint-Maurice	Île-de-France Region	94410	France

IPD Sharing Statement Module

Plan to Share IPD

Description

legal reasons

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided