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

NCT ID: NCT06027762

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-11-30

Brief Summary

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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

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Conditions

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Healthy Volunteers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single-Groupe

No interventions assigned to this group

Eligibility Criteria

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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.


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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hopitaux de Saint-Maurice

OTHER

Sponsor Role collaborator

FeetMe

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hopitaux Saint-Maurice

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

Site Status

Countries

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France

Other Identifiers

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2021-A02409-32

Identifier Type: -

Identifier Source: org_study_id

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