ValiFeet6: VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES

Sponsor

FeetMe (Industry)

Overall Status

Terminated

CT.gov ID

NCT05536687

Collaborator

(none)

Enrollment

Location

Arm

8.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Currently, the guidelines for performing the 6MWT established by the American Thoracic Society and the European Respiratory Society (ATS/ERS) recommend the use of an indoor or outdoor corridor with a 30 m flat surface (6MWT30) for patients with respiratory diseases, which is also a recommendation for healthy adults. However, not all hospitals, nursing homes or clinics have a corridor of sufficient length to properly perform the 6MWT. A simple way to make the test available to more health care professionals would be to reduce the length of the hallway.

In times when access to the hospital is difficult, the ability to assess functional abilities at a distance becomes essential. Today, this is becoming possible with tools such as connected watches, accelerometers, connected shoes and insoles. They give access to a quantitative analysis of walking without necessarily requiring large spaces, specialized personnel or even being in a hospital environment. The FeetMe® Evaluation device consists of connected insoles as well as a mobile application allowing the evaluation of standard clinical walking tests.

This device allows a better understanding of patients' walking and is transposable in real life.

The objective of the present study is to demonstrate the validity and reliability of the measurement of the distance walked during a 6-minute test with connected insoles in standard conditions (6MW30), degraded conditions (6MW10) in a clinic and at home in a healthy population divided into age subgroups.

In addition, this study will investigate whether there is a relationship between 6 minutes of uncontrolled walking from real-life walking data and a standard 6-minute test.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: FeetMe	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

VALIDITY AND RELIABILITY OF THE 6-MINUTES WALKING TEST EVALUATED BY FEETME® INSOLES

Actual Study Start Date :

Oct 1, 2021

Actual Primary Completion Date :

Jun 30, 2022

Actual Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Healthy	Device: FeetMe Healthy volunteers will wear the insoles at 2 visits in hospitals (D0 and D8) and 2 visits at home (D1 and D7). The visits at the hospital will be composed of 3 tests of 6 min. in various conditions in a hospital environment : In degraded conditions, i.e. a 10m corridor, evaluated simultaneously by the FeetMe® system and an evaluator In degraded condition, a 10m corridor, evaluated simultaneously by the FeetMe® system and an odometer and evaluator Under the conditions recommended for the 6-minute test (ref), i.e. a 30m corridor, evaluated simultaneously by the FeetMe® system and the evaluator A rest time of 15 min minimum will be respected between each test. The visits at home will be composed of a 6-minute test at home or outdoors (quiet place, flat, hard surface, few or no passages, ideally no obstacles, covered if weather conditions are not suitable) with a 10-meter track that you can define simply with equipment provided by the promoter.

Arm

Intervention/Treatment

Other: Healthy

Device: FeetMe

Healthy volunteers will wear the insoles at 2 visits in hospitals (D0 and D8) and 2 visits at home (D1 and D7). The visits at the hospital will be composed of 3 tests of 6 min. in various conditions in a hospital environment : In degraded conditions, i.e. a 10m corridor, evaluated simultaneously by the FeetMe® system and an evaluator In degraded condition, a 10m corridor, evaluated simultaneously by the FeetMe® system and an odometer and evaluator Under the conditions recommended for the 6-minute test (ref), i.e. a 30m corridor, evaluated simultaneously by the FeetMe® system and the evaluator A rest time of 15 min minimum will be respected between each test. The visits at home will be composed of a 6-minute test at home or outdoors (quiet place, flat, hard surface, few or no passages, ideally no obstacles, covered if weather conditions are not suitable) with a 10-meter track that you can define simply with equipment provided by the promoter.

Outcome Measures

Primary Outcome Measures

Reliability of the test-retest for the distance during a 6MWT [10 days]
Compare the reliability of the test-retest for the distance evaluated by the FeetMe® solution during a 6MWT10 performed at home (6MWT10-Home) compared to a 6MWT10 performed in a hospital setting (6MWT10-Hospital).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Being between 18 and 80 years old
Able to use a laptop
Able to walk 100 meters without any aid
Accustomed to using a smartphone

Exclusion Criteria:

Surgery with the possibility of impacting gait in the previous 3 months having had an impact on gait: orthopedic surgery, trauma of the lower limbs and spine, gynecological or urological surgery, brain and spinal cord surgery • Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ch Delafontaine	Saint-Denis		France	93200

Sponsors and Collaborators

FeetMe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

FeetMe

ClinicalTrials.gov Identifier:

NCT05536687

Other Study ID Numbers:

ValiFeet6

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by FeetMe

Study Results

No Results Posted as of Sep 13, 2022