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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Device: FeetMe

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Denis, France, 93200
    • Ch Delafontaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the test-retest for the distance during a 6MWT	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).	10 days

Collaborators and Investigators

• Sponsor: FeetMe

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Healthy; insoles; 6MWT; Real-world
• Other Study ID Numbers: ValiFeet6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No