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

Not Applicable

Terminated

• Conditions: Healthy
• Interventions: Device: FeetMe

• Registration Number: NCT05536687
• Lead Sponsor: FeetMe

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-09
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Last Update Submitted: 2022-09-08
• Study First Posted: 2022-09-13
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy	FeetMe	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Ch Delafontaine; 🇫🇷 Saint-Denis, France