NCT05536687

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: FeetMe · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2022-09-13
• Last updated: 2022-09-13

Locations

1 site across 1 country: France