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

NCT ID: NCT05536687

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-06-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy

Group Type: OTHER

FeetMe

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

FeetMe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ch Delafontaine

Saint-Denis, , France

Countries

France

Other Identifiers

ValiFeet6

Identifier Type: -

Identifier Source: org_study_id