Validity of Using Connected Soles In Measuring Steps Number In the Older Subject, Hospitalized in Follow-up and Rehabilitative Care and Achieve Its Rehabilitation Objectives (SEMCOPAGE)

The purpose of this study is to evaluate counting steps by connected soles worn in the shoes of subjects, having recovered the maximum walking capacities of patients . To answer the question asked in the study, it is planned to include 60 patients over 70 years of age.

Study Overview

• Status: Recruiting
• Conditions: Patient Recovering Maximum Walking Capacity, Over 10 Meter
• Intervention / Treatment: Device: Feetme Connected Soles

Detailed Description

The main objective of this interventional, monocentric, transverse, nonrandomized and prospective study is to assess the concordance of step counting between connected soles and video, in elderly subjects hospitalized in Follow-up and rehabilitation care, at Paul Brousse hospital, having recovered maximum walking capacities of participants, on 10 meters. After inclusion, following data will be collected : Measure blood pressure, heart rate, neurological and cardiological exam, pneumological exam, Short Physical Performance Battery Score Feetme connected soles comply with European standards (CE label no. 29762). The study will consist of 10-metre walk for patient during a rehabilitation session :

• By wearing the soles connected to patient's size (in patient's usual shoes). The recording of data will be triggered by an investigator, via an application downloaded on a smartphone. The application will trigger and stop the registration of soles.
• While being filmed by a camcorder mounted on a tripod (excluding the face) for footsteps. The test will be filmed (excluding the face) to avoid a measurement bias in counting steps. Two physician observers will view each patient's film in a second time in order to perform the step count. Before starting the walk, an on-site observer will ensure that the footings are set to 0 for counting step and that the recording is stopped after 10 metres. If this is deemed possible by the referring physiotherapist, the same protocol will then be carried out over 30 meters (new test: the patient who can do it will perform 40 meters in total (10 meters then test of 30 meters).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle Dufour; Phone Number: +33 (0) 185781010; Email: isabelle.dufour@gerondif.org
• Study Contact Backup: Name: Adrien Besseiche, PhD; Phone Number: +33 (0) 185781010; Email: adrien.besseiche@gerondif.org

Study Locations

• France
  • Ile-de-France
    • Villejuif, Ile-de-France, France, 94804
      • Recruiting
      • Geriatric Department - Paul Brousse Hospital
      • Contact: Emmanuelle Duron, MD; Phone Number: +33 (0) 145596943; Email: emmanuelle.duron@aphp.fr
      • Contact: Romain Artico; Phone Number: +33 (0) 145596943; Email: romain.artico@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >70 years olde
• Patients able to walk 10 meters
• Patients who received physiotherapy
• Patients able to understand instructions and freely consent (mini mental state examination (MMSE) ≥ 20
• Informed consent, major unprotected
• Membership in a social security scheme

Exclusion Criteria:

• Unable to walk the required distance (severe dyspnea, post-fall syndrome, blindness)
• Foot sores (bedsores or other)
• Patients participating in another intervention study
• Major patients protected or deprived of study freedom

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Connected soles; Number of steps recorded by the soles (activation per smartphone)	Device: Feetme Connected Soles; Walk for 10 meters (and 30meters): - By wearing the European Community (EC) labelled connected soles in patient's shoes, triggered by smartphonecollection of data by smartphone - By being filmed by a camera camera mounted on a tripod (excluding the face) for steps counting (2 observers). If there is a technical problem during the walk test, this one can be performed 1 time again 1 hour after initial test.This is expected to happen very rarely.
Active Comparator: Gold Standard; Number of steps counted by two observers viewing the film	Device: Feetme Connected Soles; Walk for 10 meters (and 30meters): - By wearing the European Community (EC) labelled connected soles in patient's shoes, triggered by smartphonecollection of data by smartphone - By being filmed by a camera camera mounted on a tripod (excluding the face) for steps counting (2 observers). If there is a technical problem during the walk test, this one can be performed 1 time again 1 hour after initial test.This is expected to happen very rarely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the concordance of the step count between the connected soles and the video	The main evaluation criterion is the number of steps taken by the patient to travel the distance of 10 meters. A ground marking will be done using a tape meter to highlight the distance of 10 meters.The number of steps will be counted using the connected soles and video.	3days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of steps number to cover the distance of 30 meters according connected soles and video		3 days
Assessment of soles comfort according Likert scale	The means between 1 and 2 are adjudged low, the means between 2 and 4 adjudged medium and the means between 4 and 5 adjudged high	3 days

Collaborators and Investigators

• Sponsor: Gérond'if
• Investigators: Study Chair: Emmanuelle Duron, MD, Geriatric Department - Paul Brousse Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Anticipated): November 19, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: steps; counting; Connected Soles
• Other Study ID Numbers: 2021-A01091-40

Drug and device information, study documents

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