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• Status: Withdrawn
• Conditions: Patient Recovering Maximum Walking Capacity, Over 10 Meters
• 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
• Phase: Not Applicable

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
• Masking: NONE

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 smartphone- collection 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 smartphone- collection 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 steps number to cover the distance of 10 meters according connected soles	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. The soles count the step thanks to the foot pressure and the data are collected on smartphone. A video will be recorded simultaneously (fluted face) during the walk.	3 days

Secondary Outcome Measures

Outcome Measure	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	3 days

Collaborators and Investigators

• Sponsor: Gérond'if

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): May 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: July 12, 2019
• First Posted (ACTUAL): July 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 19, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: steps; counting; Connected Soles
• Other Study ID Numbers: 2018-A03468-47

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