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

NCT04022356 | Withdrawn DMC

• 1 other identifier: 2018-A03468-47
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Patient Recovering Maximum Walking Capacity, Over 10 Meters

Keywords

counting; steps; Connected Soles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Connected soles

EXPERIMENTAL

Number of steps recorded by the soles (activation per smartphone)

Device: Feetme Connected Soles

Gold Standard

ACTIVE COMPARATOR

Number of steps counted by two observers viewing the film

Device: Feetme Connected Soles

Interventions

Feetme Connected Soles DEVICE

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.

Connected soles; Gold Standard

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gérond'if: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: July 17, 2019
• Study Start: June 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: July 1, 2021
• Last Updated: April 19, 2022

Record last verified: 2022-04