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

NCT05535374 | Unknown DMC

• 1 other identifier: 2021-A01091-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 Meter

Keywords

counting; steps; Connected Soles

Outcome Measures

Primary Outcomes (1)

• 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 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 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.

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 Sites (1)

Geriatric Department - Paul Brousse Hospital

Villejuif, Île-de-France Region, 94804, France

RECRUITING

Study Officials

• Emmanuelle Duron, MD

  Geriatric Department - Paul Brousse Hospital

  STUDY CHAIR

Central Study Contacts

Isabelle Dufour

CONTACT

+33 (0) 185781010; isabelle.dufour@gerondif.org

Adrien Besseiche, PhD

CONTACT

+33 (0) 185781010; adrien.besseiche@gerondif.org

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: April 13, 2022
• First Posted: September 10, 2022
• Study Start: January 6, 2022
• Primary Completion: November 19, 2023
• Study Completion: January 31, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

FR (1)