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)

Gérond'if

Status: Withdrawn

Conditions: Patient Recovering Maximum Walking Capacity, Over 10 Meters

Treatments: Device: Feetme Connected Soles

Study type: Interventional

Funder types: Other

Identifiers

NCT04022356

2018-A03468-47

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Connected soles

Experimental group

Description:

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

Treatment:

Device: Feetme Connected Soles

Gold Standard

Active Comparator group

Description:

Number of steps counted by two observers viewing the film

Treatment:

Device: Feetme Connected Soles