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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)

G

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Withdrawn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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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