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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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04022356
Acronym
SEMCOPAGE
Enrollment
0
Registered
2019-07-17
Start date
2020-06-30
Completion date
2021-07-31
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Recovering Maximum Walking Capacity, Over 10 Meters

Keywords

counting, steps, Connected Soles

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.

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).

Interventions

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.

Sponsors

Gérond'if
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of steps number to cover the distance of 10 meters according connected soles3 daysThe 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.

Secondary

MeasureTime frame
Assessment of steps number to cover the distance of 30 meters according connected soles and video3 days
Assessment of soles comfort according Likert scale3 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026