Clinical trial NCT04022356: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Patient Recovering Maximum Walking Capacity, Over 10 Meters
Keywords: counting
steps
Connected Soles
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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).

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of steps number to cover the distance of 10 meters according connected soles
timeFrame: 3 days
Secondary outcomes:
measure: Assessment of steps number to cover the distance of 30 meters according connected soles and video
timeFrame: 3 days
measure: Assessment of soles comfort according Likert scale
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
References: