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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Assessment of steps number to cover the distance of 10 meters according connected soles
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Assessment of steps number to cover the distance of 10 meters according connected soles
Time Frame: 3 days
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. 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 Outcomes
- Assessment of soles comfort according Likert scale(3 days)
- Assessment of steps number to cover the distance of 30 meters according connected soles and video(3 days)