Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life (RESPECT)

April 28, 2026 updated by: University Hospital, Toulouse
The investigators aim is to evaluate an instrument for supporting physical activity and monitors multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigators are therefore developing a smart shoe insole to monitor key parameters of frailty during subject daily life and to promote walking. Our primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficacy of the solution to prevent disability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The object of the present project is to promote the prevention of disability by providing 1) a feed-back and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The device consists of a smart, removable insole. It measures dynamic characteristics of gait (e.g., speed, variability, distance) as well as body weight modifications with minimal invasiveness. The insole transmits wireless the collected data to a storage server through a touchpad. Data will then be available for at distance consultations by users (i.e., patients or physicians). The investigators will conduct a wide range of evaluations of the device (technical, clinical, social, ergonomic, and economic), which will allow the optimization of the prototype. The evaluation of the prototypes will preliminary takes place at the Blagnac smart house. 10 healthy volunteers will test the device. The second evaluation phase will involve 60 frail community-dwelling subjects, with 30 of them which will use the smart insoles for 3 months. Comprehensive assessments will be conducted to highlight the feasibility, acceptability, interoperability, integration in healthcare network, and clinical relevance of the technological device in comparison to usual care.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Midi-Pyrenes
      • Toulouse, Midi-Pyrenes, France, 31059
        • University Hospital, Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient aged 65 or more, living at home;
  • Presenting a frailty syndrome for the second phase, and robust volunteers for the first phase;
  • Informed and written consent by the patient or the legal representative or the reliable person when appropriate.

Exclusion Criteria:

  • No access to ADSL;
  • Patient's life expectancy less than 12 months;
  • Patient presenting disability with an Activity of Daily Living score < 4/6 and/or a Mini Mental State <24/30;
  • Non agreement of study participation of patients or legal representative or the reliable person when appropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
30 frail volunteers of the control group in the second phase won't be equipped with the smart insole.
Experimental: Intervention
30 frail volunteers of the intervention group in the second phase will be equipped with the smart insole for 3 months, to encourage the frail elderly person's physical activity and to monitor key parameters of frailty
Device: smart insole
smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptability of the solution
Time Frame: 3 months

based on the acceptability of the solution for the user which will be assessed in the intervention group by: quantitative and qualitative indicators

Quantitative indicators:

  1. Proportion of hours which the subject is awake and actually wears the smart shoe insole. This information will be collected by semi-structured interview and records actimetry of the solution.
  2. Spontaneous use of data consultation interface (frequency)

Qualitative indicators:

Semi-structures interview conducted by the laboratory AGIM of the University Joseph Fournié
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Antoine PIAU, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimated)

December 15, 2014

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13 6991 17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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