FragilityRESPECTNCT02316600
Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
A study testing smart insole in people with Fragility, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fragility
- What is being tested?
- smart insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fragility
- Being tested
- smart insole
- Keywords
- elderly, Robust volunteers for the first phase;, tele-monitoring, self-management, Patient 65 and over, Presenting a frailty syndrome for the second phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smart insoleDevice
smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 30 frail volunteers of the control group in the second phase won't be equipped with the smart insole. |
| Intervention | Experimental | 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 Receives: Device: smart insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of the solution
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:
- 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.
- Spontaneous use of data consultation interface (frequency)
Qualitative indicators:
Semi-structures interview conducted by the laboratory AGIM of the University Joseph Fournié
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJul 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FragilityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine PIAU, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316600
- Sponsor's protocol ID
- 13 6991 17
- Acronym
- RESPECT
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2014
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Piau A, Steinmeyer Z, Charlon Y, Courbet L, Rialle V, Lepage B, Campo E, Nourhashemi F. A Smart Shoe Insole to Monitor Frail Older Adults' Walking Speed: Results of Two Evaluation Phases Completed in a Living Lab and Through a 12-Week Pilot Study. JMIR Mhealth Uhealth. 2021 Jul 5;9(7):e15641. doi: 10.2196/15641.
PubMed 36260404Piau A, Charlon Y, Campo E, Vellas B, Nourhashemi F. A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results. JMIR Rehabil Assist Technol. 2015 May 25;2(1):e5. doi: 10.2196/rehab.4084.
PubMed 28582238
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
- ClinicalTrials.gov ID
- NCT02316600
- Acronym / sponsor ID
- RESPECT / 13 6991 17
- Conditions
- Fragility
- Keywords
- elderly, Robust volunteers for the first phase;, tele-monitoring, self-management, Patient 65 and over, Presenting a frailty syndrome for the second phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 15 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –30 frail volunteers of the control group in the second phase won't be equipped with the smart insole. |
| Intervention | Experimental | Device: smart insole30 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smart insolesmart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty | Device | Intervention |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Results publication: PubMed 36260404Piau A, Steinmeyer Z, Charlon Y, Courbet L, Rialle V, Lepage B, Campo E, Nourhashemi F. A Smart Shoe Insole to Monitor Frail Older Adults' Walking Speed: Results of Two Evaluation Phases Completed in a Living Lab and Through a 12-Week Pilot Study. JMIR Mhealth Uhealth. 2021 Jul 5;9(7):e15641. doi: 10.2196/15641.
- Results publication: PubMed 28582238Piau A, Charlon Y, Campo E, Vellas B, Nourhashemi F. A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results. JMIR Rehabil Assist Technol. 2015 May 25;2(1):e5. doi: 10.2196/rehab.4084.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine PIAU, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing smart insole in people with Fragility, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptability of the solution (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02316600, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.