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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life

Conditions
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Fragility

Intervention / Treatment
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* Device: smart insole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>30 frail volunteers of the control group in the second phase won't be equipped with the smart insole. | |
| Experimental: Intervention<br>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<br>* smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, Robust volunteers for the first phase;, tele-monitoring, self-management, Patient 65 and over, Presenting a frailty syndrome for the second phase