Clinical trial NCT02316600: Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
Official title: Mobility Assessment & Follow-up in Frail Elderly: Clinic-technical Validation of a Smart Insole in Real Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-12-15
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: acceptability of the solution
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrenes
Study officials:
affiliation: University Hospital, Toulouse
name: Antoine PIAU, MD
role: PRINCIPAL_INVESTIGATOR
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