A Smart Insole to Promote Healthy Aging for Frail Elderly Individuals: Specifications, Design, and Preliminary Results.

Background: Older individuals frequently experience reversible "frailty syndrome,", increasing incidence of disability. Although physical exercise interventions may delay functional decline, there are difficulties in implementing them and performing seamless follow-up at home. Very few technological solutions attempt to address this challenge and improve individual participation.

Objective: Our objectives are to (1) develop a technological solution designed to support active aging of frail older persons, (2) conduct a first laboratory evaluation of the device, and (3) design a multidimensional clinical trial to validate our solution.

Methods: We conducted a first phase of multidisciplinary meetings to identify real end users and health professional's unmet needs, and to produce specifications for the architecture of the solution. In a second phase, we performed laboratory tests of the first proposed prototype (a smart insole) with 3 healthy volunteers. We then designed an ongoing clinical trial to finalize the multidimensional evaluation and improvement of the solution.

Results: To respond to the needs expressed by the stakeholders (frailty monitoring and adherence improvement), we developed a prototype of smart shoe insole to monitor key parameters of frailty during daily life and promote walking. It is a noninvasive wireless insole, which automatically measures gait parameters and transmits information to a remote terminal via a secure Internet connection. To ensure the solution's autonomy and transparency, we developed an original energy harvesting system, which transforms mechanical energy produced by the user's walking movement into electrical energy. The first laboratory tests of this technological solution showed good reliability measures and also a good acceptability for the users. We have planned an original iterative medical research protocol to validate our solution in real life.

Conclusions: Our smart insole could support preventive strategies against disability in primary care by empowering the older patients without increasing the busy health professional's workload.

Trial Registration: Clinicaltrials.gov NCT02316600; https://clinicaltrials.gov/ct2/results?term=NCT02316600&Search=Search. Accessed: 2015-05-13 . (Archived by WebCite at http://www.webcitation.org/6YUTkObrQ).