Study of New Self-Charging Smart Insoles With AI to Monitor Health Biometrics in Adults

What this Trial Is About

Researchers are evaluating newly developed self-powered, smart insoles designed for remote patient monitoring in both military and civilian populations. This study aims to assess the comfort, durability, and sensor accuracy of two generations of these medical-grade insoles, funded by SEMI and the Air Force Research Laboratory. The investigation focuses on how well these insoles can measure physiological biomarkers safely and accurately over time. The study is conducted in two phases. Phase 1 involves a pilot test of generation 1.0 insoles with 10 participants walking at different speeds on a treadmill and over a half-mile course on a university campus. Phase 2 evaluates generation 2.0, which features an improved energy harvester, first with a similar 10-person pilot and then a larger field study involving 100 participants who will wear the insoles at home for 4 weeks. Both phases include close monitoring and data collection through a mobile app and embedded sensors. Participants will be asked to attend four weekly visits over the 4-week period, during which their safety and the accuracy of the sensors in measuring biomarkers will be assessed. The study will monitor sensor performance and participant experience throughout the observation period. Data collected will include physical activity and biometric information, supporting evaluation of the insoles effectiveness and safety for extended use in daily life.

Novel Self-charging, Medical-Grade Smart Insoles With AI/ML Edge Computing to Monitor Biometrics.