Innovative single-sensor, in-shoe pressure and temperature monitoring device : a dynamic laboratory validation study

Abstract

Background: Available technology to detect the 2 primary predictors of ulceration is not being used as it is deemed as costly and time-consuming. Thus, the aim of this study was to determine dynamic laboratory validation, of an innovative, single-sensor in-shoe device that can read peak pressure and temperature simultaneously. Research question: Can an innovative, newly developed, in-shoe pressure and temperature measuring device, detect and measure the in-shoe peak plantar pressures and skin temperature of healthy participants, as accurately as the reference standard? Methods: Five healthy adult participants were recruited. The prototype was validated against the gold standard FScan™ in-shoe system for pressures and the Flir® T630sc thermographic camera for temperatures. Participants were asked to walk at a comfortable pace on an electric treadmill for 13 minutes. The prototype and the FScan in-shoe sensors™ were superimposed inside the shoe of the participant, with the prototype on top, to ensure direct contact with the area of interest. Two thermographic images were captured using the Flir® T630sc thermographic camera, before and after the walk. During the trials, the participants wore 100% cotton socks and their own sports shoes and pressures were recorded at 50 readings a second. Results: The raw readings of pressure were passed to the regressor, which returned the estimated kPa value. Several evaluations metrics were used to evaluate the performance of the modal. The prototype gave equal results to that of the gold standard, the FScan™ in-shoe system. With regards to temperature measurements, both devices gave similar readings. Significance: This innovative single-sensor, in-shoe pressure and temperature monitoring device showed similar measurements of pressure to the FScan™ system and temperature measurements were equivalent to the Flir® T630sc thermographic camera. The authors are confident that the innovative, low cost, single-sensor, in-shoe pressure and temperature monitoring device can Journal Pre-proof be used as an alternative to the costly available commercial devices that measure pressure and temperature separately to detect early signs of complications in the high-risk foot.