Development of a functional prototype of a SMART (Sensor-integrated for Monitoring And Remote Tracking) foot abduction brace for clubfoot treatment: a pre-clinical evaluation

Purpose: Recurrences following clubfoot correction by the Ponseti method can be prevented by regular use of a foot abduction brace (FAB) until the child is four to five years old. However, there is a lack of an objective method to measure actual hours of brace usage. The aim was to develop a functional prototype of a SMART (Sensor-integrated for Monitoring And Remote Tracking) clubfoot brace to record accurate brace usage and transmit the data remotely to healthcare providers treating clubfoot. Methods: A collaborative team of engineers and doctors was formed to investigate various types of sensors and wireless technologies to develop a functional prototype of a SMART brace. Results: Infrared sensors were used to detect if the feet were placed inside the shoes and magnetic Hall effect sensors to detect that the shoes were latched on to the bar of the existing FAB. Brace usage data were captured by the sensors every 15 minutes and stored locally on a data card. A Bluetooth low energy (BLE)-based wireless transmission system was used to send the data daily from the brace to the remote cloud server via a smartphone application. Accurate brace usage data could be recorded by the sensors and visualized in real time on a web-based application in a pre-clinical setting, demonstrating feasibility in clinical practice. Conclusion: The low-cost SMART brace prototype that we have developed can accurately measure and remotely transmit brace usage data and has the potential to transform caregivers’ behaviour towards brace adherence, which could result in a tangible reduction in recurrence rates.