FITFES: A Wearable Myoelectrically Controlled Functional Electrical Stimulator Designed Using a User-Centered Approach

Myoelectrically Controlled Functional Electrical Stimulation (MeCFES) has proven to be a useful tool in the rehabilitation of the hemiplegic arm. This paper reports the steps involved in the development of a wearable MeCFES device (FITFES) through a user-centered design. We defined the minimal viable features and functionalities requirements for the device design from a questionnaire-based survey among physiotherapists with experience in functional electrical stimulation. The result was a necklace layout that poses minimal hindrance to task-oriented movement therapy, the context in which it is aimed to be used. FITFES is battery-powered and embeds a standard low power Bluetooth module, enabling wireless control by using PC/Mobile devices vendor specific built-in libraries. It is designed to deliver a biphasic, charge-balanced stimulation current pulses of up to 113 mA with a maximum differential voltage of 300 V. The power consumption for typical clinical usage is 320 mW at 20mA stimulation current and of less than
$10~\mu \text{W}$
in sleep mode, thus ensuring an estimated full day of FITFES therapy on a battery charge. We conclude that a multidisciplinary user-centered approach can be successfully applied to the design of a clinically and ergonomically viable prototype of a wearable myoelectrically controlled functional electrical stimulator to be used in rehabilitation.