Design of a Smartphone Application with Integrated Functional Electrical Stimulation (FES) Treatment Randomization and On-The-Fly Stimulus Parameter Adjustment for Streamlining the Clinical Evaluation of FES Protocols

The clinical application of Functional Electrical Stimulation (FES) has evolved over the last five decades. However, the use of the Randomized Control Trial (RCT) methodology in evaluating the clinical effectiveness of new and existing applications of FES is a demanding process adding time and cost to these trials. Consequently, there has been a low level of RCTs applied to FES studies. Poor quality trials result in poor evidence of FES effectiveness with a consequence that the technique may not be adopted into clinical practice. In this paper some of the key challenges encountered in FES randomised control clinical trials are identified and a solution to address these challenges is presented in the form of a smartphone App and a Bluetooth controlled FES architecture. The design and evaluation of a smartphone application using a User Centred Design approach to provide automatic blind randomization control and facilitating the wireless temporal control of a portable Bluetooth enabled FES device is described.