A review of the design and clinical evaluation of the ShefStim array-based functional electrical stimulation system

Kenney, LPJ; Heller, B; Barker, A; Reeves, M; Healey, J; Good, T; Cooper, G; Sha, N; Prenton, S; Liu, A; Howard, D

Abstract

Functional electrical stimulation has been shown to be a safe and effective means of correcting foot drop of central neurological origin. Current surface-based devices typically consist of a single channel stim- ulator, a sensor for determining gait phase and a cuff, within which is housed the anode and cathode. The cuff-mounted electrode design reduces the likelihood of large errors in electrode placement, but the user is still fully responsible for selecting the correct stimulation level each time the system is donned. Researchers have investigated different approaches to automating aspects of setup and/or use, including recent promising work based on iterative learning techniques. This paper reports on the design and clini- cal evaluation of an electrode array-based FES system for the correction of drop foot, ShefStim. The paper reviews the design process from proof of concept lab-based study, through modelling of the array geome- try and interface layer to array search algorithm development. Finally, the paper summarises two clinical studies involving patients with drop foot. The results suggest that the ShefStim system with automated setup produces results which are comparable with clinician setup of conventional systems. Further, the final study demonstrated that patients can use the system without clinical supervision. When used un- supervised, setup time was 14 min (9 min for automated search plus 5 min for donning the equipment), although this figure could be reduced significantly with relatively minor changes to the de

• Journal Article Type: Article
• Acceptance Date: Aug 13, 2016
• Online Publication Date: Sep 14, 2016
• Publication Date: Nov 1, 2016
• Deposit Date: Oct 31, 2016
• Publicly Available Date: Sep 14, 2017
• Journal: Medical Engineering & Physics
• Print ISSN: 1350-4533
• Publisher: Elsevier
• Volume: 38
• Issue: 11
• Pages: 1159 -1165
• DOI: https://doi.org/10.1016/j.medengphy.2016.08.005
• Publisher URL: http://dx.doi.org/10.1016/j.medengphy.2016.08.005
• Related Public URLs: http://www.journals.elsevier.com/medical-engineering-and-physics/
• Additional Information: Funders : National Institute for Health Research (NIHR);Sheffield Hospitals Charitable Trust;UK Overseas Research Studentship; Grant Number: HTD480