title: A review of the design and clinical evaluation of the ShefStim array-based functional electrical stimulation system.
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 stimulator, 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 clinical 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 geometry 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 unsupervised, setup time was 14min (9min for automated search plus 5min for donning the equipment), although this figure could be reduced significantly with relatively minor changes to the design.
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK. Electronic address: l.p.j.kenney@salford.ac.uk.
authors.forename: Laurence P
authors.initials: LP
authors.lastname: Kenney
authors.affiliation: Centre for Sports Engineering Research, Sheffield Hallam University, Sheffield S1 1WB, UK.
authors.forename: Ben W
authors.initials: BW
authors.lastname: Heller
authors.affiliation: Department of Medical Physics and Clinical Engineering, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
authors.forename: Anthony T
authors.initials: AT
authors.lastname: Barker
authors.affiliation: Department of Medical Physics and Clinical Engineering, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
authors.forename: Mark L
authors.initials: ML
authors.lastname: Reeves
authors.affiliation: Department of Medical Physics and Clinical Engineering, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
authors.forename: Jamie
authors.initials: J
authors.lastname: Healey
authors.affiliation: Department of Medical Physics and Clinical Engineering, Royal Hallamshire Hospital, Sheffield S10 2JF, UK.
authors.forename: Timothy R
authors.initials: TR
authors.lastname: Good
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK; School of Mechanical, Aerospace and Civil Engineering, University of Manchester, Manchester M13 9PL, UK.
authors.forename: Glen
authors.initials: G
authors.lastname: Cooper
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK.
authors.forename: Ning
authors.initials: N
authors.lastname: Sha
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK; Division of Health and Rehabilitation, University of Huddersfield, Huddersfield HD1 3DH, UK.
authors.forename: Sarah
authors.initials: S
authors.lastname: Prenton
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK.
authors.forename: Anmin
authors.initials: A
authors.lastname: Liu
authors.affiliation: Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK.
authors.forename: David
authors.initials: D
authors.lastname: Howard
mesh_terms: D000368:Aged; D004599:Electric Stimulation Therapy / Q000295:instrumentation*; D004566:Electrodes; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D020233:Gait Disorders, Neurologic / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged
keywords: Automated setup; Drop foot; Electrode arrays; Functional electrical stimulation; System design