Feasibility Study of a Take-Home Array-Based Functional Electrical Stimulation System With Automated Setup for Current Functional Electrical Stimulation Users With Foot-Drop

Prenton, Sarah; Kenney, Laurence; Stapleton, Claire; Cooper, Glen M.; Reeves, Mark L.; Heller, Ben; Sobuh, Mohammad; Barker, Anthony T.; Healey, J.; Good, Tim; Thies, Sibylle B.; Howard, David; Williamson, Tracey

doi:10.1016/j.apmr.2014.04.027

Cited by 22 publications

(26 citation statements)

References 34 publications

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“…In a recent publication, Kenney et al described a ShefStim device [15, 26] array-based FES system for the correction of foot drop that comprises a three-phase search algorithm for finding an appropriate candidate out of 25 stimulation patterns within a multi-pad array. Prenton et al tested the automatic algorithm for stimulation pattern selection described by Kenney et al [15] for unsupervised use by individuals with foot drop [27]. …”

Section: Introductionmentioning

confidence: 99%

A decision support system for electrode shaping in multi-pad FES foot drop correction

Malešević

Dujović

Savić

et al. 2017

J NeuroEngineering Rehabil

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BackgroundFunctional electrical stimulation (FES) can be applied as an assistive and therapeutic aid in the rehabilitation of foot drop. Transcutaneous multi-pad electrodes can increase the selectivity of stimulation; however, shaping the stimulation electrode becomes increasingly complex with an increasing number of possible stimulation sites. We described and tested a novel decision support system (DSS) to facilitate the process of multi-pad stimulation electrode shaping. The DSS is part of a system for drop foot treatment that comprises a custom-designed multi-pad electrode, an electrical stimulator, and an inertial measurement unit.MethodsThe system was tested in ten stroke survivors (3–96 months post stroke) with foot drop over 20 daily sessions. The DSS output suggested stimulation pads and parameters based on muscle twitch responses to short stimulus trains. The DSS ranked combinations of pads and current amplitudes based on a novel measurement of the quality of the induced movement and classified them based on the movement direction (dorsiflexion, plantar flexion, eversion and inversion) of the paretic foot. The efficacy of the DSS in providing satisfactory pad-current amplitude choices for shaping the stimulation electrode was evaluated by trained clinicians. The range of paretic foot motion was used as a quality indicator for the chosen patterns.ResultsThe results suggest that the DSS output was highly effective in creating optimized FES patterns. The position and number of pads included showed pronounced inter-patient and inter-session variability; however, zones for inducing dorsiflexion and plantar flexion within the multi-pad electrode were clearly separated. The range of motion achieved with FES was significantly greater than the corresponding active range of motion (p < 0.05) during the first three weeks of therapy.ConclusionsThe proposed DSS in combination with a custom multi-pad electrode design covering the branches of peroneal and tibial nerves proved to be an effective tool for producing both the dorsiflexion and plantar flexion of a paretic foot. The results support the use of multi-pad electrode technology in combination with automatic electrode shaping algorithms for the rehabilitation of foot drop.Trial registrationThis study was registered at the Current Controlled Trials website with ClinicalTrials.gov ID NCT02729636 on March 29, 2016.

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Section: Introductionmentioning

confidence: 99%

A decision support system for electrode shaping in multi-pad FES foot drop correction

Malešević

Dujović

Savić

et al. 2017

J NeuroEngineering Rehabil

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“…Other minor product development issues remain, including the development of an improved garment to house the stimulator on the leg and minor improvements to the firmware, all of which may be easily resolved. We believe that these improvements would lead to a significant reduction in setup time, as recorded in our final (unsupervised) study [7].…”

Section: Discussionmentioning

confidence: 99%

“…By far the most significant of these is that sweat ingress to the hydrogel electrode interface layer leads to a significant drop in its resistivity and an inevitable decay in focality and stimulation efficiency with wear time [30].These effects limit use of a given array to around one day of continuous wear. In the final study of ShefStim [7] we were able to provide participants with sufficient arrays to use a fresh hydrogel layer each day. However, the cost of such an approach is high and not a realistic solution in clinical practice.…”

Section: Discussionmentioning

confidence: 99%

“…The reader is referred to [7] for the experimental protocol and full results. Log data showed that all subjects were able to setup the stimulator outside of the laboratory environment without technical support.…”

Section: First Take-home Study Of Shefstimmentioning

confidence: 99%

“…Such an approach greatly 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. Interestingly, despite improvements in both stimulator designs and patient education, two recent studies demonstrated that when patients set up their stimulators without clinician support, the resultant foot response is often less than optimal [6,7].…”

Section: Introductionmentioning

confidence: 99%

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

Kenney

Heller

Barker

et al. 2016

Medical Engineering & Physics

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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 14 minutes (9 minutes for automated search plus 5 minutes for donning the equipment), although this figure could be reduced significantly with relatively minor changes to the design.

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Motion control of the rabbit ankle joint with a flat interface nerve electrode

Park

Durand

2015

Muscle and Nerve

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INTRODUCTION A flat interface nerve electrode (FINE) has been shown to improve fascicular and subfascicular selectivity. A recently developed novel control algorithm for FINE was applied to motion control of the rabbit ankle. METHODS A 14-contact FINE was placed on the rabbit sciatic nerve (n=8), and ankle joint motion was controlled for sinusoidal trajectories and filtered random trajectories. To this end, a real time controller was implemented with a multiple-channel current stimulus isolator. RESULTS The performance test results showed good tracking performance of rabbit ankle joint motion for filtered random trajectories and sinusoidal trajectories (0.5Hz and 1.0Hz) with less than 10% average root-mean-square (RMS) tracking error, while the average range of ankle joint motion was between −20.0° ± 9.3° and 18.1° ± 8.8°. CONCLUSIONS The proposed control algorithm enables the use of a multiple contact nerve electrode for motion trajectory tracking control of musculoskeletal systems.

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Feasibility Study of a Take-Home Array-Based Functional Electrical Stimulation System With Automated Setup for Current Functional Electrical Stimulation Users With Foot-Drop

Cited by 22 publications

References 34 publications

A decision support system for electrode shaping in multi-pad FES foot drop correction

A decision support system for electrode shaping in multi-pad FES foot drop correction

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

Motion control of the rabbit ankle joint with a flat interface nerve electrode

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