Kenney Laurence P, Heller Ben W, Barker Anthony T, Reeves Mark L, Healey Jamie, Good Timothy R, Cooper Glen, Sha Ning, Prenton Sarah, Liu Anmin, Howard David
Centre for Health Sciences Research, University of Salford, Salford M6 6PU, UK.
Centre for Sports Engineering Research, Sheffield Hallam University, Sheffield S1 1WB, UK.
Med Eng Phys. 2016 Nov;38(11):1159-1165. doi: 10.1016/j.medengphy.2016.08.005. Epub 2016 Sep 14.
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.
功能性电刺激已被证明是一种纠正中枢神经源性足下垂的安全有效的方法。目前基于表面的设备通常由一个单通道刺激器、一个用于确定步态阶段的传感器和一个袖带组成，阳极和阴极安装在袖带内。袖带式电极设计降低了电极放置出现大误差的可能性，但用户在每次佩戴系统时仍需完全负责选择正确的刺激水平。研究人员已经研究了实现设置和/或使用自动化的不同方法，包括最近基于迭代学习技术的有前景的工作。本文报道了一种用于纠正足下垂的基于电极阵列的功能性电刺激系统ShefStim的设计和临床评估。本文回顾了从基于概念验证实验室的研究开始的设计过程，包括阵列几何形状和界面层的建模以及阵列搜索算法的开发。最后，本文总结了两项涉及足下垂患者的临床研究。结果表明，具有自动设置功能的ShefStim系统产生的结果与传统系统的临床医生设置相当。此外，最终研究表明患者可以在没有临床监督的情况下使用该系统。在无人监督使用时，设置时间为14分钟（自动搜索9分钟加上穿戴设备5分钟），不过对设计进行相对较小的更改后，这个时间可以显著缩短。
