KITE, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
Institute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.
Disabil Rehabil Assist Technol. 2021 Apr;16(3):241-250. doi: 10.1080/17483107.2019.1668974. Epub 2019 Oct 8.
Functional electrical stimulation (FES), through repetitive training (FES-therapy) or continuous assistance (neuro-prosthesis), can restore motor function after paralysis due to spinal cord injury or stroke. With current technology, patients are often incapable of independently applying FES, thereby limiting its use. Novel FES-garments with embedded stimulation electrodes were developed in collaboration with Myant, Canada, to address this problem. The purpose of this study was to collect the views of future end-users to inform the refinement of the device design and to obtain insights on subsequent commercialization of this rehabilitation and assistive technology.
A qualitative study was undertaken to determine the needs of potential users (patients and clinicians; = 19). Participant took part in interviews or focus groups after a presentation of the garments. An inductive content analysis was used to generate the themes from the data and identify data saturation.
The identified themes and sub-themes were: (1) User Perspectives: users' characteristics (needs, limitations), expected benefits (beliefs), and anticipated problems (fears); (2) Device Design: technical features, usability, and disadvantages of the garment, cables, stimulator, software, and interface; (3) Acquisition Process: organizational procedures (acquisition and adoption steps); and (4) Business Model: financial and strategic aspects to facilitate commercialization and support users.
The insights obtained from end-users and clinicians provide guidelines to optimize the development of novel FES-garments, and strategies for bringing the device to the market. The themes identified can serve to inform other rehabilitation and assistive technology developers with processes and ideas on how to meet these groups' needs.IMPLICATIONS FOR REHABILITATIONParticipants with neurological paralysis have interest and critical views on new rehabilitation and assistive technology, and the repercussions of using new technologies to address their function, health and wellbeing.The FES-garment design presented appeared acceptable to the end-users, pending resolution of certain shortcomings (wiring, operating duration, robustness, easiness to don and doff).End-users and clinicians had specific views regarding the acquisition process of new technologies (training, customization, and follow-up/support), which are important to take into consideration to ensure broad stakeholders uptake.
功能性电刺激(FES)通过重复训练(FES 疗法)或连续辅助(神经假体),可以恢复因脊髓损伤或中风而导致的瘫痪后的运动功能。由于当前技术的限制,患者往往无法独立应用 FES,从而限制了其使用。加拿大 Myant 公司合作开发了一种带有嵌入式刺激电极的新型 FES 服装,以解决这个问题。本研究的目的是收集未来终端用户的意见,为设备设计的改进提供信息,并深入了解这种康复和辅助技术的后续商业化。
采用定性研究方法,确定潜在用户(患者和临床医生;n=19)的需求。在介绍服装后,参与者参加了访谈或焦点小组。采用归纳内容分析法从数据中生成主题,并确定数据饱和情况。
确定的主题和子主题包括:(1)用户视角:用户的特点(需求、限制)、预期收益(信念)和预期问题(恐惧);(2)设备设计:技术特点、可用性以及服装、电缆、刺激器、软件和界面的缺点;(3)获取流程:组织程序(获取和采用步骤);(4)商业模式:为促进商业化和支持用户提供财务和战略方面的考虑。
从终端用户和临床医生那里获得的见解为优化新型 FES 服装的开发提供了指导,并为该设备推向市场提供了策略。确定的主题可以为其他康复和辅助技术的开发者提供关于如何满足这些群体需求的流程和思路的信息。
患有神经瘫痪的参与者对新的康复和辅助技术有兴趣和批判性意见,以及使用新技术来解决他们的功能、健康和幸福感所带来的影响。
终端用户对所展示的 FES 服装设计表示认可,前提是解决某些缺点(布线、运行时间、耐用性、穿着和脱卸的简便性)。
终端用户和临床医生对新技术的获取过程(培训、定制和后续支持)有具体的看法,这对于确保广泛的利益相关者采用是很重要的。