Unit of Neurorehabilitation, Department of Neuroscience, Biomedicine, and Movement Sciences, University Hospital of Verona, University of Verona, Verona, Italy -
Department of Neuroscience, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
Eur J Phys Rehabil Med. 2021 Oct;57(5):831-840. doi: 10.23736/S1973-9087.21.06922-7. Epub 2021 May 27.
The rapid development of electromechanical and robotic devices has profoundly influenced neurorehabilitation. Growth in the scientific and technological aspects thereof is crucial for increasing the number of newly developed devices, and clinicians have welcomed such growth with enthusiasm. Nevertheless, improving the standard for the reporting clinical, technical, and normative aspects of such electromechanical and robotic devices remains an unmet need in neurorehabilitation. Accordingly, this study aimed to analyze the existing literature on electromechanical and robotic devices used in neurorehabilitation, considering the current clinical, technical, and regulatory classification systems.
Within the CICERONE Consensus Conference framework, studies on electromechanical and robotic devices used for upper- and lower-limb rehabilitation in persons with neurological disabilities in adulthood and childhood were reviewed. We have conducted a literature search using the following databases: MEDLINE, Cochrane Library, PeDro, Institute of Electrical and Electronics Engineers, Science Direct, and Google Scholar. Clinical, technical, and regulatory classification systems were applied to collect information on the electromechanical and robotic devices. The study designs and populations were investigated.
Overall, 316 studies were included in the analysis. More than half (52%) of the studies were randomised controlled trials (RCTs). The population investigated the most suffered from strokes, followed by spinal cord injuries, multiple sclerosis, cerebral palsy, and traumatic brain injuries. In total, 100 devices were described; of these, 19% were certified with the CE mark. Overall, the main type of device was an exoskeleton. However, end-effector devices were primarily used for the upper limbs, whereas exoskeletons were used for the lower limbs (for both children and adults).
The current literature on robotic neurorehabilitation lacks detailed information regarding the technical characteristics of the devices used. This affects the understanding of the possible mechanisms underlying recovery. Unfortunately, many electromechanical and robotic devices are not provided with CE marks, strongly hindering the research on the clinical outcomes of rehabilitation treatments based on these devices. A more significant effort is needed to improve the description of the robotic devices used in neurorehabilitation in terms of the technical and functional details, along with high-quality RCT studies.
机电和机器人设备的快速发展深刻影响了神经康复。科学技术方面的发展对于增加新开发设备的数量至关重要，临床医生对此也热情欢迎。然而，提高神经康复中机电和机器人设备的临床、技术和规范方面的报告标准仍然是一个未满足的需求。因此，本研究旨在分析当前用于成人和儿童神经康复的机电和机器人设备的现有文献，同时考虑当前的临床、技术和监管分类系统。
在 CICERONE 共识会议框架内，对成人和儿童神经功能障碍患者使用的上下肢康复机电和机器人设备进行了研究。我们使用以下数据库进行了文献检索：MEDLINE、Cochrane 图书馆、PeDro、电气和电子工程师协会、Science Direct 和 Google Scholar。应用临床、技术和监管分类系统收集机电和机器人设备的信息。研究设计和人群进行了调查。
共有 316 项研究纳入分析。超过一半（52%）的研究为随机对照试验（RCT）。研究人群中最常见的是中风患者，其次是脊髓损伤、多发性硬化症、脑瘫和创伤性脑损伤患者。总共描述了 100 种设备；其中，19%获得了 CE 标志认证。总体而言，主要的设备类型是外骨骼。然而，末端效应器设备主要用于上肢，而外骨骼则用于下肢（儿童和成人）。
当前关于机器人神经康复的文献缺乏对所使用设备技术特征的详细信息。这影响了对康复潜在机制的理解。不幸的是，许多机电和机器人设备没有 CE 标志，严重阻碍了基于这些设备的康复治疗临床结果的研究。需要付出更大的努力，以提高神经康复中使用的机器人设备在技术和功能细节方面的描述，并开展高质量的 RCT 研究。
