I.R.C.C.S. Santa Lucia Foundation (FSL), Via Ardeatina, 306, 00179, Rome, Italy.
J Neuroeng Rehabil. 2022 Mar 15;19(1):27. doi: 10.1186/s12984-022-01003-9.
Overground powered lower limb exoskeletons (EXOs) have proven to be valid devices in gait rehabilitation in individuals with spinal cord injury (SCI). Although several articles have reported the effects of EXOs in these individuals, the few reviews available focused on specific domains, mainly walking. The aim of this systematic review is to provide a general overview of the effects of commercial EXOs (i.e. not EXOs used in military and industry applications) for medical purposes in individuals with SCI. This systematic review was conducted following the PRISMA guidelines and it referred to MED-LINE, EMBASE, SCOPUS, Web of Science and Cochrane library databases. The studies included were Randomized Clinical Trials (RCTs) and non-RCT based on EXOs intervention on individuals with SCI. Out of 1296 studies screened, 41 met inclusion criteria. Among all the EXO studies, the Ekso device was the most discussed, followed by ReWalk, Indego, HAL and Rex devices. Since 14 different domains were considered, the outcome measures were heterogeneous. The most investigated domain was walking, followed by cardiorespiratory/metabolic responses, spasticity, balance, quality of life, human-robot interaction, robot data, bowel functionality, strength, daily living activity, neurophysiology, sensory function, bladder functionality and body composition/bone density domains. There were no reports of negative effects due to EXOs trainings and most of the significant positive effects were noted in the walking domain for Ekso, ReWalk, HAL and Indego devices. Ekso studies reported significant effects due to training in almost all domains, while this was not the case with the Rex device. Not a single study carried out on sensory functions or bladder functionality reached significance for any EXO. It is not possible to draw general conclusions about the effects of EXOs usage due to the lack of high-quality studies as addressed by the Downs and Black tool, the heterogeneity of the outcome measures, of the protocols and of the SCI epidemiological/neurological features. However, the strengths and weaknesses of EXOs are starting to be defined, even considering the different types of adverse events that EXO training brought about. EXO training showed to bring significant improvements over time, but whether its effectiveness is greater or less than conventional therapy or other treatments is still mostly unknown. High-quality RCTs are necessary to better define the pros and cons of the EXOs available today. Studies of this kind could help clinicians to better choose the appropriate training for individuals with SCI.
地面式动力下肢外骨骼（EXO）已被证明是脊髓损伤（SCI）患者步态康复的有效装置。尽管有几篇文章报道了 EXO 在这些患者中的作用，但现有的少数综述主要集中在特定领域，主要是行走。本系统综述的目的是提供商业 EXO（即非军事和工业应用中使用的 EXO）在 SCI 患者中的医疗用途的综合概述。本系统综述遵循 PRISMA 指南，并参考了 MED-LINE、EMBASE、SCOPUS、Web of Science 和 Cochrane 图书馆数据库。纳入的研究是基于 EXO 干预的 SCI 患者的随机临床试验（RCT）和非 RCT。在筛选出的 1296 项研究中，有 41 项符合纳入标准。在所有 EXO 研究中，Ekso 设备讨论最多，其次是 ReWalk、Indego、HAL 和 Rex 设备。由于考虑了 14 个不同的领域，因此结果测量指标存在异质性。研究最多的领域是行走，其次是心肺/代谢反应、痉挛、平衡、生活质量、人机交互、机器人数据、肠道功能、力量、日常生活活动、神经生理学、感觉功能、膀胱功能和身体成分/骨密度领域。没有报道 EXO 训练有负面效果，并且大多数显著的积极效果都在 Ekso、ReWalk、HAL 和 Indego 设备的行走领域中观察到。Ekso 研究报告称，由于训练，几乎所有领域都有显著效果，而 Rex 设备则不然。没有一项针对感觉功能或膀胱功能的研究对任何 EXO 达到显著水平。由于 Downs 和 Black 工具所指出的高质量研究的缺乏、结果测量的异质性、方案的异质性以及 SCI 流行病学/神经学特征的异质性，不可能就 EXO 使用的效果得出一般结论。然而，即使考虑到 EXO 训练带来的不同类型的不良事件，EXO 的优缺点也开始得到定义。EXO 训练随着时间的推移显示出显著的改善，但它的有效性是否大于或小于传统疗法或其他治疗方法，在很大程度上仍然未知。高质量的 RCT 对于更好地定义当今可用的 EXO 的优缺点是必要的。此类研究可以帮助临床医生更好地为 SCI 患者选择适当的训练。
