Contreras-Vidal Jose L, A Bhagat Nikunj, Brantley Justin, Cruz-Garza Jesus G, He Yongtian, Manley Quinn, Nakagome Sho, Nathan Kevin, Tan Su H, Zhu Fangshi, Pons Jose L
Laboratory for Non-invasive Brain-Machine Interface Systems, Department of Electrical Engineering, University of Houston, Houston, TX 77204, USA.
J Neural Eng. 2016 Jun;13(3):031001. doi: 10.1088/1741-2560/13/3/031001. Epub 2016 Apr 11.
Powered exoskeletons promise to increase the quality of life of people with lower-body paralysis or weakened legs by assisting or restoring legged mobility while providing health benefits across multiple physiological systems. Here, a systematic review of the literature on powered exoskeletons addressed critical questions: What is the current evidence of clinical efficacy for lower-limb powered exoskeletons? What are the benefits and risks for individuals with spinal cord injury (SCI)? What are the levels of injury considered in such studies? What are their outcome measures? What are the opportunities for the next generation exoskeletons?
A systematic search of online databases was performed to identify clinical trials and safety or efficacy studies with lower-limb powered exoskeletons for individuals with SCI. Twenty-two studies with eight powered exoskeletons thus selected, were analyzed based on the protocol design, subject demographics, study duration, and primary/secondary outcome measures for assessing exoskeleton's performance in SCI subjects.
Findings show that the level of injury varies across studies, with T10 injuries being represented in 45.4% of the studies. A categorical breakdown of outcome measures revealed 63% of these measures were gait and ambulation related, followed by energy expenditure (16%), physiological improvements (13%), and usability and comfort (8%). Moreover, outcome measures varied across studies, and none had measures spanning every category, making comparisons difficult.
This review of the literature shows that a majority of current studies focus on thoracic level injury as well as there is an emphasis on ambulatory-related primary outcome measures. Future research should: 1) develop criteria for optimal selection and training of patients most likely to benefit from this technology, 2) design multimodal gait intention detection systems that engage and empower the user, 3) develop real-time monitoring and diagnostic capabilities, and 4) adopt comprehensive metrics for assessing safety, benefits, and usability.
动力外骨骼有望通过辅助或恢复腿部移动能力来提高下半身瘫痪或腿部无力者的生活质量，同时为多个生理系统带来健康益处。在此，对动力外骨骼相关文献进行的系统综述解决了以下关键问题：下肢动力外骨骼临床疗效的现有证据是什么？脊髓损伤（SCI）患者的益处和风险有哪些？此类研究中考虑的损伤水平有哪些？其结果指标是什么？下一代外骨骼有哪些机遇？
对在线数据库进行系统检索，以识别针对SCI患者的下肢动力外骨骼的临床试验以及安全性或疗效研究。基于方案设计、受试者人口统计学特征、研究持续时间以及评估外骨骼在SCI受试者中性能的主要/次要结果指标，对由此选出的涉及八种动力外骨骼的22项研究进行了分析。
研究结果表明，不同研究中的损伤水平各不相同，45.4%的研究涉及T10损伤。结果指标的分类细目显示，这些指标中有63%与步态和行走相关，其次是能量消耗（16%）、生理改善（13%）以及可用性和舒适度（8%）。此外，不同研究的结果指标各不相同，且没有一项研究的指标涵盖所有类别，这使得比较变得困难。
该文献综述表明，当前大多数研究聚焦于胸段损伤水平，并且强调与行走相关的主要结果指标。未来研究应：1）制定标准，以优化选择最有可能从该技术中受益的患者并对其进行培训；2）设计多模式步态意图检测系统，让用户参与并增强其能力；3）开发实时监测和诊断能力；4）采用综合指标来评估安全性、益处和可用性。
