Mehrholz Jan, Thomas Simone, Werner Cordula, Kugler Joachim, Pohl Marcus, Elsner Bernhard
Department of Public Health, Dresden Medical School, Technical University Dresden, Fetscherstr. 74, Dresden, Germany, 01307.
Wissenschaftliches Institut, Klinik Bavaria Kreischa, Kreischa, Germany, 01731.
Cochrane Database Syst Rev. 2017 May 10;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub4.
Electromechanical- and robotic-assisted gait-training devices are used in rehabilitation and might help to improve walking after stroke. This is an update of a Cochrane Review first published in 2007.
To investigate the effects of automated electromechanical- and robotic-assisted gait-training devices for improving walking after stroke.
We searched the Cochrane Stroke Group Trials Register (last searched 9 August 2016), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 8), MEDLINE in Ovid (1950 to 15 August 2016), Embase (1980 to 15 August 2016), CINAHL (1982 to 15 August 2016), AMED (1985 to 15 August 2016), Web of Science (1899 to 16 August 2016), SPORTDiscus (1949 to 15 September 2012), the Physiotherapy Evidence Database (PEDro) (searched 16 August 2016), and the engineering databases COMPENDEX (1972 to 16 November 2012) and Inspec (1969 to 26 August 2016). We handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted authors in an effort to identify further published, unpublished, and ongoing trials.
We included all randomised controlled trials and randomised controlled cross-over trials in people over the age of 18 years diagnosed with stroke of any severity, at any stage, in any setting, evaluating electromechanical- and robotic-assisted gait training versus normal care.
Two review authors independently selected trials for inclusion, assessed methodological quality and risk of bias, and extracted the data. The primary outcome was the proportion of participants walking independently at follow-up.
We included 36 trials involving 1472 participants in this review update. Electromechanical-assisted gait training in combination with physiotherapy increased the odds of participants becoming independent in walking (odds ratio (random effects) 1.94, 95% confidence interval (CI) 1.39 to 2.71; P < 0.001; I² = 8%; moderate-quality evidence) but did not significantly increase walking velocity (mean difference (MD) 0.04 m/s, 95% CI 0.00 to 0.09; P = 0.08; I² = 65%; low-quality evidence) or walking capacity (MD 5.84 metres walked in 6 minutes, 95% CI -16.73 to 28.40; P = 0.61; I² = 53%; very low-quality evidence). The results must be interpreted with caution because 1) some trials investigated people who were independent in walking at the start of the study, 2) we found variations between the trials with respect to devices used and duration and frequency of treatment, and 3) some trials included devices with functional electrical stimulation. Our planned subgroup analysis suggested that people in the acute phase may benefit, but people in the chronic phase may not benefit from electromechanical-assisted gait training. Post hoc analysis showed that people who are non-ambulatory at intervention onset may benefit, but ambulatory people may not benefit from this type of training. Post hoc analysis showed no differences between the types of devices used in studies regarding ability to walk, but significant differences were found between devices in terms of walking velocity.
AUTHORS' CONCLUSIONS: People who receive electromechanical-assisted gait training in combination with physiotherapy after stroke are more likely to achieve independent walking than people who receive gait training without these devices. We concluded that seven patients need to be treated to prevent one dependency in walking. Specifically, people in the first three months after stroke and those who are not able to walk seem to benefit most from this type of intervention. The role of the type of device is still not clear. Further research should consist of large definitive pragmatic phase III trials undertaken to address specific questions about the most effective frequency and duration of electromechanical-assisted gait training as well as how long any benefit may last.
机电辅助和机器人辅助步态训练设备用于康复治疗,可能有助于改善中风后的行走能力。这是Cochrane系统评价的更新版,该评价首次发表于2007年。
研究自动化机电辅助和机器人辅助步态训练设备对改善中风后行走能力的效果。
我们检索了Cochrane中风组试验注册库(最后检索时间为2016年8月9日)、Cochrane对照试验中心注册库(CENTRAL)(Cochrane图书馆2016年第8期)、Ovid平台的MEDLINE(1950年至2016年8月15日)、Embase(1980年至2016年8月15日)、CINAHL(1982年至2016年8月15日)、AMED(1985年至2016年8月15日)、科学引文索引(1899年至2016年8月16日)、SPORTDiscus(1949年至2012年9月15日)、物理治疗证据数据库(PEDro)(2016年8月16日检索),以及工程数据库COMPENDEX(1972年至2012年11月16日)和Inspec(1969年至2016年8月26日)。我们手工检索了相关会议论文集,检索了试验和研究注册库,检查了参考文献列表,并与作者联系,以识别更多已发表、未发表和正在进行的试验。
我们纳入了所有针对18岁以上、患有任何严重程度中风、处于任何阶段、在任何环境下诊断的患者的随机对照试验和随机对照交叉试验,比较机电辅助和机器人辅助步态训练与常规护理。
两位综述作者独立选择纳入试验,评估方法学质量和偏倚风险,并提取数据。主要结局是随访时独立行走的参与者比例。
在本次综述更新中,我们纳入了36项试验,涉及1472名参与者。机电辅助步态训练联合物理治疗增加了参与者独立行走的几率(随机效应比值比1.94,95%置信区间(CI)1.39至2.71;P<0.001;I² = 8%;中等质量证据),但未显著提高行走速度(平均差(MD)0.04 m/s,95% CI 0.00至0.09;P = 0.08;I² = 65%;低质量证据)或行走能力(6分钟行走距离MD 5.84米,95% CI -16.73至28.40;P = 0.61;I² = 53%;极低质量证据)。结果必须谨慎解释,因为1)一些试验研究的是在研究开始时能够独立行走的人群,2)我们发现试验之间在使用的设备、治疗持续时间和频率方面存在差异,3)一些试验纳入了带有功能性电刺激的设备。我们计划的亚组分析表明,急性期患者可能受益,但慢性期患者可能无法从机电辅助步态训练中获益。事后分析表明,干预开始时不能行走的患者可能受益,但能行走的患者可能无法从这种类型的训练中获益。事后分析表明,研究中使用的设备类型在行走能力方面无差异,但在行走速度方面设备之间存在显著差异。
中风后接受机电辅助步态训练联合物理治疗的患者比接受无这些设备的步态训练的患者更有可能实现独立行走。我们得出结论,需要治疗7名患者以预防1例行走依赖。具体而言,中风后前三个月的患者以及不能行走的患者似乎从这种类型的干预中获益最大。设备类型的作用仍不明确。进一步的研究应包括大型确定性实用的III期试验,以解决关于机电辅助步态训练最有效频率和持续时间以及任何益处可能持续多久的具体问题。