Mehrholz Jan, Kugler Joachim, Pohl Marcus, Elsner Bernhard
Department of Public Health, Dresden Medical School, Technical University Dresden, Dresden, Germany.
Clinic for Neurological-Neurosurgical Rehabilitation, Vamed Klinik Schloss Pulsnitz, Pulsnitz, Germany.
Cochrane Database Syst Rev. 2025 May 14;5(5):CD006185. doi: 10.1002/14651858.CD006185.pub6.
Walking difficulties are common after a stroke. During rehabilitation, electromechanical and robotic gait-training devices can help improve walking. As the evidence and certainty of the evidence may have changed since our last update in 2020, we aimed to update the scientific evidence on the benefits and acceptability of these technologies to ensure they remain a viable option for stroke rehabilitation.
Primary • To determine whether electromechanical- and robot-assisted gait training versus physiotherapy (or usual care) improves walking in adults after stroke. Secondary • To determine whether electromechanical- and robot-assisted gait training versus physiotherapy (or usual care) after stroke improves walking velocity, walking capacity, acceptability, and death from all causes until the end of the intervention phase.
We searched CENTRAL, MEDLINE, Embase, and seven other databases. We handsearched relevant conference proceedings, searched trials and research registers, checked reference lists, and contacted trial authors to identify further published, unpublished, and ongoing trials. The date of the latest search was December 2023.
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 robot-assisted gait training versus physiotherapy (or usual care).
Our critical outcome was the ability to walk independently, measured with the Functional Ambulation Category (FAC). An FAC score of 4 or 5 indicated independent walking over a 15-metre surface, irrespective of aids used, such as a cane. An FAC score less than 4 indicates dependency in walking (supervision or assistance, or both, must be given in performing walking). Important outcomes included walking velocity and capacity, as well as dropouts.
We used Cochrane's RoB 1 tool.
Two review authors independently selected trials for inclusion, assessed methodological quality and risk of bias, and extracted data. We used random-effects models for the meta-analysis. We assessed the certainty of evidence using the GRADE approach.
We included 101 studies (39 new studies plus 62 studies from previous versions) with a total of 4224 participants after stroke in our review update.
Electromechanical-assisted gait training in combination with physiotherapy probably increases the odds of participants becoming independent in walking (odds ratio (OR) 1.65, 95% confidence interval (CI) 1.21 to 2.25; P = 0.001; I² = 31%; 51 studies, 2148 participants; moderate-certainty evidence); probably does not increase mean walking velocity (mean difference (MD) 0.05 m/s, 95% CI 0.02 to 0.08; P < 0.001; I² = 58%; 73 studies, 3043 participants; moderate-certainty evidence); and does not increase mean walking capacity (MD 11 metres walked in 6 minutes, 95% CI 1.8 to 20.3; P = 0.02; I² = 43%; 42 studies, 1966 participants; high-certainty evidence). Electromechanical-assisted gait training does not increase or decrease the risk of loss to the study during the intervention or the risk of death from all causes (high-certainty evidence). At follow-up after study end, electromechanical-assisted gait training in combination with physiotherapy may not increase the odds of participants becoming independent in walking (OR 1.64, 95% CI 0.77 to 3.48; P = 0.20; I² = 69%; 8 studies, 569 participants; low-certainty evidence), and probably does not increase mean walking velocity (MD 0.05 m/s, 95% CI -0.03 to 0.13; P = 0.22; I² = 66%; 17 studies, 857 participants; moderate-certainty evidence) or mean walking capacity (MD 9.6 metres walked in 6 minutes, 95% CI -14.6 to 33.7; P = 0.44; I² = 53%; 15 studies, 736 participants; moderate-certainty evidence). Our results must be interpreted with caution because (1) some trials investigated people who were independent in walking at the start of the study; and (2) there was variation between trials with respect to the devices used and duration and frequency of treatment.
AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that people who receive electromechanical-assisted gait training in combination with physiotherapy after stroke are probably more likely to achieve independent walking than people who receive gait training without these devices.We concluded that nine patients need to be treated to prevent one dependency in walking. Further research should consist of large, definitive pragmatic phase 3 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. Future trials should consider time poststroke in their trial design.
This Cochrane review had no dedicated funding.
Protocol (2006): doi:10.1002/14651858.CD006185 Original review (2007): doi:10.1002/14651858.CD006185.pub2 Review update (2013): doi:10.1002/14651858.CD006185.pub3 Review update (2017): doi:10.1002/14651858.CD006185.pub4 Review update (2020): doi:10.1002/14651858.CD006185.pub5.
中风后行走困难很常见。在康复过程中，机电和机器人步态训练设备有助于改善行走能力。自我们2020年上次更新以来，证据及证据的确定性可能已发生变化，我们旨在更新有关这些技术的益处和可接受性的科学证据，以确保它们仍然是中风康复的可行选择。
主要目的•确定机电辅助和机器人辅助步态训练与物理治疗（或常规护理）相比，是否能改善中风后成年人的行走能力。次要目的•确定中风后机电辅助和机器人辅助步态训练与物理治疗（或常规护理）相比，在干预阶段结束前是否能提高行走速度、行走能力、可接受性并降低全因死亡率。
我们检索了Cochrane系统评价数据库、MEDLINE、Embase以及其他七个数据库。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，并联系试验作者以识别更多已发表、未发表和正在进行的试验。最新检索日期为2023年12月。
我们纳入了所有针对18岁以上、在任何阶段、任何环境下被诊断为任何严重程度中风的人群的随机对照试验和随机对照交叉试验，评估机电辅助和机器人辅助步态训练与物理治疗（或常规护理）的效果。
我们的关键结局指标是独立行走能力，采用功能性步行分类（FAC）进行测量。FAC评分为4或5表示在15米的路面上能够独立行走，无论是否使用辅助工具，如拐杖。FAC评分低于4表示行走依赖（在行走时必须给予监督或协助，或两者都需要）。重要结局指标包括行走速度和能力，以及失访情况。
我们使用Cochrane的RoB 1工具。
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。我们使用随机效应模型进行荟萃分析。我们使用GRADE方法评估证据的确定性。
在本次综述更新中，我们纳入了101项研究（39项新研究加上62项来自 previous版本的研究），共有4224名中风后参与者。
机电辅助步态训练联合物理治疗可能会增加参与者独立行走的几率（优势比（OR）1.65，95%置信区间（CI）1.21至2.25；P = 0.001；I² = 31%；51项研究，2148名参与者；中等确定性证据）；可能不会增加平均行走速度（平均差（MD）0.05 m/s，95% CI 0.02至0.08；P < 0.001；I² = 58%；73项研究，3043名参与者；中等确定性证据）；并且不会增加平均行走能力（6分钟内行走的平均距离MD为11米，95% CI 1.8至20.3；P = 0.02；I² = 43%；42项研究，1966名参与者；高确定性证据）。机电辅助步态训练不会增加或降低干预期间失访的风险或全因死亡风险（高确定性证据）。在研究结束后的随访中，机电辅助步态训练联合物理治疗可能不会增加参与者独立行走的几率（OR 1.64，95% CI 0.77至3.48；P = 0.20；I² = 69%；8项研究，569名参与者；低确定性证据），并且可能不会增加平均行走速度（MD 0.05 m/s，95% CI -0.03至0.13；P = 0.22；I² = 66%；17项研究，857名参与者；中等确定性证据）或平均行走能力（6分钟内行走的平均距离MD为9.6米，95% CI -14.6至33.7；P = 0.44；I² = 53%；各项研究，736名参与者；中等确定性证据）。我们的结果必须谨慎解释，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）不同试验在使用的设备、治疗持续时间和频率方面存在差异。
中等确定性证据表明，中风后接受机电辅助步态训练联合物理治疗的人比接受无这些设备的步态训练的人更有可能实现独立行走。我们得出结论，需要治疗9名患者以预防1例行走依赖。进一步的研究应包括大型、确定性的实用3期试验，以解决有关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。未来的试验应在试验设计中考虑中风后的时间。
本Cochrane综述没有专门的资金。
方案（2006）：doi:10.1002/14651858.CD006185 原始综述（2007）：doi:10.1002/1465!858.CD006185.pub2 综述更新（2013）：doi:10.1002/14651858.CD006185.pub3 综述更新（2017）：doi:10.1002/14651858.CD006185.pub4 综述更新（2020）：doi:10.1002/14651858.CD006185.pub5 。
