Lazzarini Stefano G, Mosconi Bianca, Cordani Claudio, Arienti Chiara, Cecchi Francesca
Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
IRCCS Fondazione Don Carlo Gnocchi, Via A. Capecelatro 66, 20148, Milan, Italy.
J Neurol. 2024 Dec 12;272(1):22. doi: 10.1007/s00415-024-12798-z.
This work aimed to update and summarize the existing evidence on the effectiveness of robot-assisted training (RAT) in adults with Parkinson's disease (PD).
We conducted a systematic review with meta-analysis, reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PROSPERO CRD42022371124). Seven databases and two trial registries were searched for randomized-controlled trials (RCTs) addressing RAT alone or in addition to other treatments in adults with PD up to January 2024. Primary outcomes were disease-specific motor impairment, balance, mobility, freezing of gait, falls, number of people who fell at least once, and adverse events. Meta-analysis using a random-effects model was performed. Risk of bias (RoB) and certainty of the evidence for the primary outcomes were assessed using the Cochrane RoB Tool and the Grades of Recommendation Assessment, Development, and Evaluation (GRADE) approach, respectively.
Fifteen RCTs (629 randomized adults with PD) were included. Our results show that the evidence is very uncertain about the effectiveness of any kind of RAT, either focused on gait, balance or upper limb impairment, compared to any comparator (treadmill training, overground gait training, exercises without the exoskeleton, conventional physical therapy, balance training, and no treatment), mainly because of RoB, inconsistency in individual studies results, and very limited number (less than 200) of participants considered in each comparison.
In light of the aforementioned very low certainty evidence, clinical considerations should be drawn very carefully. High-quality studies are thus highly needed to investigate potential benefits, risks, and cost/benefit ratio of RAT in adults with PD.
本研究旨在更新和总结关于机器人辅助训练（RAT）对帕金森病（PD）成人患者有效性的现有证据。
我们按照系统评价和Meta分析的首选报告项目（PRISMA）指南（PROSPERO CRD42022371124）进行了一项系统评价和Meta分析。检索了七个数据库和两个试验注册库，以查找截至2024年1月针对PD成人患者单独进行RAT或与其他治疗联合进行RAT的随机对照试验（RCT）。主要结局包括疾病特异性运动障碍、平衡、活动能力、步态冻结、跌倒、至少跌倒一次的人数以及不良事件。采用随机效应模型进行Meta分析。分别使用Cochrane偏倚风险工具和推荐分级评估、制定与评价（GRADE）方法评估主要结局的偏倚风险（RoB）和证据的确定性。
纳入了15项RCT（629名随机分组的PD成人患者）。我们的结果表明，与任何对照措施（跑步机训练、地面步态训练、无外骨骼的运动、传统物理治疗、平衡训练和不治疗）相比，关于任何类型的RAT（无论是针对步态、平衡还是上肢损伤）的有效性，证据都非常不确定，主要原因是存在偏倚风险、各研究结果不一致以及每次比较中纳入的参与者数量非常有限（少于200人）。
鉴于上述证据确定性极低，临床决策应非常谨慎。因此，迫切需要高质量的研究来调查RAT对PD成人患者的潜在益处、风险和成本效益比。
