Background: Overground Robot-Assisted Gait Training (o-RAGT) provides intensive gait rehabilitation. This study investigated the efficacy of o-RAGT in subacute stroke subjects, compared to conventional gait training. Methods: A multicenter randomized controlled trial was conducted on 75 subacute stroke subjects (38 in the Experimental Group (EG) and 37 in the Control Group (CG)). Both groups received 15 sessions of gait training (5 sessions/week for 60 min) and daily conventional rehabilitation. The subjects were assessed at the beginning (T1) and end (T2) of the training period with the primary outcome of a 6 Minutes Walking Test (6MWT), the Modified Ashworth Scale of the Affected lower Limb (MAS-AL), the Motricity Index of the Affected lower Limb (MI-AL), the Trunk Control Test (TCT), Functional Ambulation Classification (FAC), a 10 Meters Walking Test (10MWT), the modified Barthel Index (mBI), and the Walking Handicap Scale (WHS). Results: The 6MWT increased in both groups, which was confirmed by both frequentist and Bayesian analyses. Similar outcomes were registered in the MI-AL, 10MWT, mBI, and MAS-AL. The FAC and WHS showed a significant number of subjects improving in functional and community ambulation in both groups at T2. Conclusions: The clinical effects of o-RAGT were similar to conventional gait training in subacute stroke subjects. The results obtained in this study are encouraging and suggest future clinical trials on the topic.

中文翻译：

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使用地上动力外骨骼进行步态恢复：对亚急性中风受试者的随机对照试验


背景：地面机器人辅助步态训练（o-RAGT）提供强化步态康复。本研究调查了与传统步态训练相比，o-RAGT 对亚急性中风受试者的疗效。方法：对 75 名亚急性卒中受试者（实验组 (EG) 38 名，对照组 (CG) 37 名）进行多中心随机对照试验。两组均接受 15 次步态训练（每周 5 次，每次 60 分钟）和每日常规康复训练。在训练期开始 (T1) 和结束 (T2) 时对受试者进行评估，主要结果为 6 分钟步行测试 (6MWT)、受影响下肢改良 Ashworth 量表 (MAS-AL)、运动度受影响下肢指数 (MI-AL)、躯干控制测试 (TCT)、功能性步行分类 (FAC)、10 米步行测试 (10MWT)、改良巴塞尔指数 (mBI) 和步行障碍量表 (世界卫生大会）。结果：两组的 6MWT 均有所增加，频率学分析和贝叶斯分析都证实了这一点。 MI-AL、10MWT、mBI 和 MAS-AL 中也出现了类似的结果。 FAC 和 WHS 显示，在 T2 时，两组中大量受试者的功能和社区行走能力均得到改善。结论：o-RAGT 对亚急性脑卒中受试者的临床效果与常规步态训练相似。这项研究获得的结果令人鼓舞，并预示着未来该主题的临床试验。