Virtual reality and arm cycling have been reported as effective treatments for improving upper limb motor recovery in patients with stroke. Intermittent theta burst stimulation (iTBS) can increase ipsilesional cortical excitability, and has been increasingly used in patients with stroke. However, few studies examined the augmented effect of iTBS on neurorehabilitation program. In this study, we investigated the augmented effect of iTBS on virtual reality-based cycling training (VCT) for upper limb function in patients with stroke. In this randomized controlled trial, 23 patients with stroke were recruited. Each patient received either 15 sessions of iTBS or sham stimulation in addition to VCT on the same day. Outcome measures were assessed before and after the intervention. Primary outcome measures for the improvement of upper limb motor function and spasticity were Fugl-Meyer Assessment-Upper Extremity (FMA-UE) and Modified Ashworth Scale Upper-Extremity (MAS-UE). Secondary outcome measures for activity and participation were Action Research Arm Test (ARAT), Nine Hole Peg Test (NHPT), Box and Block Test (BBT) and Motor Activity Log (MAL), and Stroke Impact Scale (SIS). Wilcoxon signed-rank tests were performed to evaluate the effectiveness after the intervention and Mann–Whitney U tests were conducted to compare the therapeutic effects between two groups. At post-treatment, both groups showed significant improvement in FMA-UE and ARAT, while only the iTBS + VCT group demonstrated significant improvement in MAS-UE, BBT, NHPT, MAL and SIS. The Mann–Whitney U tests revealed that the iTBS + VCT group has presented greater improvement than the sham group significantly in MAS-UE, MAL-AOU and SIS. However, there were no significant differences in the changes of the FMA-UE, ARAT, BBT, NHPT and MAL-QOM between groups. Intermittent TBS showed augmented efficacy on VCT for reducing spasticity, increasing actual use of the affected upper limb, and improving participation in daily life in stroke patients. This study provided an integrated innovative intervention, which may be a promising therapy to improve upper limb function recovery in stroke rehabilitation. However, this study has a small sample size, and thus a further larger-scale study is warranted to confirm the treatment efficacy. Trial registration This trial was registered under ClinicalTrials.gov ID No. NCT03350087, retrospectively registered, on November 22, 2017

中文翻译：

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间歇性 theta 脉冲刺激对中风患者上肢功能的基于虚拟现实的自行车训练的增强效果：一项双盲、随机对照试验

据报道，虚拟现实和手臂骑行是改善中风患者上肢运动恢复的有效治疗方法。间歇性 theta 脉冲刺激 (iTBS) 可以增加同侧皮质兴奋性，并且越来越多地用于中风患者。然而，很少有研究检查 iTBS 对神经康复计划的增强作用。在这项研究中，我们调查了 iTBS 对基于虚拟现实的自行车训练 (VCT) 中风患者上肢功能的增强作用。在这项随机对照试验中，招募了 23 名中风患者。除了 VCT 之外，每位患者在同一天还接受了 15 次 iTBS 或假刺激。在干预之前和之后评估结果测量。改善上肢运动功能和痉挛的主要结局指标是 Fugl-Meyer 评估-上肢 (FMA-UE) 和改良 Ashworth 量表上肢 (MAS-UE)。活动和参与的次要结果测量是行动研究手臂测试 (ARAT)、九孔钉测试 (NHPT)、箱式和块式测试 (BBT) 和运动活动日志 (MAL) 和中风影响量表 (SIS)。进行Wilcoxon符号秩检验以评估干预后的有效性，并进行Mann-Whitney U检验以比较两组之间的治疗效果。治疗后，两组在 FMA-UE 和 ARAT 方面均表现出显着改善，而只有 iTBS + VCT 组在 MAS-UE、BBT、NHPT、MAL 和 SIS 方面表现出显着改善。Mann-Whitney U 检验显示 iTBS + VCT 组在 MAS-UE、MAL-AOU 和 SIS 方面比假手术组有更大的改善。但组间FMA-UE、ARAT、BBT、NHPT和MAL-QOM的变化无显着差异。间歇性 TBS 对 VCT 显示出增强的疗效，可减少痉挛，增加受影响上肢的实际使用，并改善中风患者对日常生活的参与。该研究提供了一种综合创新干预措施，可能是改善卒中康复中上肢功能恢复的一种有前景的疗法。然而，该研究样本量较小，因此需要进一步更大规模的研究来证实治疗效果。试验注册 本试验是在 ClinicalTrials.gov ID 号 NCT03350087 下注册的，