Abstract: Objective  To compare the clinical efficacy of rehabilitation brain-computer interface (BCI) and motor imagery (MI) therapy on upper limb motor function in stroke patients with the affected hand in the flaccid paralysis phase. 
Methods  Stroke patients with hand dysfunction in the flaccid paralysis phase who were admitted to the Department of Rehabilitation Medicine, The First Affiliated Hospital of Henan Medical University and The Third Affiliated Hospital of Henan Medical University from October 2023 to July 2024, were prospectively and consecutively enrolled and randomly divided into the BCI group and the MI group at a 1∶1 ratio. In addition to conventional rehabilitation training, the BCI group underwent MI-based rehabilitation BCI training, while the MI group received MI training. The training frequency for both groups was six days per week, one session per day, and 30 minutes per session, for two consecutive weeks. Before intervention, one week after intervention, and two weeks after intervention, the Fugl-Meyer motor assessment-upper extremity (FMA-UE) was used to evaluate the patients’ upper limb motor function (shoulder/elbow, wrist/hand), the modified Ashworth scale (MAS) was used to assess the muscle tone of patients’ upper limb (biceps brachii and triceps brachii), and the modified Barthel index (mBI) was used to evaluate the patients’ activities of daily living. Adverse reactions possibly related to rehabilitation BCI device use were recorded. Within-group differences across the assessment time points and between-group differences following the intervention were compared for all outcome measures.
Results  A total of 37 patients were enrolled, including 18 in the BCI group and 19 in the MI group. After two weeks of intervention, the total FMA-UE score, FMA-UE shoulder/elbow subscore, FMA-UE wrist/hand subscore, and mBI score in both groups were significantly improved compared with those before intervention, with statistically significant differences. After two weeks of intervention, the BCI group demonstrated better outcomes than the MI group in the total FMA-UE score (P=0.006), FMA-UE wrist/hand subscore (P<0.001), and mBI score (P=0.022), with statistically significant differences. 
However, no statistically significant difference was found in the FMA-UE shoulder/elbow subscore between the two groups (P=0.057). Regarding MAS grades at one week and two weeks after intervention, there were no statistically significant differences either within each group or between the two groups. No adverse reactions related to the use of the rehabilitation BCI device were reported by any patient.
Conclusions  Rehabilitation BCI can improve upper limb motor function and effectively enhance the activities of daily living in stroke patients during the flaccid paralysis phase, with good safety. Compared with conventional MI training, rehabilitation BCI training demonstrates superior efficacy in rehabilitating distal upper limb function.

Key words: Rehabilitation brain-computer interface; Motor imagery; Stroke; Upper limb motor function rehabilitation

摘要： 目的 对比康复脑机接口（brain-computer interface，BCI）与运动想象（motor imagery，MI）疗法对患手处于弛缓性瘫痪期的卒中患者上肢运动功能的康复效果。
方法 前瞻性、连续纳入2023年10月—2024年7月在河南医药大学第一附属医院、河南医药大学第三附属医院康复医学科住院，存在手功能障碍且患手处于弛缓性瘫痪期的卒中患者，按1∶1的比例将患者随机分为BCI组和MI组。BCI组在常规康复训练的基础上，接受基于MI的康复BCI训练，MI组仅接受MI训练，训练频率均为每周6 d，每日1次，每次30 min，持续2周。分别于干预前、干预1周后及干预2周后，采用Fugl-Meyer运动功能评定量表上肢部分（Fugl-Meyer motor assessment-upper extremity，FMA-UE）评估患者的上肢运动功能（肩肘、腕手），采用改良Ashworth量表（modified Ashworth scale，MAS）评估患者的上肢肌张力（肱二头肌、肱三头肌），采用改良Barthel指数（modified Barthel index，mBI）评估患者的日常生活活动能力。记录可能与康复BCI设备使用相关的不良反应，比较上述指标在干预前后的组内差异及干预后的组间差异。
结果 共纳入患者37例，BCI组18例，MI组19例。干预2周后，两组的FMA-UE评分、FMA-UE肩肘部分评分、FMA-UE腕手部分评分和mBI评分较本组干预前均有改善，差异具有统计学意义。干预2周后，BCI组的FMA-UE评分（P=0.006）、FMA-UE腕手部分评分（P＜0.001）及mBI评分（P=0.022）均优于MI组，差异具有统计学意义；两组FMA-UE肩肘部分评分的差异无统计学意义（P=0.057）。在干预1周后及干预2周后的MAS分级方面，两组组内及组间比较的差异均无统计学意义。所有患者均未报告与康复BCI设备使用相关的不良反应。
结论 康复BCI可改善卒中弛缓性瘫痪期患者的上肢运动功能，有效提升其日常生活活动能力，且安全性较好。与传统MI训练相比，康复BCI训练在上肢远端功能康复方面表现出一定的优势。

关键词: 康复脑机接口; 运动想象; 卒中; 上肢运动功能康复