The Center of Rehabilitation Therapy, the First Rehabilitation Hospital of Shanghai, No.349 Hangzhou Rd., Yangpu District, Shanghai, 200090, China.
Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.
Trials. 2022 Jun 28;23(1):538. doi: 10.1186/s13063-022-06361-2.
Impairments in upper limb motor function and cognitive ability are major health problems experienced by stroke patients, necessitating the development of novel and effective treatment options in stroke care. The aim of this study is to examine the effects of robot-assisted therapy on improving upper limb and cognitive functions in stroke patients.
This will be a single-blinded, 2-arm, parallel design, randomized controlled trial which will include a sample size of 86 acute and subacute stroke patients to be recruited from a single clinical hospital in Shanghai, China. Upon qualifying the study eligibility, participants will be randomly assigned to receive either robot-assisted therapy or conventional therapy with both interventions being conducted over a 6-week period in a clinical rehabilitation setting. In addition to comprehensive rehabilitation, the robot-assisted therapy group will receive a 30-min Armguider robot-assisted therapy intervention 5 days a week. Primary efficacy outcomes will include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Mini-Mental Status Examination (MMSE). Other secondary outcomes will include Trail Making Test (TMT), Auditory Verbal Learning Test (AVLT), Digit Symbol Substitution Test (DSST), and Rey-Osterrieth Complex Figure Test (ROCFT). All trial outcomes will be assessed at baseline and at 6-week follow-up. Intention-to-treat analyses will be performed to examine changes from baseline in the outcomes. Adverse events will be monitored throughout the trial period.
This will be the first randomized controlled trial aimed at examining the effects of robot-assisted therapy on upper limb and cognitive functions in acute and subacute stroke patients. Findings from the study will contribute to our understanding of using a novel robotic rehabilitation approach to stroke care and rehabilitation.
Chinese Clinical Trial Registry ChiCTR2100050856 . Registered on 5 September 2021.
上肢运动功能和认知能力受损是中风患者面临的主要健康问题，因此需要开发新的有效的中风治疗方法。本研究旨在探讨机器人辅助治疗对改善中风患者上肢和认知功能的影响。
这将是一项单盲、2 臂、平行设计、随机对照试验，纳入 86 名来自中国上海某家临床医院的急性和亚急性中风患者。在符合研究纳入标准后，参与者将被随机分配接受机器人辅助治疗或常规治疗，干预均在临床康复环境中进行 6 周。除了综合康复外，机器人辅助治疗组将接受每周 5 天、每次 30 分钟的 ArmGuider 机器人辅助治疗。主要疗效结局将包括上肢 Fugl-Meyer 评估（FMA-UE）和简易精神状态检查（MMSE）。其他次要结局将包括连线测试（TMT）、听觉词语学习测试（AVLT）、数字符号替代测试（DSST）和 Rey-Osterrieth 复杂图形测试（ROCFT）。所有试验结局均在基线和 6 周随访时评估。将进行意向治疗分析以检查结局从基线的变化。整个试验期间将监测不良事件。
这将是第一项旨在研究机器人辅助治疗对急性和亚急性中风患者上肢和认知功能影响的随机对照试验。该研究的结果将有助于我们了解使用新型机器人康复方法进行中风治疗和康复。
中国临床试验注册中心 ChiCTR2100050856。注册于 2021 年 9 月 5 日。
