Verola Sofia, Ugolini Alessandro, Pellicciari Leonardo, Di Bari Mauro, Paci Matteo
Department of Allied Health Professions, Azienda USL Toscana Centro, Florence - Italy.
Independent Researcher, Empoli (FI) - Italy.
Arch Physiother. 2025 May 23;15:118-130. doi: 10.33393/aop.2025.3209. eCollection 2025 Jan-Dec.
Recent randomized clinical trials (RCTs) provide evidence on the effects of robot-assisted training (RAT) for upper limb impairments in stroke subjects; however, evidence on the clinical relevance of these differences is lacking. This study aimed to perform a systematic review with meta-analyses of RCTs on clinical relevance, expressed as minimal clinically important difference (MCID), of RAT to improve independence in activities of daily living, arm function, and impairments in patients with stroke.
Four databases were searched. RCTs investigating RAT aimed at recovering motor and functional skills of the upper limb in adult post-stroke patients were included. MCID values were retrieved from specific databases. Two independent reviewers performed screening, data extraction, and assessment of methodological quality. Meta-analyses for both statistical significance and clinical relevance were performed. Clinical relevance was expressed as a standardized MCID overall score (SMOS) for each outcome measure, calculated as the difference between mean outcome measures in experimental and control groups divided by corresponding MCID, when available.
Eighty-five studies were included. Conventional meta-analyses showed that RAT, compared to control, had significant effects in the domains of activities of daily living, dexterity, arm function, and strength, but not on pain. Meta-analyses for clinical relevance reported non-clinically relevant differences between groups for all domains.
RAT produces some significant improvements for the upper limb, but these differences are not clinically relevant when compared to other therapies. Improvements in using the RAT in clinical practice may not be more clinically relevant than other therapies for stroke patients.
近期的随机临床试验(RCT)为机器人辅助训练(RAT)对中风患者上肢功能障碍的影响提供了证据;然而,关于这些差异的临床相关性的证据却很缺乏。本研究旨在对RCT进行系统评价和荟萃分析,以探讨RAT在改善中风患者日常生活活动独立性、上肢功能及功能障碍方面的临床相关性,用最小临床重要差异(MCID)表示。
检索了四个数据库。纳入了旨在恢复成年中风后患者上肢运动和功能技能的RCT。从特定数据库中获取MCID值。两名独立的评审员进行筛选、数据提取和方法学质量评估。对统计学意义和临床相关性都进行了荟萃分析。临床相关性用每个结局指标的标准化MCID总分(SMOS)表示,计算方法为实验组和对照组平均结局指标的差值除以相应的MCID(如有)。
纳入了85项研究。传统的荟萃分析表明,与对照组相比,RAT在日常生活活动、灵活性、上肢功能和力量等方面有显著效果,但对疼痛无影响。临床相关性的荟萃分析报告,各领域组间差异无临床相关性。
RAT对上肢有一些显著改善,但与其他疗法相比,这些差异无临床相关性。在临床实践中使用RAT的改善可能并不比其他中风治疗方法更具临床相关性。