Department of Neurorehabilitation, IRCCS San Raffaele Pisana, Via della Pisana, 235, 00163, Rome, Italy; San Raffaele University, Rome, Italy.
The BioRobotics Institute, Scuola Superiore Sant'Anna, V.le R. Piaggio 34, 56025, Pisa, Italy; Rehabilitation Bioengineering Laboratory, Volterra, Italy.
J Bodyw Mov Ther. 2020 Jan;24(1):194-198. doi: 10.1016/j.jbmt.2019.03.016. Epub 2019 Apr 4.
This study aims to analyse the long-term effects (6 months follow-up) of upper limb Robot-assisted Therapy (RT) compared to Traditional physical Therapy (TT), in subacute stroke patients. Although the literature on upper-limb rehabilitation with robots shows increasing evidence of its effectiveness in stroke survivors, the length of time for which the re-learned motor abilities could be maintained is still understudied. A randomized controlled follow-up study was conducted on 48 subacute stroke patients who performed the upper-limb therapy using a planar end-effector robotic system (Experimental Group-EG) or TT (Control Group-CG). The clinical assessments were collected at T0 (baseline), T1 (end of treatment) and T2 (6 months follow-up): Upper Limb part of Fugl-Meyer assessment (FM-UL), total passive Range Of Motion (pROM), Modified Ashworth Scale Shoulder (MAS-S) and Elbow (MAS-E). At T1, the intra-group analysis showed significant gain of FM-UL in both EG and CG, while significant improvement in MAS-S, MAS-E, and pROM were found in the EG only. At T2, significant increase in MAS-S were revealed only in the CG. In FM-UL, pROM and MAS-E the improvements obtained at the end of treatment seem to be maintained at 6 months follow-up in both groups. The inter-groups analysis of FM-UL values at T1 and T2 demonstrated significant differences in favour of EG. In conclusion, upper limb Robot-assisted Therapy may lead a greater reduction of motor impairment in subacute stroke patients compared to Traditional Therapy. The gains observed at the end of treatment persisted over time. No serious adverse events related to the study occurred.
本研究旨在分析上肢机器人辅助治疗（RT）与传统物理治疗（TT）相比在亚急性脑卒中患者中的长期效果（6 个月随访）。虽然关于机器人辅助上肢康复的文献表明其对脑卒中幸存者的有效性不断增加，但重新获得的运动能力可以维持多长时间仍有待研究。对 48 名使用平面末端效应器机器人系统（实验组-EG）或 TT（对照组-CG）进行上肢治疗的亚急性脑卒中患者进行了随机对照随访研究。临床评估在 T0（基线）、T1（治疗结束）和 T2（6 个月随访）时采集：Fugl-Meyer 上肢评估（FM-UL）、总被动关节活动度（pROM）、改良 Ashworth 量表肩部（MAS-S）和肘部（MAS-E）。在 T1 时，组内分析显示 EG 和 CG 中 FM-UL 均有显著改善，而仅在 EG 中发现 MAS-S、MAS-E 和 pROM 显著改善。在 T2 时，仅在 CG 中发现 MAS-S 显著增加。在 FM-UL、pROM 和 MAS-E 中，治疗结束时获得的改善在两组中似乎在 6 个月随访时得以维持。T1 和 T2 时 FM-UL 值的组间分析显示 EG 有显著优势。总之，与传统疗法相比，上肢机器人辅助治疗可能会使亚急性脑卒中患者的运动障碍得到更大程度的减轻。治疗结束时观察到的效果持续时间更长。与研究相关的严重不良事件未发生。
