Abstract:
Repetitive focal muscle vibration (rMV) is known to promote neural plasticity and long-lasting motor recovery in chronic stroke patients. Those structural and functional changes within the motor network underlying motor recovery occur in the very first hours after stroke. Nonetheless, to our knowledge, no rMV-based studies have been carried out in acute stroke patients so far, and the clinical benefit of rMV in this phase of stroke is yet to be determined. The aim of this randomized double-blind sham-controlled study is to investigate the short-term effect of rMV on motor recovery in acute stroke patients. Out of 22 acute stroke patients, 10 were treated with the rMV (vibration group-VG), while 12 underwent the sham treatment (control group-CG). Both treatments were carried out for 3 consecutive days, starting within 72 h of stroke onset; each daily session consisted of three 10-min treatments (for each treated limb), interspersed with a 1-min interval. rMV was delivered using a specific device (Cro®System, NEMOCO srl, Italy). The transducer was applied perpendicular to the target muscle\'s belly, near its distal tendon insertion, generating a 0.2-0.5 mm peak-to-peak sinusoidal displacement at a frequency of 100 Hz. All participants also underwent a daily standard rehabilitation program. The study protocol underwent local ethics committee approval (ClinicalTrial.gov NCT03697525) and written informed consent was obtained from all of the participants. With regard to the different pre-treatment clinical statuses, VG patients showed significant clinical improvement with respect to CG-treated patients among the NIHSS (p < 0.001), Fugl-Meyer (p = 0.001), and Motricity Index (p < 0.001) scores. In addition, when the upper and lower limb scales scores were compared between the two groups, VG patients were found to have a better clinical improvement at all the clinical end points. This study provides the first evidence that rMV is able to improve the motor outcome in a cohort of acute stroke patients, regardless of the pretreatment clinical status. Being a safe and well-tolerated intervention, which is easy to perform at the bedside, rMV may represent a valid complementary non-pharmacological therapy to promote motor recovery in acute stroke patients.
摘要:
已知重复局灶性肌肉振动(rMV)可促进慢性中风患者的神经可塑性和持久的运动恢复。在运动恢复基础上的运动网络内的那些结构和功能变化发生在中风后的最初几个小时。尽管如此,根据我们的知识,到目前为止,还没有对急性中风患者进行基于rMV的研究,rMV在卒中这一阶段的临床获益尚待确定。这项随机双盲假对照研究的目的是研究rMV对急性中风患者运动恢复的短期影响。在22名急性中风患者中,10例接受rMV(振动组-VG)治疗,12人接受假治疗(对照组-CG)。两种治疗均连续进行3天,在卒中发作的72小时内开始;每个每日疗程包括三个10分钟的治疗(对于每个治疗的肢体),间隔1分钟。rMV使用特定设备(Cro®系统,NEMOCOsrl,意大利)。传感器垂直于目标肌肉的腹部,靠近其远端肌腱插入,在100Hz的频率下产生0.2-0.5mm的峰-峰正弦位移。所有参与者还接受了每日标准的康复计划。研究方案经过当地伦理委员会批准(ClinicalTrial.govNCT03697525),并获得所有参与者的书面知情同意书。关于不同的治疗前临床状态,在NIHSS中,VG患者相对于CG治疗的患者显示出显着的临床改善(p<0.001),Fugl-Meyer(p=0.001),和运动指数(p<0.001)得分。此外,当比较两组的上肢和下肢评分时,发现VG患者在所有临床终点均具有更好的临床改善。这项研究提供了第一个证据表明rMV能够改善急性中风患者队列的运动结果,无论预处理的临床状态。作为一种安全且耐受性良好的干预措施,这很容易在床边执行,rMV可能是促进急性中风患者运动恢复的有效补充非药物治疗。