Estraneo Anna, Fiorentino Maria Rosaria, Magliacano Alfonso, Puopolo Maria Assunta, Rivetti Ilaria, Messa Maria Cristina
IRCCS Fondazione Don Carlo Gnocchi ONLUS, 50143 Florence, Italy.
IRCCS Fondazione Don Carlo Gnocchi ONLUS, 20148 Milan, Italy.
J Clin Med. 2025 Sep 20;14(18):6628. doi: 10.3390/jcm14186628.
: Upright position recovery (i.e., verticalization) is crucial in the rehabilitation of severe acquired brain injury (sABI). VErticalization by tilt table equipped with robotic-assisted lower limbs cyclic Mobilization (VEM) may facilitate a safer adaptation to vertical posture, reducing orthostatic hypotension occurrence. This multicenter randomized controlled trial (RCT) aims at investigating efficacy, safety, and usability of VEM compared to Traditional Verticalization (TV) using a conventional tilt table in cognitive-motor rehabilitation of sABI patients; : a total of 118 sABI patients with or emerged from prolonged Disorder of Consciousness (pDoC and eDoC) will be enrolled in six post-acute Neurorehabilitation Units and randomly allocated to VEM or TV arm (for each arm: total 25 sessions of 30 min daily treatment/5 days/week/5 weeks). Patients will undergo clinical-functional assessment, resting EEG recording and blood sampling, before, at the end of treatment, and after 1 month; : we will expect possible differences in safety and usability of verticalization between VEM and TV rehabilitative intervention and in their efficacy to improve clinical-functional findings and brain indices; : this RCT will provide new insights for the intensive, tailored and safe neurorehabilitation intervention in patients with sABI.
直立位恢复（即垂直化）在重度获得性脑损伤（sABI）的康复中至关重要。配备机器人辅助下肢循环活动的倾斜台进行垂直化（VEM）可能有助于更安全地适应垂直姿势，减少直立性低血压的发生。这项多中心随机对照试验（RCT）旨在研究在sABI患者的认知运动康复中，与使用传统倾斜台的传统垂直化（TV）相比，VEM的疗效、安全性和可用性；共有118例患有或已从长期意识障碍（pDoC和eDoC）中康复的sABI患者将被纳入6个急性后期神经康复单元，并随机分配到VEM组或TV组（每组：每天治疗30分钟，共25次，每周5天，共5周）。患者将在治疗前、治疗结束时和1个月后接受临床功能评估、静息脑电图记录和血液采样；我们预计VEM和TV康复干预在垂直化的安全性和可用性方面以及在改善临床功能结果和脑指标的疗效方面可能存在差异；这项RCT将为sABI患者的强化、个性化和安全的神经康复干预提供新的见解。
