Riberholt Christian Gunge, Olsen Markus Harboe, Søndergaard Christian Baastrup, Gluud Christian, Ovesen Christian, Jakobsen Janus Christian, Mehlsen Jesper, Møller Kirsten
Traumatic Brain Injury Unit, Department of Neurorehabilitation, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Front Neurol. 2021 Apr 14;12:626014. doi: 10.3389/fneur.2021.626014. eCollection 2021.
Intensive rehabilitation of patients after severe traumatic brain injury aims to improve functional outcome. The effect of initiating rehabilitation in the early phase, in the form of head-up mobilization, is unclear. To assess whether early mobilization is feasible and safe in patients with traumatic brain injury admitted to a neurointensive care unit. This was a randomized parallel-group clinical trial, including patients with severe traumatic brain injury (Glasgow coma scale <11 and admission to the neurointensive care unit). The intervention consisted of daily mobilization on a tilt-table for 4 weeks. The control group received standard care. Outcomes were the number of included participants relative to all patients with traumatic brain injury who were approached for inclusion, the number of conducted mobilization sessions relative to all planned sessions, as well as adverse events and reactions. Information on clinical outcome was collected for exploratory purposes. Thirty-eight participants were included (19 in each group), corresponding to 76% of all approached patients [95% confidence interval (CI) 63-86%]. In the intervention group, 74% [95% CI 52-89%] of planned sessions were carried out. There was no difference in the number of adverse events, serious adverse events, or adverse reactions between the groups. Early head-up mobilization is feasible in patients with severe traumatic brain injury. Larger randomized clinical trials are needed to explore potential benefits and harms of such an intervention. [ClinicalTrials.gov], identifier [NCT02924649]. Registered on 3rd October 2016.
重度创伤性脑损伤患者的强化康复旨在改善功能预后。以床头抬高活动的形式在早期开展康复的效果尚不清楚。本研究旨在评估早期活动对于入住神经重症监护病房的创伤性脑损伤患者是否可行及安全。这是一项随机平行组临床试验，纳入重度创伤性脑损伤患者（格拉斯哥昏迷量表评分<11分且入住神经重症监护病房）。干预措施为在倾斜床上每日进行4周的活动。对照组接受标准护理。结局指标包括纳入研究的参与者数量相对于所有被邀请纳入研究的创伤性脑损伤患者数量的比例、实际进行的活动次数相对于所有计划活动次数的比例，以及不良事件和反应。收集临床结局信息用于探索性目的。共纳入38名参与者（每组19名），占所有被邀请患者的76%[95%置信区间（CI）63 - 86%]。在干预组，74%[95%CI 52 - 89%]的计划活动得以实施。两组之间在不良事件、严重不良事件或不良反应的数量上没有差异。早期床头抬高活动对于重度创伤性脑损伤患者是可行的。需要开展更大规模的随机临床试验来探索这种干预的潜在益处和危害。[ClinicalTrials.gov]，标识符[NCT02924649]。于2016年10月3日注册。
