Riberholt Christian Gunge, Lindschou Jane, Gluud Christian, Mehlsen Jesper, Møller Kirsten
Department of Neurorehabilitation/TBI unit, Rigshospitalet, University of Copenhagen, Kettegard Alle 30, 2650, Hvidovre, Denmark.
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 7812, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.
Trials. 2018 Nov 8;19(1):612. doi: 10.1186/s13063-018-3004-x.
Intensive rehabilitation of patients with severe traumatic brain injury is generally applied in the subacute stages of the hospital stay. Few studies have assessed the association between early and intensive physical rehabilitation and functional outcomes. The aim of this trial is to assess the feasibility of an intensive physical rehabilitation intervention focusing on mobilisation to the upright position, starting as early as clinically possible versus standard care in the intensive care unit. The feasibility study is intended to inform a subsequent randomised clinical trial that will investigate benefits and harms of the intervention.
This randomised clinical feasibility trial with a follow-up period of 1 year will use blinded outcome assessors for the Coma Recovery Scale-Revised. A maximum of 60 patients admitted to the neurointensive care unit at Rigshospitalet, Denmark, with traumatic brain injury (age of at least 18 years), a low level of consciousness, and stable intracranial pressure will be included in the trial. Patients will be randomly assigned to experimental intervention versus standard care (1:1) stratified according to their Glasgow Coma Score. The intervention group will receive daily mobilisation in a tilt table with an integrated stepping device (ERIGO). Feasibility is declared if more than 60% (the lower 95% confidence interval of the proportion) of eligible patients are included in the trial and more than 52% (the lower 95% confidence interval of the proportion) of patients in the intervention group receive more than 60% of the planned interventions. Safety is assessed by the occurrence of adverse events and adverse reactions. Exploratory clinical outcomes consist of cerebral haemodynamics (blood flow velocity and pressure autoregulation) and baroreceptor sensitivity in the early phase as well as functional outcomes (Coma Recovery Scale-Revised, Early Functional Ability scale, and Functional Independence Measure).
Our findings will inform a future, larger-scale randomised clinical trial on early mobilisation using a tilt table early after severe traumatic brain injury.
ClinicalTrials.gov identifier: NCT02924649 . Registered on 3 October 2016.
重度创伤性脑损伤患者的强化康复通常在住院的亚急性期进行。很少有研究评估早期强化物理康复与功能结局之间的关联。本试验的目的是评估一种强化物理康复干预措施的可行性，该干预措施侧重于尽早在临床上可行时将患者移动至直立位，与重症监护病房的标准护理进行对比。该可行性研究旨在为后续的随机临床试验提供信息，该试验将调查该干预措施的益处和危害。
这项随访期为1年的随机临床可行性试验将对昏迷恢复量表修订版使用盲法结局评估者。丹麦里格霍斯医院神经重症监护病房收治的最多60例创伤性脑损伤（年龄至少18岁）、意识水平低且颅内压稳定的患者将纳入试验。患者将根据其格拉斯哥昏迷评分分层，随机分配至实验性干预组与标准护理组（1:1）。干预组将在带有集成踏步装置（ERIGO）的倾斜台上每日进行移动训练。如果超过60%（比例的95%置信区间下限）的符合条件患者纳入试验，且干预组超过52%（比例的95%置信区间下限）的患者接受超过60%的计划干预，则宣布该试验可行。通过不良事件和不良反应的发生情况评估安全性。探索性临床结局包括早期的脑血流动力学（血流速度和压力自动调节）和压力感受器敏感性以及功能结局（昏迷恢复量表修订版、早期功能能力量表和功能独立性测量）。
我们的研究结果将为未来一项关于重度创伤性脑损伤后早期使用倾斜台进行早期移动训练的更大规模随机临床试验提供信息。
ClinicalTrials.gov标识符：NCT02924649。于2016年10月3日注册。
