Bernhardt Julie, Dewey Helen, Thrift Amanda, Collier Janice, Donnan Geoffrey
National Stroke Research Institute, Level 1, Neurosciences Building, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg, 3081 Victoria, Australia.
Stroke. 2008 Feb;39(2):390-6. doi: 10.1161/STROKEAHA.107.492363. Epub 2008 Jan 3.
Very early rehabilitation, with an emphasis on mobilization, may contribute to improved outcomes after stroke. We hypothesized that a very early rehabilitation protocol would be safe and feasible.
We performed a randomized, controlled trial with blinded outcome assessment. Patients at <24 hours after stroke were recruited from 2 Melbourne metropolitan stroke units. Patients were randomly assigned to receive standard care (SC) or SC plus very early mobilization (VEM) until discharge or 14 days (whichever was sooner). The primary safety outcome was the number of deaths at 3 months. The primary feasibility outcome was a higher "dose" of mobilization achieved in VEM. Secondary safety outcomes included adverse events (including falls and early neurologic deterioration), compliance with physiologic monitoring criteria, and patient fatigue after interventions. Secondary feasibility outcomes included "contamination" of standard care.
Overall, 18% of patients screened were suitable for recruitment. Seventy-one patients were recruited and randomized, with 2 dropouts by 12 months. The majority experienced ischemic strokes (87%). The group mean+/-SD age was 74.7+/-12.5 years, and 58% (n=41) had a National Institutes of Health Stroke Scale score >7. There was no significant difference in the number of deaths between groups (SC, 3 of 33; VEM, 8 of 38; P=0.20). Almost all deaths occurred in patients with severe stroke. Secondary safety outcomes were similar between groups. The intervention protocol was successfully delivered, achieving VEM dose targets (double SC, P=0.003) and faster time to first mobilization (P<0.001).
VEM of patients within 24 hours of acute stroke appears safe and feasible. Intervention efficacy and cost-effectiveness are currently being tested in a large randomized, controlled trial.
极早期康复，重点在于活动能力训练，可能有助于改善卒中后的预后。我们假设极早期康复方案是安全可行的。
我们进行了一项随机对照试验，对结果评估采用盲法。从墨尔本市区的2个卒中单元招募卒中后<24小时的患者。患者被随机分配接受标准护理（SC）或SC加极早期活动能力训练（VEM），直至出院或14天（以先到者为准）。主要安全结局是3个月时的死亡人数。主要可行性结局是VEM组实现更高的活动能力训练“剂量”。次要安全结局包括不良事件（包括跌倒和早期神经功能恶化）、对生理监测标准的依从性以及干预后患者疲劳情况。次要可行性结局包括标准护理的“沾染”情况。
总体而言，18%的筛查患者适合入组。共招募71例患者并随机分组，12个月时有2例退出。大多数患者发生缺血性卒中（87%）。组平均年龄±标准差为74.7±12.5岁，58%（n = 41）的美国国立卫生研究院卒中量表评分>7。两组间死亡人数无显著差异（SC组33例中有3例死亡；VEM组38例中有8例死亡；P = 0.20）。几乎所有死亡都发生在重症卒中患者中。两组间次要安全结局相似。干预方案成功实施，达到了VEM剂量目标（是SC组的两倍，P = 0.003），且首次活动能力训练的时间更快（P<0.001）。
急性卒中24小时内对患者进行VEM似乎是安全可行的。目前正在一项大型随机对照试验中测试干预效果和成本效益。
