Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Coma Recovery Scale change
研究概览
简要总结
Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI.
Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
- •diagnosis of vegetative state or minimally conscious state on the third day after the injury;
- •adequate pulmonary gas exchanging function;
- •stable hemodynamics
排除标准
- •sedation;
- •unstable intracranial pressure (ICP);
- •cerebral perfusion pressure (CPP) <60 mmHg;
- •fractures or skin lesions in thorax, abdomen or lower limbs;
- •deep vein thrombosis;
- •body weight >130 kg; height >210 cm.
结局指标
主要结局
Coma Recovery Scale change
时间窗: through study completion, average 18 weeks
Glasgow Coma Scale change
时间窗: through study completion, average 18 weeks
Levels of Cognitive Functioning change
时间窗: through study completion, average 18 weeks
Disability Rating Scale change
时间窗: through study completion, average 18 weeks
次要结局
未报告次要终点
研究者
Ilaria Zivi
MD
Ospedale Generale Di Zona Moriggia-Pelascini