Effect of Progressive Early Mobilization on Functional Recovery in Patients With Moderate-Severe Traumatic Brain Injury: a Single Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- The total score-change of the Perme ICU Mobility Score
研究概览
简要总结
traumatic brain injury (TBI) is a major public health concern worldwide. Patients with moderate-severe TBI have high rates of disability at the acute phase and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols for critical trauma patients may minimize the functional declines during intensive care unit (ICU) stays. However, prior early mobilization studies have found that the survivors of moderate-severe TBI often experience a greater incidence of neurological injuries with other organ injury than other critical care patients. No randomized controlled trials thus far have utilized measure the influence or effect of early progressive EM protocols on the functional recovery of moderate-severe TBI patients.
详细描述
Objective
The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with moderate-severe TBI in a trauma ICU and (2) The goal is to investigate and compare the intervention effects of a progressive EM protocol (aimed at bringing patients at least to the mobility level-3 of sitting on the edge of bed) in an ICU on short-term and long-term functional abilities in patients with moderate-severe TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected to stay for at least 72 hours in the ICU,
- •>20 years of age with living independently before the onset of critical illness
- •relatively stable vital signs with a Glasgow Coma Scale (GCS) score of ≥6
- •relatively stable respiratory status (SpO2 >92%, high mechanical ventilator setting: FiO2 ≤60%, and positive end-expiratory pressure ≤10 cmH2O)
- •stable cardiovascular system (resting heart rate ≤130 bpm or no use of high-dose vasopressor of more than 0.2 μg kg-1 min-1)
排除标准
- •predicted mortality within the next 24 hours
- •palliative care
- •consistent increase of intracranial pressure (>20 mmHg)
- •pregnancy
- •uncontrolled seizure
- •active bleeding
- •ruptured or leaking aortic aneurysm
- •development of acute myocardial infarction during ICU stay
- •rapid development of degenerative neuromuscular diseases
- •contraindication for early walking
结局指标
主要结局
The total score-change of the Perme ICU Mobility Score
时间窗: at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset
The Perme ICU Mobility Score ranges from 0 to 32 points and is obtained by summing the score of 15 items, each one scored from 2 to 3 points. This score reflects the patient's mobility status in specific circumstances.
次要结局
- the achievement level of Modified Trauma ICU Mobility Scale(at baseline; at the time of ICU discharge; the time of hospital discharge)
- the hospital length of stay(up to 3 months)
- the values tested by in body s10 about lean body mass parameters(at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days;)
- The total score-change of the motor domain of the Functional Independence Measure (FIM-motor)(at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset)
- the days of achievement of the walking motor milestone(up to 3 months)
- the days of ventilator used(up to 3 months)
- the length of stay in the ICU(up to 3 months)
- the discharge disposition after hospital discharge(up to 3 months)