Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion.
研究概览
简要总结
In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.
详细描述
Specific Aims:
To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort after an acute concussion.
To determine if active rehabilitation compared to routine care reduces the risk of PCS for high-risk patients.
This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute concussion diagnosis will be eligible. All patients will receive pedometers to monitor their activity levels. If the patient is in the control group the patient will receive standard concussion management per the treating ED physician. Patients in the active rehabilitation group will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers.
One to five days after the ED concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient diagnosed with an acute concussion within 48 hours
- •Patient greater than 8 and less than 19 years old
排除标准
- •Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD)
- •Cognitive delay
- •GCS < 14
- •positive findings on head CT
- •Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
结局指标
主要结局
We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion.
时间窗: 28 to 32 days post Emergency Department
We hypothesize that subjects managed with active rehabilitation post an acute concussion will have a 20% decreased relative risk of PCS compared to those managed with standard care.
次要结局
未报告次要终点
研究者
Jeremy Root
Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine
Children's National Research Institute