Effect of Early Rest on Recovery From Pediatric Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Neurocognitive Outcomes
研究概览
简要总结
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
详细描述
The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion. This research is being done because, currently, there is no effective treatment for concussion. Physical activity (for example; running, playing sports) and brain activity (for example; homework and tests) may make concussion symptoms worse. We are studying whether strict rest after concussion may help improve symptoms. About 110 children, ages 11-22 years old will take part in this study at the Children's Hospital of Wisconsin. This study is being funded by the Injury Research Center. The research grant pays for study procedures, follow-up testing, and patient reimbursement. Research staff is not being provided incentives to enroll subjects.
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 (Investigator)
入排标准
- 年龄范围
- 11 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •11-22 years
- •present to the Emergency Department within 24 hours of a head injury
排除标准
- •patients who are being admitted,
- •non-English speaking patient/family,
- •mental retardation (IQ < 70)
- •Suspected intoxication
- •restricted used of dominant hand or limited vision
- •injury or conditions affecting balance assessment
- •prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy)
- •known intracranial injury (e.g., intracranial bleeding, cerebral contusion)
- •patients for whom a legal guardian is not present or cannot be contacted.
- •ED clinician preference
研究组 & 干预措施
Standard of Care
In this group, the treating attending physician will be free to make rest recommendations as they see fit. An internal survey of physician practice found that the vast majority of physicians instruct patients rest for 1-2 days, then to return to school and physical activity after the patient's symptoms have resolved. The amount of rest will vary from patients to patient based on variation in symptom resolution and patient compliance. This advice is consistent with best practices outlined by the CDC.
Intervention
Mandated Rest.
干预措施: Mandated Rest, Intervention (Behavioral)
结局指标
主要结局
Neurocognitive Outcomes
时间窗: 10 days post injury
Neurocogntive outcomes assessed using computer-based neurocogntive testing based on changes from scores obtained in the emergency department to scores obtained at 3 days and 10 days.
次要结局
- Ancillary Neurocogntive Test Battery(10 days)
- Parental Attitude to Concussion:(10 days)
研究者
Danny Thomas
Assistant Professor of Pediatrics
Medical College of Wisconsin