Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
Department of Pediatrics, Hospital for Sick Children, Toronto, Canada.
Br J Sports Med. 2019 Feb;53(3):195. doi: 10.1136/bjsports-2017-097981. Epub 2017 Jul 12.
Rest until symptom-free, followed by a progressive stepwise return to activities, is often prescribed in the management of paediatric concussions. Recent evidence suggests prolonged rest may hinder recovery, and early resumption of physical activity may be associated with more rapid recovery postconcussion. The primary objective is to determine whether the early reintroduction of non-contact physical activity beginning 72 hours postinjury reduces postconcussive symptoms at 2 weeks in children following an acute concussion as compared with a rest until asymptomatic protocol.
This study is a randomised clinical trial across three Canadian academic paediatric emergency departments. A total of 350 participants, aged 10-17.99 years, who present within 48 hours of an acute concussion, will be recruited and randomly assigned to either the study intervention protocol (resumption of physical activity 72 hours postconcussion even if experiencing symptoms) or physical rest until fully asymptomatic. Participants will document their daily physical and cognitive activities. Follow-up questionnaires will be completed at 1, 2 and 4 weeks postinjury. Compliance with the intervention will be measured using an accelerometer (24 hours/day for 14 days). Symptoms will be measured using the validated Health and Behaviour Inventory. A linear multivariable model, adjusting for site and prognostically important covariates, will be tested to determine differences between groups. The proposed protocol adheres to the RCT-CONSORT guidelines.
This trial will determine if early resumption of non-contact physical activity following concussion reduces the burden of concussion and will provide healthcare professionals with the evidence by which to recommend the best timing of reintroducing physical activities.
Trial identifier (Clinicaltrials.gov) NCT02893969.
在小儿脑震荡的治疗中，常规定期休息至症状消失，然后逐步恢复活动。最近的证据表明，长时间休息可能会阻碍康复，早期恢复体育活动可能与脑震荡后更快的康复有关。主要目的是确定与休息至无症状方案相比，受伤后 72 小时内早期重新引入非接触性体育活动是否会减少急性脑震荡后 2 周时患儿的脑震荡后症状。
这是一项在加拿大三家学术性儿科急诊室进行的随机临床试验。共招募 350 名年龄在 10-17.99 岁之间、急性脑震荡后 48 小时内就诊的患者，并将其随机分配到研究干预组（即使有症状，也在脑震荡后 72 小时恢复体育活动）或身体休息至完全无症状。参与者将记录他们的日常身体和认知活动。伤后 1、2 和 4 周时将完成随访问卷。使用加速度计（14 天 24 小时/天）测量干预的依从性。症状将使用经过验证的健康和行为量表进行测量。将测试线性多变量模型，调整部位和预后重要的协变量，以确定组间差异。该方案符合 RCT-CONSORT 指南。
该试验将确定脑震荡后早期恢复非接触性体育活动是否会减轻脑震荡的负担，并为医疗保健专业人员提供重新引入体育活动的最佳时机的证据。
试验标识符（Clinicaltrials.gov）NCT02893969。
