Article Text

PDF
Multicentre, randomised clinical trial of paediatric concussion assessment of rest and exertion (PedCARE): a study to determine when to resume physical activities following concussion in children
  1. Andrée-Anne Ledoux1,
  2. Nicholas J Barrowman1,
  3. Kathy Boutis2,
  4. Adrienne Davis2,
  5. Sarah Reid1,3,
  6. Gurinder Sangha4,
  7. Ken J Farion1,3,
  8. Kevin Belanger1,
  9. Mark S Tremblay1,
  10. Keith Owen Yeates5,
  11. Carol DeMatteo6,
  12. Nick Reed7,
  13. Roger Zemek1,3
  14. Pediatric Emergency Research Canada PedCARE team
  1. 1 Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada
  2. 2 Department of Pediatrics, Hospital for Sick Children, Toronto, Canada
  3. 3 Department of Pediatrics, Children’s Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada
  4. 4 Pediatric Emergency Medicine, Children's Hospital London Health Sciences Centre, London, Ontario, Canada
  5. 5 Department of Psychology, Alberta Children’s Hospital Research Institute, University of Calgary, Calgary, Canada
  6. 6 School of Rehabilitation Science, McMaster University, Hamilton, Canada
  7. 7 Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada
  1. Correspondence to Dr Roger Zemek, Children’s Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Ottawa, ON K1H 8L1, Canada; rzemek{at}cheo.on.ca

Abstract

Introduction 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.

Methods and analysis 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.

Discussion 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 registration number Trial identifier (Clinicaltrials.gov) NCT02893969.

  • concussion
  • persistent post-concussive symptom
  • intervention
  • physical activity
  • rest
  • guidelines
  • pediatric
  • randomized clinical trial

Statistics from Altmetric.com

Footnotes

  • Contributors RZ and NR conceived the study. AAL, RZ, NR, NB, CD, SR, KB, AD, GS, KJF, KB, KOY and MST contributed to the study design and contributed to the writing of the trial protocol. AAL and RZ prepared the first draft of the manuscript, AAL, NR, CD, SR, KB, AD, GS, KJF, KB, KOY and MST contributed to editing the manuscript and read and approved the final manuscript.

  • Funding This work was supported by Ontario SPOR Support Unit - IMPACT-Child Health Award, the Ontario Neurotrauma Foundation, and the CHEO Foundation.

  • Disclaimer The authors have no conflict of interest to disclose.

  • Competing interests RZ is supported by a clinical research chair in pediatric concussion by the University of Ottawa Brain and Mind Research Institute.

  • Ethics approval CHEORI REB, SickKids REB and London Children Hospital REB.

  • Provenance and peer review Commissioned; externally peer reviewed.

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.