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Pediatric Concussion Assessment of Rest and Exertion (PedCARE)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Roger Zemek, Children's Hospital of Eastern Ontario
Sponsor:
Collaborators:
Ontario SPOR SUPPORT UNIT
Holland Bloorview Kids Rehabilitation Hospital
Western University, Canada
The Hospital for Sick Children
Children's Hospital of Western Ontario
Information provided by (Responsible Party):
Roger Zemek, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT02893969
First received: August 2, 2016
Last updated: July 13, 2017
Last verified: July 2017
  Purpose
The goal of this study is to investigate when is the best time to resume physical activity following a head injury. Two treatment plans will be studied; the first treatment plan consists of gradually reintroducing physical activity in the child's routine, starting 72 hours following the head injury. The second treatment plan involves physical and mental rest until the child as no more symptoms. Once symptom free, physical activity is gradually reintroduced in the child's routine.

Condition Intervention
Concussions Post-Concussive Symptoms Behavioral: Physical Activity Behavioral: Rest

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Multicentre, Randomized Clinical Trial of Pediatric Concussion Assessment of Rest and Exertion (PedCARE): A Study to Determine When to Resume Physical Activities Following Concussion in Children

Resource links provided by NLM:


Further study details as provided by Roger Zemek, Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Health and Behaviour Inventory (HBI) [ Time Frame: 2 weeks ]
    The HBI is a 20-item self-report questionnaire, Likert scale (0, 1, 2, or 3 points) yielding separate scores for cognitive and somatic symptom scales for a total score range of 0 to 60


Secondary Outcome Measures:
  • Post-Concussion Symptom Inventory (PCSI) [ Time Frame: 2 and 4 weeks ]
    Post-Concussion Symptom Inventory (PCSI) will be used as a confirmatory instrument for defining a PPCS case. PCSI is a validated, comprehensive self-administered instrument that has been used in other pediatric concussion studies, and only one of two measures applicable to younger children with published validity and reliability data. For the purpose of this study the investigators will be using the PCSI pre-adolescent scale version (18-item, 3-point scale), encompassing physical, cognitive, emotional and sleep domains. The scale will be used for all the children in the study. This specific version has demonstrated excellent internal consistency (r=0.87 for children aged 8-12 years). The assessment will be included in the second and fourth week follow-ups.

  • The Pediatric Quality of Life Inventory™ version 4.0 (PedsQL-4.0) [ Time Frame: 2 and 4 weeks ]
    The PedsQL is a reliable and valid measure of health-related quality of life in healthy children and adolescents and those with acute and/or chronic health conditions.120 Parent versions exist for children aged 2 to 18 years (in 4-age groups) and child versions for those aged 5 and over. For this study only the child's version (ages 8-12 (appendix 16a) and ages 13-18 (appendix 16b)) will be used. The inventory covers four domains: physical, emotional, social and school and takes approximately 4 minutes to complete. The 18-item PedsQL™ Multidimensional Fatigue Scale is designed to measure fatigue in pediatric patients and comprises the General Fatigue Scale (6 items), Sleep-Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). The PedsQL™ Multidimensional Fatigue Scale has demonstrated excellent internal consistency reliability and validity. For the purpose of this study only the child version will be administered during the 2 and 4th week follow-up.

  • Pediatric Injury Functional Outcome Scale (PIFOS) [ Time Frame: 2 and 4 weeks ]
    The PIFOS is an assessment that evaluates functional outcomes. The PIFOS is a 26-item structure interview, and is completed by caregivers. The assessment elicits ratings regarding motor skills, daily living skills, communication skills, cognition, social-emotional functioning, physical changes, and academic functioning.

  • 14 days physical activity monitoring with an Actical watch z-model [ Time Frame: 2 weeks ]
    The Actical will provide an objective measurement of activity/sedentary monitoring. The device is capable of encoding raw acceleration, activity counts, energy expenditure, physical activity intensity, body position, and amount of sleep. The device can store up to 32 MB data (194 days on the Epoch mode of 1 second) and the battery provides power for 180 days between charges. The Acticsl has been validated and is a reliable measure.

  • Patients long-term health-care utilization (e.g. what health care services patient access) and risks for concussion-related comorbidities, data will be collected through the Institute for Clinical Evaluative Sciences (ICES) data linkage. [ Time Frame: 20 years ]
    Investigating the long-term health-care utilization of concussion patients and determining the risks for concussion-related comorbidities will be done with ICES data linkage.


Estimated Enrollment: 350
Actual Study Start Date: March 6, 2017
Estimated Study Completion Date: November 2038
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental group
Gradual reintroduction of non-contact physical activity at 72 hours post-concussion.
Behavioral: Physical Activity
After 72 hours of full physical rest patients will gradually reintroduce physical activity into their daily routine.
Sham Comparator: Control Group
Physical and cognitive rest post-injury until fully asymptomatic. Once asymptomatic participants can gradually reintroduce physical activity.
Behavioral: Rest
Complete physical rest until asymptomatic.

Detailed Description:

Persistent post-concussive symptoms (PPCS) pose long-term challenges and can impact negatively patients' health-related quality of life and functional outcomes. Preventing PPCS, pediatric concussion guidelines call for cognitive and physical rest. Strict physical activity restriction is recommended until symptom-free, followed by a progressive step-wise return to activities. Unfortunately, little evidence beyond expert opinion exists to guide health care professionals on how and when to best re-introduce physical activity to hasten recovery and reduce the burden of PPCS. Recent evidence suggests protracted rest may hinder recovery. In fact, early resumption of physical exercise has proven physiological, psychological and functional benefits in many other conditions, including stroke (a severe traumatic brain injury). Findings from pilot studies in children with PPCS support that early, active rehabilitation is associated with improved recovery.

The goal of this study is to investigate whether early reintroduction of non-contact, physical activity at 72-hour post-injury reduces the rate of PPCS in children following an acute concussion as compared to usual care stepwise resumption of activity only once fully asymptomatic as per the Zurich consensus return-to-play protocol.

The study is a multicentre, blind, randomized clinical trial. A total of 350 participants will be recruited from 3 Pediatric Emergency Research Canada (PERC) Emergency Departments (ED). Eligible children are those aged 10-17 years who sustained a concussion in the previous 48 hours. Participants will be randomized to either the experimental intervention group or the the control group. The experimental intervention group consist of resumption of light, aerobic exercise (e.g., 15 minute walk) 72 hours post-injury, irrespective of symptoms. Patients will be allowed to progress activity daily using one of the following of their choice: Frequency, Intensity, Time (duration), or Type, as long as symptoms are well-tolerated, with a minimum of 24 hours between each step. Control group: Usual care according to Zurich return-to-play guidelines (complete rest until full resolution of concussion symptoms [several weeks of rest may be required prior to initiation], followed by stepwise activity progression).

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects presenting to one of the study hospital EDs after sustaining a direct or indirect head injury will be eligible if they:

  • aged 10 through 17.99 years;
  • have a concussion, defined by Zurich consensus statement;
  • suffered the initial injury in the previous 48 hours;
  • are proficient in English or French.

Exclusion Criteria:

Patients will be excluded if they present with traumatic head injuries with any of the following:

  • Glasgow Coma Scale ≤13;
  • abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated);
  • neurosurgical operative intervention, intubation or intensive care required;
  • multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria);
  • severe chronic neurological developmental delay resulting in communication difficulties; intoxication at the time of ED presentation as per clinician judgment;
  • no clear history of trauma as primary events (e.g., seizure, syncope or migraine);
  • inability to resume physical activities (e.g., fractured extremity or other concomitant injuries);
  • inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.);
  • legal guardian not present (certain forms need be completed by parents/legal guardians).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02893969

Contacts
Contact: Roger L Zemek, MD 613-737-7600 ext 3963 rzemek@cheo.on.ca
Contact: Candice McGahern 613-737-7600 ext 4111 cmcgahern@cheo.on.ca

Locations
Canada
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Canada
Contact: Sabrina Hamer    613-737-7600 ext 3923    shamer@cheo.on.ca   
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Ontario SPOR SUPPORT UNIT
Holland Bloorview Kids Rehabilitation Hospital
Western University, Canada
The Hospital for Sick Children
Children's Hospital of Western Ontario
Investigators
Principal Investigator: Roger L Zemek, MD CHEO
  More Information

Responsible Party: Roger Zemek, Associate Professor, Dept. of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02893969     History of Changes
Other Study ID Numbers: 16/80X
Study First Received: August 2, 2016
Last Updated: July 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Roger Zemek, Children's Hospital of Eastern Ontario:
Physical Activity
Rest

Additional relevant MeSH terms:
Post-Concussion Syndrome
Brain Concussion
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 21, 2017