Pediatric Concussion Assessment of Rest and Exertion (PedCARE)
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|ClinicalTrials.gov Identifier: NCT02893969|
Recruitment Status : Completed
First Posted : September 9, 2016
Last Update Posted : January 29, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Concussions Post-Concussive Symptoms||Behavioral: Physical Activity Behavioral: Rest||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||March 6, 2017|
|Actual Primary Completion Date :||January 25, 2021|
|Actual Study Completion Date :||January 25, 2021|
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.
Complete physical rest until asymptomatic.
- 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
- 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.
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, Learn About Clinical Studies.
|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893969
|Children's Hospital of Eastern Ontario|
|Principal Investigator:||Roger L Zemek, MD||CHEO|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Roger Zemek, Associate Professor, Dept. of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario|
|Other Study ID Numbers:||
|First Posted:||September 9, 2016 Key Record Dates|
|Last Update Posted:||January 29, 2021|
|Last Verified:||January 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Head Injuries, Closed
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries