Pediatric Concussion Assessment of Rest and Exertion (NCT02893969) | Clinical Trial Compass
CompletedNot Applicable
Pediatric Concussion Assessment of Rest and Exertion
Canada456 participantsStarted 2017-03-06
Plain-language summary
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.
Who can participate
Age range10 Years – 18 Years
SexALL
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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.);
* …