Clinical trial NCT02893969: Pediatric Concussion Assessment of Rest and Exertion
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussions
Post-Concussive Symptoms
Keywords: Physical Activity
Rest
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
Collaborators: name: The Ontario Spor Support Unit
name: Holland Bloorview Kids Rehabilitation Hospital
name: Western University, Canada
name: The Hospital for Sick Children
name: Children's Hospital of Western Ontario
First posted: 2016-09-09
Enrollment: 456
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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).

Primary outcomes:
measure: Health and Behaviour Inventory (HBI)
timeFrame: 2 weeks
Secondary outcomes:
measure: Post-Concussion Symptom Inventory (PCSI)
timeFrame: 2 and 4 weeks
measure: The Pediatric Quality of Life Inventory™ version 4.0 (PedsQL-4.0)
timeFrame: 2 and 4 weeks
measure: Pediatric Injury Functional Outcome Scale (PIFOS)
timeFrame: 2 and 4 weeks
measure: 14 days physical activity monitoring with an Actical watch z-model
timeFrame: 2 weeks
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.
timeFrame: 20 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
Study officials:
affiliation: CHEO
name: Roger L Zemek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ledoux AA, Barrowman NJ, Boutis K, Davis A, Reid S, Sangha G, Farion KJ, Belanger K, Tremblay MS, Yeates KO, DeMatteo C, Reed N, Zemek R; Pediatric Emergency Research Canada PedCARE team. 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. Br J Sports Med. 2019 Feb;53(3):195. doi: 10.1136/bjsports-2017-097981. Epub 2017 Jul 12.
citation: Ledoux AA, Barrowman N, Bijelic V, Borghese MM, Davis A, Reid S, Sangha G, Yeates KO, Tremblay MS, McGahern C, Belanger K, Barnes JD, Farion KJ, DeMatteo CA, Reed N, Zemek R; PERC PedCARE Concussion team. Is early activity resumption after paediatric concussion safe and does it reduce symptom burden at 2 weeks post injury? The Pediatric Concussion Assessment of Rest and Exertion (PedCARE) multicentre randomised clinical trial. Br J Sports Med. 2022 Mar;56(5):271-278. doi: 10.1136/bjsports-2021-105030. Epub 2021 Nov 26.