ConcussionsPedCARENCT02893969
Pediatric Concussion Assessment of Rest and Exertion
A study testing Physical Activity and Rest in people with Concussions and Post-Concussive Symptoms, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Concussions, Post-Concussive Symptoms
- What is being tested?
- Physical Activity and Rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2017to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Concussions, Post-Concussive Symptoms
- Being tested
- Physical Activity, Rest
- Keywords
- Physical Activity, Rest
- Medical subject headings
- Post-Concussion Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
After 72 hours of full physical rest patients will gradually reintroduce physical activity into their daily routine.
RestBehavioural
Complete physical rest until asymptomatic.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Gradual reintroduction of non-contact physical activity at 72 hours post-concussion. Receives: Behavioral: Physical Activity |
| Control Group | Sham comparator | Physical and cognitive rest post-injury until fully asymptomatic. Once asymptomatic participants can gradually reintroduce physical activity. Receives: Behavioral: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health and Behaviour Inventory (HBI)
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
Measured: 2 weeks
Secondary outcomes (5)
Post-Concussion Symptom Inventory (PCSI)
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.
Measured: 2 and 4 weeks
The Pediatric Quality of Life Inventory™ version 4.0 (PedsQL-4.0)
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.
Measured: 2 and 4 weeks
Pediatric Injury Functional Outcome Scale (PIFOS)
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.
Measured: 2 and 4 weeks
14 days physical activity monitoring with an Actical watch z-model
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.
Measured: 2 weeks
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.
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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start6 Mar 2017
- Primary completion25 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConcussionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- The Ontario Spor Support Unit, Holland Bloorview Kids Rehabilitation Hospital, Western University, Canada, The Hospital for Sick Children, Children's Hospital of Western Ontario
- Responsible party
- Principal investigator, Roger Zemek, Children's Hospital of Eastern Ontario
- Investigators
- Roger L Zemek, MD, Principal investigator, CHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893969
- Sponsor's protocol ID
- 16/80X
- Acronym
- PedCARE
- Status last verified
- Jan 2021
- First submitted
- 2 Aug 2016
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28701360Ledoux 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.
PubMed 34836880
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02893969
- Acronym / sponsor ID
- PedCARE / 16/80X
- Conditions
- Concussions, Post-Concussive Symptoms
- Keywords
- Physical Activity, Rest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- The Ontario Spor Support Unit, Holland Bloorview Kids Rehabilitation Hospital, Western University, Canada, The Hospital for Sick Children, Children's Hospital of Western Ontario
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 25 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Physical ActivityGradual reintroduction of non-contact physical activity at 72 hours post-concussion. |
| Control Group | Sham comparator | Behavioral: RestPhysical and cognitive rest post-injury until fully asymptomatic. Once asymptomatic participants can gradually reintroduce physical activity. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical ActivityAfter 72 hours of full physical rest patients will gradually reintroduce physical activity into their daily routine. | Behavioural | Experimental group |
| RestComplete physical rest until asymptomatic. | Behavioural | Control Group |
Primary outcome
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
5 secondary outcomes
Post-Concussion Symptom Inventory (PCSI)
Time frame: 2 and 4 weeks
The Pediatric Quality of Life Inventory™ version 4.0 (PedsQL-4.0)
Time frame: 2 and 4 weeks
Pediatric Injury Functional Outcome Scale (PIFOS)
Time frame: 2 and 4 weeks
14 days physical activity monitoring with an Actical watch z-model
Time frame: 2 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Background: PubMed 28701360Ledoux 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.
- Derived from this study: PubMed 34836880Ledoux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger L Zemek, MD principal investigator
CHEO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity and Rest in people with Concussions and Post-Concussive Symptoms, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health and Behaviour Inventory (HBI) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893969, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.