Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-01 @ 10:32 PM
Study NCT ID:
NCT02893969
Status:
COMPLETED
Last Update Posted:
2021-01-29
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Concussion Assessment of Rest and Exertion
Sponsor:
Children's Hospital of Eastern Ontario
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PedCARE
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: