Pediatric Concussion Assessment of Rest and Exertion

NCT02893969 | Completed DMC

• 1 other identifier: 16/80X
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussions; Post-Concussive Symptoms

Keywords

Physical Activity; Rest

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (5)

• Post-Concussion Symptom Inventory (PCSI)

  2 and 4 weeks

• The Pediatric Quality of Life Inventory™ version 4.0 (PedsQL-4.0)

  2 and 4 weeks

• Pediatric Injury Functional Outcome Scale (PIFOS)

  2 and 4 weeks

• 14 days physical activity monitoring with an Actical watch z-model

  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.

  20 years

Study Arms (2)

Experimental group

EXPERIMENTAL

Gradual reintroduction of non-contact physical activity at 72 hours post-concussion.

Behavioral: Physical Activity

Control Group

SHAM COMPARATOR

Physical and cognitive rest post-injury until fully asymptomatic. Once asymptomatic participants can gradually reintroduce physical activity.

Behavioral: Rest

Interventions

Physical Activity BEHAVIORAL

After 72 hours of full physical rest patients will gradually reintroduce physical activity into their daily routine.

Experimental group

Rest BEHAVIORAL

Complete physical rest until asymptomatic.

Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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).

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• The Ontario Spor Support Unit: collaborator
• Holland Bloorview Kids Rehabilitation Hospital: collaborator
• Western University, Canada: collaborator
• The Hospital for Sick Children: collaborator
• Children's Hospital of Western Ontario: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Canada

Location

Related Publications (2)

• 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.

  PMID: 28701360 BACKGROUND

• 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.

  PMID: 34836880 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Motor Activity

Interventions

Exercise; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Roger L Zemek, MD

  CHEO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Dept. of Pediatrics and Emergency Medicine

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: September 9, 2016
• Study Start: March 6, 2017
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)