Clinical trial NCT01101724: Effect of Early Rest on Recovery From Pediatric Concussion
Official title: Effect of Early Rest on Recovery From Pediatric Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Concussion
Post-concussive Syndrome
Keywords: mild traumatic brain injury
Concussion
postconcussive syndrome
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2010-04-12
Enrollment: 99
Sex: ALL
Minimum age (years): 11
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.

Detailed description: The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion. This research is being done because, currently, there is no effective treatment for concussion. Physical activity (for example; running, playing sports) and brain activity (for example; homework and tests) may make concussion symptoms worse. We are studying whether strict rest after concussion may help improve symptoms. About 110 children, ages 11-22 years old will take part in this study at the Children's Hospital of Wisconsin. This study is being funded by the Injury Research Center. The research grant pays for study procedures, follow-up testing, and patient reimbursement. Research staff is not being provided incentives to enroll subjects.

Eligibility criteria: Inclusion Criteria:

* 11-22 years
* present to the Emergency Department within 24 hours of a head injury

Exclusion Criteria:

* patients who are being admitted,
* non-English speaking patient/family,
* mental retardation (IQ \< 70)
* Suspected intoxication
* restricted used of dominant hand or limited vision
* injury or conditions affecting balance assessment
* prior mental defect or disease (e.g., developmental delay, learning disability, or moderate to severe cerebral palsy)
* known intracranial injury (e.g., intracranial bleeding, cerebral contusion)
* patients for whom a legal guardian is not present or cannot be contacted.
* ED clinician preference

Primary outcomes:
measure: Neurocognitive Outcomes
timeFrame: 10 days post injury
Secondary outcomes:
measure: Ancillary Neurocogntive Test Battery
timeFrame: 10 days
measure: Parental Attitude to Concussion:
timeFrame: 10 days
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Danny G Thomas, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sufrinko AM, Kontos AP, Apps JN, McCrea M, Hickey RW, Collins MW, Thomas DG. The Effectiveness of Prescribed Rest Depends on Initial Presentation After Concussion. J Pediatr. 2017 Jun;185:167-172. doi: 10.1016/j.jpeds.2017.02.072. Epub 2017 Mar 29.
citation: Silverberg ND, Iverson GL, McCrea M, Apps JN, Hammeke TA, Thomas DG. Activity-Related Symptom Exacerbations After Pediatric Concussion. JAMA Pediatr. 2016 Oct 1;170(10):946-953. doi: 10.1001/jamapediatrics.2016.1187.
citation: Thomas DG, Apps JN, Hoffmann RG, McCrea M, Hammeke T. Benefits of strict rest after acute concussion: a randomized controlled trial. Pediatrics. 2015 Feb;135(2):213-23. doi: 10.1542/peds.2014-0966. Epub 2015 Jan 5.