NCT01101724|CompletedDMC
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Sponsor study identifier
interventional
99
1 country
1
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2012
Actual (reported)The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 8, 2010
Actual (reported)April 12, 2010
Actual (reported)December 2011
Actual (reported)December 2012
Actual (reported)Neurocognitive Outcomes
Neurocogntive outcomes assessed using computer-based neurocogntive testing based on changes from scores obtained in the emergency department to scores obtained at 3 days and 10 days.
10 days post injury
Ancillary Neurocogntive Test Battery
10 days
Parental Attitude to Concussion:
10 days
In this group, the treating attending physician will be free to make rest recommendations as they see fit. An internal survey of physician practice found that the vast majority of physicians instruct patients rest for 1-2 days, then to return to school and physical activity after the patient's symptoms have resolved. The amount of rest will vary from patients to patient based on variation in symptom resolution and patient compliance. This advice is consistent with best practices outlined by the CDC.
Mandated Rest.
In addition to CDC based discharge instructions, the intervention group will receive instructions with strict activity restriction explicitly stating "No return to school" and "No Physical Activity" for the next five days. Patients and parents in the intervention group will be provided school and work excuses for the five days post-injury.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53045, United States
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.
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.
Danny G Thomas, MD, MPH
Medical College of Wisconsin
99 participants (actual enrollment reported by the registry).
First Submitted
April 8, 2010
First Posted
April 12, 2010
Study Start
April 2010
Date type not reportedThis date has not been verified as actual or estimated.
Cortical Plasticity Assessment in Athletes With a History of Concussion
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2012
Actual (reported)Last Updated
November 5, 2013
Record last verified: 2013-11
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Source: ClinicalTrials.gov.
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