Effect of Early Rest on Recovery From Pediatric Concussion
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|ClinicalTrials.gov Identifier: NCT01101724|
Recruitment Status : Completed
First Posted : April 12, 2010
Last Update Posted : November 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mild Traumatic Brain Injury Concussion Post-concussive Syndrome||Behavioral: Mandated Rest, Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||99 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Early Rest on Recovery From Pediatric Concussion|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2012|
No Intervention: Standard of Care
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.
Behavioral: Mandated Rest, Intervention
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.
- Neurocognitive Outcomes [ Time Frame: 10 days post injury ]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.
- Ancillary Neurocogntive Test Battery [ Time Frame: 10 days ]Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days
- Parental Attitude to Concussion: [ Time Frame: 10 days ]Assess potential barriers to compliance, we will assess parental attitudes toward concussion by administering a survey to parents or caregivers during the ten day home visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101724
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53045|
|Principal Investigator:||Danny G Thomas, MD, MPH||Medical College of Wisconsin|