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
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Condition or disease | Intervention/treatment | Phase |
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Mild Traumatic Brain Injury Concussion Post-concussive Syndrome | Behavioral: Mandated Rest, Intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 99 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
---|---|
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.
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Experimental: Intervention
Mandated Rest.
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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.
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- 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.

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Ages Eligible for Study: | 11 Years to 22 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Danny Thomas, Assistant Professor of Pediatrics, Medical College of Wisconsin |
ClinicalTrials.gov Identifier: | NCT01101724 History of Changes |
Other Study ID Numbers: |
5520163IRC |
First Posted: | April 12, 2010 Key Record Dates |
Last Update Posted: | November 5, 2013 |
Last Verified: | November 2013 |
Keywords provided by Danny Thomas, Medical College of Wisconsin:
mild traumatic brain injury Concussion postconcussive syndrome |
Additional relevant MeSH terms:
Brain Injuries Brain Injuries, Traumatic Brain Concussion Post-Concussion Syndrome Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Head Injuries, Closed Wounds, Nonpenetrating |