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The purpose of this study is to find out if strict rest for 5 days helps children get better after concussion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | 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. | |
| Intervention | Experimental | Mandated Rest. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandated Rest, Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ancillary Neurocogntive Test Battery | Assess neurocognitive outcome using a battery of neuro psych tests at 3 days and 10 days | 10 days |
| Parental Attitude to Concussion: | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danny G Thomas, MD, MPH | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28365025 | Derived | 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. | |
| 27479847 | Derived | 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. |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D038223 | Post-Concussion Syndrome |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| 10 days |
| 25560444 | Derived | 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. |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |