Effect of Early Rest on Recovery From Pediatric Concussion

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Effect of Early Rest on Recovery From Pediatric Concussion

Conditions
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Mild Traumatic Brain Injury, Concussion, Post-concussive Syndrome

Intervention / Treatment
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* Behavioral: Mandated Rest, Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>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. | |
| Experimental: Intervention<br>Mandated Rest. | Behavioral: Mandated Rest, Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild traumatic brain injury, Concussion, postconcussive syndrome