Concussion Active Rehabilitation

Study Overview
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Brief Summary
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In this study, the investigator plans a randomized trial of active rehabilitation and standard care for acute concussion management. The investigator hypothesizes that patients with acute concussions managed with active rehabilitation will have decreased risk of prolonged concussion symptoms.

Detailed Description
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Specific Aims: To compare the risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort after an acute concussion. To determine if active rehabilitation compared to routine care reduces the risk of PCS for high-risk patients. This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 8-18 years old with an acute concussion diagnosis will be eligible. All patients will receive pedometers to monitor their activity levels. If the patient is in the control group the patient will receive standard concussion management per the treating ED physician. Patients in the active rehabilitation group will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. One to five days after the ED concussion diagnosis a trained research coordinator will call all subjects to reinforce the management plan. 28 to 32 days post ED concussion diagnosis, research assistants will contact subjects via email or phone call to complete the concussion symptoms inventory.

Official Title
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Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions

Conditions
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Pediatric ALL, Concussion, Mild, Concussion, Brain, Concussion, Intermediate

Intervention / Treatment
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* Behavioral: Active Rehabilitation Group/Case


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed with an acute concussion within 48 hours Patient greater than 8 and less than 19 years old Exclusion Criteria: Major psychiatric diagnosis (bipolar disorder, major depression, does NOT include ADHD/ADD) Cognitive delay GCS < 14 positive findings on head CT Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: This is a prospective randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. The randomization plan will include randomization based on sex. Group A: active care Group B: routine/standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normal/Control<br>Control Group/Standard Care | |
| Active Comparator: Active Rehabilitation Group/Case<br>Active Rehabilitation Cohort/Intervention | Behavioral: Active Rehabilitation Group/Case<br>* If the patient is in the active rehabilitation group, the patient will receive instructions based on the latest CDC concussion management guidelines that specify a symptom-limited progressive return to full activities. This group will be instructed to take at least 10,000 steps a day for five days on their pedometers. In addition, they will also watch a two-minute video by the PI and research team reinforcing the active rehabilitation instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will measure and compare the relative risk of prolonged concussion symptoms (PCS) between an active rehabilitation and a standard care cohort one month after an acute concussion. | We hypothesize that subjects managed with active rehabilitation post an acute concussion will have a 20% decreased relative risk of PCS compared to those managed with standard care. | 28 to 32 days post Emergency Department |