Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2019-08-12
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The randomization plan will include randomization based on sex.
Group A: active care Group B: routine/standard care
TREATMENT
NONE
Study Groups
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Normal/Control
Control Group/Standard Care
No interventions assigned to this group
Active Rehabilitation Group/Case
Active Rehabilitation Cohort/Intervention
Active Rehabilitation Group/Case
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.
Interventions
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Active Rehabilitation Group/Case
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.
Eligibility Criteria
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Inclusion Criteria
* Patient greater than 8 and less than 19 years old
Exclusion Criteria
* Cognitive delay
* GCS \< 14
* positive findings on head CT
* Any patient with intracranial surgery, pathology or instrumentation (e.g. VP shunt, brain tumor etc)
8 Years
18 Years
ALL
Yes
Sponsors
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Children's National Research Institute
OTHER
Responsible Party
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Jeremy Root
Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine
Locations
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Children's National Medical Center
Washington D.C., District of Columbia, United States
Countries
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Other Identifiers
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Pro0012220
Identifier Type: -
Identifier Source: org_study_id
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