Concussion Active Rehabilitation
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Concussion, Brain
- Concussion, Intermediate
- Concussion Mild
- Pediatric ALL
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 careMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 8 years and 18 years
- Gender
- Both males and females
Description
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 random...
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.
Tracking Information
- NCT #
- NCT04248218
- Collaborators
- Not Provided
- Investigators
- Not Provided