Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT04248218
Brief Summary:
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:
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.
Study:
NCT04248218
Study Brief:
Protocol Section:
NCT04248218