NCT04248218

Concussion Active Rehabilitation

Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pediatric ALL
• Concussion, Mild
• Concussion, Brain
• Concussion, Intermediate

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2019-08-12
• Primary completion: 2021-01-30
• Completion: 2022-06-30
• First posted: 2020-01-30
• Last updated: 2022-08-30

Locations

1 site across 1 country: United States