Concussion Active Rehabilitation

Not Applicable

Completed

• Conditions: Concussion, Mild; Pediatric ALL; Concussion, Brain; Concussion, Intermediate
• Interventions: Behavioral: Active Rehabilitation Group/Case

• Registration Number: NCT04248218
• Lead Sponsor: Children's National Research Institute

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 Timeline

• Study Start: 2019-08-12
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-30
• Primary Completion: 2021-01-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-26
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Rehabilitation Group/Case	Active Rehabilitation Group/Case	Active Rehabilitation Cohort/Intervention

Primary Outcome Measures

Name	Time	Method
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.	28 to 32 days post Emergency Department	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.

Trial Locations

Locations (1)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States