Clinical trial NCT04248218: Concussion Active Rehabilitation
Official title: Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric ALL
Concussion, Mild
Concussion, Brain
Concussion, Intermediate
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 55
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 care
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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.
timeFrame: 28 to 32 days post Emergency Department
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
Study officials:
References: