Concussion Active Rehabilitation

Pediatric ALL Clinical Trial

Official title:

Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248218
• Other study ID #: Pro0012220
• Status: Completed
• Phase: N/A
• Start date: August 12, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 30, 2022
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's National Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	28 to 32 days post Emergency Department