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Completed

NCT Number: NCT04248218

Concussion Active Rehabilitation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active Rehabilitation Group/Case

Behavioral

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.

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's National Research Institute

Other

Registry information

Official study title

Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 30, 2020
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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