Concussion Active Rehabilitation

• Sponsor: Children's National Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04248218
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 34.6
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric ALL; Concussion, Mild; Concussion, Brain; Concussion, Intermediate	Behavioral: Active Rehabilitation Group/Case	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 careThis 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
• Actual Study Start Date: Aug 12, 2019
• Actual Primary Completion Date: Jan 30, 2021
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Normal/Control Control Group/Standard Care
Active Comparator: Active Rehabilitation Group/Case Active Rehabilitation Cohort/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.

Outcome Measures

Primary Outcome Measures

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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's National Medical Center	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• Children's National Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jeremy Root, Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine, Children's National Research Institute
• ClinicalTrials.gov Identifier: NCT04248218
• Other Study ID Numbers: Pro0012220
• First Posted: Jan 30, 2020
• Last Update Posted: Mar 7, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Concussion

Study Results

No Results Posted as of Mar 7, 2022