Concussion Active Rehabilitation
Primary Purpose
Pediatric ALL, Concussion, Mild, Concussion, Brain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Rehabilitation Group/Case
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric ALL
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)
Sites / Locations
- Children's National Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Normal/Control
Active Rehabilitation Group/Case
Arm Description
Control Group/Standard Care
Active Rehabilitation Cohort/Intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04248218
First Posted
January 3, 2020
Last Updated
August 26, 2022
Sponsor
Children's National Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04248218
Brief Title
Concussion Active Rehabilitation
Official Title
Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 12, 2019 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric ALL, Concussion, Mild, Concussion, Brain, Concussion, Intermediate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal/Control
Arm Type
No Intervention
Arm Description
Control Group/Standard Care
Arm Title
Active Rehabilitation Group/Case
Arm Type
Active Comparator
Arm Description
Active Rehabilitation Cohort/Intervention
Intervention Type
Behavioral
Intervention Name(s)
Active Rehabilitation Group/Case
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
28 to 32 days post Emergency Department
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For the study, researchers will collect the age, gender, past medical history and through surveys, past, present and future symptoms after a head injury. This information will be used to determine which age groups are at risk and which constellation of symptoms persist following an acute head injury. All research documents and PHI will be kept in a locked cabinet and a password protected RedCap database that only study staff personnel have access to. No data will be shared until manuscript is written, but will only be shared in manuscript and not in individual data. If significant adverse data is found for a patient, the Lead PI will discuss with the subject and primary care physician.
Learn more about this trial
Concussion Active Rehabilitation
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