Concussion Active Rehabilitation
Randomized Trial of Active Rehabilitation for Acute Pediatric Concussions
1 other identifier
interventional
55
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2019
CompletedFirst Submitted
Initial submission to the registry
January 3, 2020
CompletedFirst Posted
Study publicly available on registry
January 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 30, 2022
August 1, 2022
1.5 years
January 3, 2020
August 26, 2022
Conditions
Outcome Measures
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.
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
Study Arms (2)
Normal/Control
NO INTERVENTIONControl Group/Standard Care
Active Rehabilitation Group/Case
ACTIVE COMPARATORActive Rehabilitation Cohort/Intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient diagnosed with an acute concussion within 48 hours
- Patient greater than 8 and less than 19 years old
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics and Emergency Medicine, George Washington Univ School of Medicine
Study Record Dates
First Submitted
January 3, 2020
First Posted
January 30, 2020
Study Start
August 12, 2019
Primary Completion
January 30, 2021
Study Completion
June 30, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
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.