Status:
ACTIVE_NOT_RECRUITING
Mobile Subthreshold Exercise Program for Concussion--R01
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Concussion, Brain
Concussion, Mild
Eligibility:
All Genders
11-18 years
Phase:
NA
Brief Summary
Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue f...
Detailed Description
The investigators will recruit n=200 youth 11-18 years old with PPCS. Youth will be randomized to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth...
Eligibility Criteria
Inclusion
- Youth 11-18 years
- Concussion occurring 1 week to 12 months prior to the start of the study and diagnosed by a clinician trained in concussion management consistent with the 2017 Berlin consensus definition of concussion ("A traumatic brain injury, induced by biomechanical forces")
- Persistent post-concussive symptoms as defined by the presence of at least 3 concussive symptoms rated at least 2 or greater on the Health and Behavior Inventory (HBI) and a total score of at least 10
- Can be located anywhere as all study procedures are remote
Exclusion
- Youth not fluent in English or at least one Parent not fluent in English or Spanish
- Other injuries or medical conditions in addition to concussion that have prompted a clinician to recommend against MVPA, such as concerning abnormalities on routine brain imaging
- Youth who indicate that they are completing an average of 30 minutes per day or greater of physical activity that increases their heart rate (indicative of a minimal need for a physical activity intervention)
- Youth who have previously engaged with a Physical Therapist to increase aerobic activity
- Youth who have been fully cleared for sport
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04688255
Start Date
March 22 2021
End Date
October 1 2025
Last Update
May 16 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seattle Childrens Hospital
Seattle, Washington, United States, 98104