Status:
COMPLETED
Concussion Screen Use Recovery Time
Lead Sponsor:
Children's Health
Collaborating Sponsors:
The University of Texas Health Science Center, Houston
Conditions:
Sport-related Concussion
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control...
Detailed Description
The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patien...
Eligibility Criteria
Inclusion
- Male or female subjects
- Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
- Patients who suffered a sport-related concussion within 72-hours of first clinic visit
Exclusion
- Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
- Is not diagnosed with a SRC
- Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
- Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
- Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
- Has an increased cardiac event risk according to the American College of Sports Medicine criteria
- Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination
- Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination
- Has limited English language proficiency
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT05373992
Start Date
July 1 2022
End Date
February 1 2024
Last Update
October 18 2024
Active Locations (1)
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1
Children's Health - Andrews Institute
Plano, Texas, United States, 75024