Concussion Screen Use Recovery Time
- Conditions
- Sport-related Concussion
- Registration Number
- NCT05373992
- Lead Sponsor
- Children's Health
- 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 group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted \& exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.
- 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 patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted \& exercise group, and Control \[stretching only\]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Recovery Time Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days.
- Secondary Outcome Measures
Name Time Method Protracted recovery Greater than 30-days Secondary outcome is protracted recovery. A positive classification for protracted recovery is defined as a recovery time, as specified previously, greater than 30-days.
Trial Locations
- Locations (1)
Children's Health - Andrews Institute
🇺🇸Plano, Texas, United States
Children's Health - Andrews Institute🇺🇸Plano, Texas, United States