Clinical trial NCT05373992: Concussion Screen Use Recovery Time
Official title: Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sport-related Concussion
Keywords: Concussion
Sports related head injury
Lead sponsor: Children's Health
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2022-05-13
Enrollment: 85
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Recovery Time
timeFrame: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities
Secondary outcomes:
measure: Protracted recovery
timeFrame: Greater than 30-days
Other outcomes:
Locations:
city: Plano
country: United States
facility: Children's Health - Andrews Institute
state: Texas
Study officials:
References: