CompletedNot Applicable

Concussion Screen Use Recovery Time

United States85 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recovery Time

Timeframe: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities

Trial details

NCT IDNCT05373992

SponsorChildren's Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Sport-related Concussion trials