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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05373992
Study type Interventional
Source Children's Health
Contact John Abt, PhD
Phone 469-303-3000
Email John.abt@childrens.com
Status Recruiting
Phase N/A
Start date July 1, 2022
Completion date January 31, 2025

See also
  Status Clinical Trial Phase
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Completed NCT02455037 - Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion N/A
Completed NCT03883165 - How do the Neck Muscles Influence Head Acceleration During Sport-associated Impact Events in High School Athletes? N/A
Terminated NCT02257749 - Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion N/A
Completed NCT03575455 - Sub-acute Exercise Following Sport-Related Concussion N/A
Recruiting NCT02031068 - Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial N/A