Concussion Screen Use Recovery Time

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.

Conditions

• Sport-related Concussion

Interventions

BEHAVIORAL

Screen Time Restriction (ST-Restricted)

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. Following the first 72-hours of restricted screen-time, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

BEHAVIORAL

Aerobic Exercise (AE)

Engage in 30-minutes of aerobic exercise daily for the first 72-hours following the initial clinic visit in the form of a stationary exercise bike, treadmill, or outdoors. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

BEHAVIORAL

Screen-time restricted plus aerobic exercise (STR+AE)

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) while concurrently engaging in daily aerobic exercise in the form of a stationary exercise bike, treadmill, or outdoors, for the first 72-hours following the initial clinic visit. The exercise intensity will be prescribed not to exceed 60% of the age-based maximum heart rate (HR). Following the first 72-hours of prescribed STR+AE, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

BEHAVIORAL

Stretching Only

Participants will be instructed to follow a prescribed stretching program for the first 72-hours following the initial clinic visit. Following the first 72-hours of prescribed stretching, participants will follow the standard of care until the second clinic visit at 7-days post the first clinic visit. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Children's Health

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

12 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-01

Primary Completion

2024-02-01

Completion

2024-02-01

Countries

• United States

Study Locations