Concussion Screen Use Recovery Time

Children's Health

Status: Completed

Conditions: Sport-related Concussion

Treatments: Behavioral: Screen-time restricted plus aerobic exercise (STR+AE); Behavioral: Aerobic Exercise (AE); Behavioral: Screen Time Restriction (ST-Restricted); Behavioral: Stretching Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05373992

ABC

STU-2022-0150

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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85 participants in 4 patient groups

Screen Time Restricted

Experimental group

Description:

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Treatment:

Behavioral: Screen Time Restriction (ST-Restricted)

Aerobic Exercise

Experimental group

Description:

Participants will be asked to engage in 30-minutes of aerobic exercise (AE) 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. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Treatment:

Behavioral: Aerobic Exercise (AE)

Screen Time Restricted & Aerobic Exercise

Experimental group

Description:

Participants will be asked to limit all screen-based activities (television, smartphone, tablet, computer) as well as engage in 30-minutes of AE 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. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Treatment:

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

Stretching

Active Comparator group

Description:

Participants will be asked to follow a daily stretching program for the first 72-hours following the initial clinic visit. After the first 72-hours following the initial clinic visit, participants will follow the standard of care as prescribed by their provider. No other specific recommendations will be made to participants regarding exercise, sleep, sedentary time, or physical activity.

Treatment:

Behavioral: Stretching Only