Concussion Screen Use Recovery Time

NCT05373992 | Completed

• 2 other identifiers: STU-2022-0150ABC
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Sport-related Concussion

Keywords

Concussion; Sports related head injury

Outcome Measures

Primary Outcomes (1)

• Recovery Time

  Primary outcome is recovery time (days) as measured as the number of days between the date of injury and day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities, which must occur for at least three consecutive days.

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

Secondary Outcomes (1)

• Protracted recovery

  Greater than 30-days

Study Arms (4)

Screen Time Restricted

EXPERIMENTAL

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.

Behavioral: Screen Time Restriction (ST-Restricted)

Aerobic Exercise

EXPERIMENTAL

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.

Behavioral: Aerobic Exercise (AE)

Screen Time Restricted & Aerobic Exercise

EXPERIMENTAL

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.

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

Stretching

ACTIVE COMPARATOR

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.

Behavioral: Stretching Only

Interventions

Screen Time Restriction (ST-Restricted) BEHAVIORAL

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.

Screen Time Restricted

Aerobic Exercise (AE) BEHAVIORAL

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.

Aerobic Exercise

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

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.

Screen Time Restricted & Aerobic Exercise

Stretching Only BEHAVIORAL

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.

Stretching

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Health: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Children's Health - Andrews Institute

Plano, Texas, 75024, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrews Institute Research

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 13, 2022
• Study Start: July 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 18, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)