Effect of Exercise and Restrictions to Screen-time on Sport-related Concussion Recovery Time Among Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Recovery Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recovery Time
时间窗: Day-1 of the participant's self-reported asymptomatic response to unrestricted physical and cognitive activities
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.
次要结局
- Protracted recovery(Greater than 30-days)
研究者
John Abt, PhD
Andrews Institute Research
Children's Health