The Effects of Environmental Distractions on SCAT6 Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Significant association between visual and auditory distractions and the outcomes of the Standardized Concussion Assessment Tool (SCAT6) assessment
研究概览
简要总结
The purpose of this study is to assess the effects of visual and auditory distractions on SCAT5 scores. The study is designed to identify the effects of about 80 participants completing the SCAT5 in college-aged athletes. All participants will perform the same tasks in two settings (distracted and non-distracted). The central hypothesis is that there will be a significant association between distractions and a lower score on the SCAT5. The cognitive screening, neurological screen, and mBESS should showcase a decrease scores during the distracted environment.
详细描述
The researchers will use a randomized controlled trial design and recruit participants on a first-come, first-serve basis for the study. This crossover design will consist of two groups. The two groups are; distracted and non-distracted. The study will consist of two time points in an 8-day period.
After the initial recruitment email and enrollment questionnaire, those who are eligible for the study will be randomly assigned to begin in one of the two groups. The researchers will include a self-reported health questionnaire to obtain demographic information. The information includes age, sex, race/ ethnicity, years of athletic experience, number of previous concussions, favorite sports (with gender and level) to watch, and an assessment of other neurological conditions to screen participants' eligibility. Participants who meet the inclusion criteria and are free of exclusionary factors will advance to the consent forms and testing procedures. Consent forms will be filled out via Qualtrics.
Symptom Evaluation:
The symptom evaluation assesses severity and presence of symptoms. The symptom evaluation requires participants to self-report a total of 22 on a 7-point Likert scale ranging from 0 (none) to 7 (severe). Participants will be instructed to truthfully report their symptoms by circling their scores. Symptom scores will be manually transferred to an Excel spreadsheet for future analyses.
Cognitive Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous athletic experience beginning at or after the age of 12
排除标准
- •Diagnosed with a neurological condition (including epilepsy, stroke, seizures)
- •Have had a concussion within the past 6 months (diagnosed or undiagnosed)
- •have not participated in sport
结局指标
主要结局
Significant association between visual and auditory distractions and the outcomes of the Standardized Concussion Assessment Tool (SCAT6) assessment
时间窗: Completion of both environments to analyze the differences in scores will be completed on day 8.
Scores on the SCAT6 will differ between the control and non-distracted environment. Specifically for the main portion of the SCAT6 the orientation, immediate memory, concentration, and delayed recall scores will be compiled. Scores can be a minimum of 0 and a maximum of 50. A higher score indicates better performance while a lower score indicates worse performance.
次要结局
- Modified Balance Error Scoring System (mBESS)(Completion of both environments to analyze the differences in scores will be completed on day 8.)
- Symptom list(Completion of both environments to analyze the differences in scores will be completed on day 8.)
研究者
Keisuke Kawata
Associate Professor
Indiana University