Longitudinal Assessment of Post-concussion Driving in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Road edge excursions (count)
研究概览
简要总结
Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road.
The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9.
Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery.
To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total).
This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older
- •Possesses a valid driver's license
- •1 year or more of driving experience
- •Normal or corrected-to-normal vision
- •Rostered on an organized athletic team at the college level
- •(Concussion Group Only) Diagnosed with concussion by a physician and meet inclusion criteria above.
排除标准
- •Four or more previous concussions
- •A concussion within the past 6 months
- •History of any major neurological disorders or injuries
- •Current use of any medications that evoke drowsiness (prescription or over the counter)
- •Current orthopedic condition that interferes with driving (e.g. a walking boot, shoulder immobilizer)
- •Heavy use of alcohol (binge drinking 5+ days in the past 30 days)
- •Any illegal drug use (any illegal substance use)
结局指标
主要结局
Road edge excursions (count)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of road edge excursions during a custom STISIM3 driving simulation scenario
Centerline Crossings (count)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of centerline crossings during a custom STISIM3 driving simulation scenario
Total Collisions (count)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Count of collisions during a custom STISIM3 driving simulation scenario
Standard Deviation of Lane Position (feet)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Variability of lateral lane position during a custom STISIM3 driving simulation scenario
Number of drives per day (count)
时间窗: Up to 9 days post-injury
Total number of drives per day captured as a naturalistic driving outcomes
Distance travelled per day (miles)
时间窗: Up to 9 days post-injury
Total distance driven per day captured as a naturalistic driving outcomes
Drive time per day (minutes)
时间窗: Up to 9 days post-injury
Total drive time per day captured as a naturalistic driving outcomes
Total symptom severity score
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Total sum of 0-6 ratings across 22 symptom items (SCAT6)
Visual Memory
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Visual memory domain score from CNS Vital Signs
Standard Deviation of speed (miles per hour)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Variability of driving speed during a custom STISIM3 driving simulation scenario
Verbal Memory
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Verbal memory domain score from CNS Vital Signs
Reaction Time
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Reaction time domain score from CNS Vital Signs
Complex attention
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Complex attention domain score from CNS Vital Signs
Cognitive Flexibility
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Cognitive flexibility domain score from CNS Vital Signs
Executive function
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Executive functions domain score from CNS Vital Signs
Vertical VOR Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Psychomotor Speed
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Psychomotor speed domain score from CNS Vital Signs
Processing Speed
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Processing speed domain score from CNS Vital Signs
Tandem Gait Time (seconds)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Seconds to complete the tandem gait task
Smooth Pursuit Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Balance Error Scoring System Total Error Score (count)
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Number of errors committed during the Balance Error Scoring System
Horizontal Saccades Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Convergence Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Horizontal VOR Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Visual Motion Sensitivity Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
Vertical Saccades Symptom Rating
时间窗: Within 24 hours of unrestricted medical clearance (on average <30 days post-concussion - tracked up to 1 year)
Sum of 0-10 ratings across 4 symptom items as part of Vestibulo-Ocular Motor Screening
次要结局
- Rey Osterrieth Copy Score (count)(Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- UFOV Processing Speed (ms)(Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Number of speeding events (count)(Up to 9 days post-injury)
- Hard cornering events (count)(Up to 9 days post-injury)
- Hard braking events (count)(Up to 9 days post-injury)
- Hard acceleration events (count)(Up to 9 days post-injury)
- UFOV Selective Attention (ms)(Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Pedestrian Collisions (count)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Speed exceedances (count)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Percent time over speed limit (%)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Rey Osterrieth Copy Time (sec)(Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Percent time out of lane (%)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Lateral lane position (feet)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- Speed (miles per hour)(Pre-injury baseline, day 2, day 4, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
- UFOV Divided Attention (ms)(Day 2, within 24 hours of when symptoms resolve (Asymptomatic), within 24 hours of unrestricted medical clearance)
研究者
Julianne Schmidt
Associate Professor
University of Georgia