跳至主要内容
临床试验/NCT06672107
NCT06672107招募中不适用

Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Driving Score-post Active Training Intervention

研究概览

简要总结

One hundred Veteran stroke survivors will participate in both an Active Driver Training intervention and a Control intervention in a fully interactive driving simulator. In addition, all participants will complete pre- and post-intervention driving assessments in the driving simulator to measure driving performance and types of driving errors committed. Half the participants will receive the Active Driver Training first, whereas the other half will receive the Control intervention first. Each Active Driver Training session will provide targeted practice and feedback on each of four unique driving skills including: speed management, collision avoidance, lane positioning, and dashboard attention. The Control intervention will be matched for total time but will only provide extra familiarization with the operation of the driving simulator, with no skill-specific practice. It is predicted that the Active Driver Training Intervention will result in improved driving performance, relative to the Control condition. In addition, after a delay period of at least 6 months, all participants will be re-assessed in the driving simulator and will complete a survey to capture changes in driving status.

详细描述

In this study, 100 Veteran stroke survivors (half with left hemisphere stroke and half with right hemisphere stroke) will engage in both an Active and a Control simulated driving intervention. The order of interventions (Active first vs. Control first) will be randomly assigned.

Each driving intervention will include weekly training for 3 consecutive weeks, followed by a post-intervention driving assessment. After a 1-week delay, participants will complete the other intervention type (for 3 consecutive weeks) followed by another post-intervention driving assessment. Last, all participants will be re-assessed 6 months later to measure stability of post-intervention driving performance and to complete a questionnaire on current driving status. The driving intervention condition (Active vs. Control) will serve as the main predictor variable in the study.

The Active Driver Training intervention sessions include targeted practice on four critical driving skills, namely, lane positioning, speed management, collision/obstacle avoidance, and dashboard attention. In each driver training session, participants complete all 4 modules sequentially, take a short break, and then repeat the sequence. In other words, participants receive targeted training on each skill six times over the 3-week training period.

In the Control sessions, participants will participate in familiarization drives, for a total duration comparable to the Active Driver Training sessions. The familiarization drive is a pre-programmed feature of the driving simulator that is designed to introduce/familiarize participants with the interactive features of the driving simulator (steering wheel, turn signals, rear-view mirror, etc.) but does not include any complex challenges or situations that require decision-making, and no performance feedback is given.

Simulated driving assessments will be re-administered upon completion of each intervention condition (Active Driver Training vs. Control), and again after a 6-month delay period. The driving assessments involve a challenging drive with multiple speed changes and obstacles and provides an overall score, as well as the number of driving errors committed. Post-intervention Driving Assessment scores will provide an indication of driving improvement due to intervention type, thus serving as the primary outcome variable.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • U.S. Veterans
  • History of a unilateral stroke (at least 3 months post-onset)
  • Ages 40-80
  • pre-morbidly right hand dominant
  • prior driving experience/U.S. driver's license

排除标准

  • History of other neurologic illness (e.g., TBI, dementia, epilepsy, Parkinson's, etc.)
  • History of severe psychiatric illness (e.g., schizophrenia or other psychotic disorders)
  • Recent substance abuse/dependence disorder (< 1 year)
  • Non-Veteran status

研究组 & 干预措施

Right hemisphere stroke

Participants with a history of a unilateral stroke affecting the right cerebral hemisphere.

干预措施: Active Driver Training Intervention (Behavioral)

Right hemisphere stroke

Participants with a history of a unilateral stroke affecting the right cerebral hemisphere.

干预措施: Control Intervention (Behavioral)

Left hemisphere stroke

Participants with a history of a unilateral stroke affecting the left cerebral hemisphere.

干预措施: Active Driver Training Intervention (Behavioral)

Left hemisphere stroke

Participants with a history of a unilateral stroke affecting the left cerebral hemisphere.

干预措施: Control Intervention (Behavioral)

结局指标

主要结局

Driving Score-post Active Training Intervention

时间窗: 4 weeks

Numerical score generated from the simulated Driving Assessment that takes place after the Active Driver Training intervention.

Driving Score- post Control Intervention

时间窗: 4 weeks

Numerical score generated from the simulated Driving Assessment that takes place after the Control intervention.

6-mo followup Driving Score

时间窗: 6 months

Driving Assessment after a 6-mo post-intervention delay

次要结局

  • Return to Driving Status-6months(6 months)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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