Driver Simulator Training to Improve Driving After Stroke

Официальное название

Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Active Driver Training Intervention
  simulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention
• Поведенческое Control Intervention
  pre-scripted familiarization with driving simulator controls in the absence of any complex driving scenarios, decision making requirements, or feedback pertaining to driving skills

Первичные конечные точки

• Driving Score-post Active Training Intervention [Срок оценки: 4 weeks]
• Driving Score- post Control Intervention [Срок оценки: 4 weeks]
• 6-mo followup Driving Score [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Return to Driving Status-6months [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-кроссовер

Центры проведения

США · 1 центр

• VA Northern California Health Care System, Mather, CA — Sacramento

Идентификаторы

NCT: NCT06672107 · N5300-R

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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