StrokeNCT06672107
Driver Simulator Training to Improve Driving After Stroke
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Active Driver Training Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: U.S. Veteran stroke survivors within the VA Northern California Health Care network
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
Jerry L Nadler, MD, (916) 843-2776, Jerry.Nadler@va.gov
Juliana V Baldo, PhD, (925) 372-4649, Juliana.Baldo@va.gov
About this study
Official title: Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- Active Driver Training Intervention, Control Intervention
- Keywords
- Stroke, Brain injury, Driving, Cognition
- Medical subject headings
- Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Driver Training InterventionBehavioural
Also called Active Training Intervention
simulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention
Control InterventionBehavioural
pre-scripted familiarization with driving simulator controls in the absence of any complex driving scenarios, decision making requirements, or feedback pertaining to driving skills
| Study group | Role | What they receive |
|---|---|---|
| Right hemisphere stroke | Participants with a history of a unilateral stroke affecting the right cerebral hemisphere. Receives: Behavioral: Active Driver Training Intervention; Behavioral: Control Intervention | |
| Left hemisphere stroke | Participants with a history of a unilateral stroke affecting the left cerebral hemisphere. Receives: Behavioral: Active Driver Training Intervention; Behavioral: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Score-post Active Training Intervention
Numerical score generated from the simulated Driving Assessment that takes place after the Active Driver Training intervention.
Measured: 4 weeks
Driving Score- post Control Intervention
Numerical score generated from the simulated Driving Assessment that takes place after the Control intervention.
Measured: 4 weeks
6-mo followup Driving Score
Driving Assessment after a 6-mo post-intervention delay
Measured: 6 months
Secondary outcomes (1)
Return to Driving Status-6months
Self reported return to driving status
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start17 Nov 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Krista Schendel Parker, PhD BA, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672107
- Sponsor's protocol ID
- N5300-R
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Simulator Training to Improve Driving Performance in Veteran Stroke Patients
- ClinicalTrials.gov ID
- NCT06672107
- Acronym / sponsor ID
- N5300-R
- Conditions
- Stroke
- Keywords
- Stroke, Brain injury, Driving, Cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right hemisphere stroke | – | Behavioral: Active Driver Training Intervention, Behavioral: Control InterventionParticipants with a history of a unilateral stroke affecting the right cerebral hemisphere. |
| Left hemisphere stroke | – | Behavioral: Active Driver Training Intervention, Behavioral: Control InterventionParticipants with a history of a unilateral stroke affecting the left cerebral hemisphere. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- U.S. Veteran stroke survivors within the VA Northern California Health Care network
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Driver Training InterventionAlso: Active Training Interventionsimulated driver training focusing on practice of 4 specific driving skills including lane positioning, speed management, collision avoidance, and dashboard attention | Behavioural | Left hemisphere stroke, Right hemisphere stroke |
| Control Interventionpre-scripted familiarization with driving simulator controls in the absence of any complex driving scenarios, decision making requirements, or feedback pertaining to driving skills | Behavioural | Left hemisphere stroke, Right hemisphere stroke |
Primary outcome
Driving Score-post Active Training Intervention
Time frame: 4 weeks
Numerical score generated from the simulated Driving Assessment that takes place after the Active Driver Training intervention.
Driving Score- post Control Intervention
Time frame: 4 weeks
Numerical score generated from the simulated Driving Assessment that takes place after the Control intervention.
6-mo followup Driving Score
Time frame: 6 months
Driving Assessment after a 6-mo post-intervention delay
1 secondary outcome
Return to Driving Status-6months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krista Schendel Parker, PhD BA principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krista S Parker, PhD BA ((925) 372-2513, Krista.Parker@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Score-post Active Training Intervention (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.