Acquired Brain InjuryNCT07378592
Driving Simulator Training For Adults With Acquired Brain Injuries
A study testing Driving Simulation Intervention and Traditional Occupational Therapy in people with Acquired Brain Injury, run by Sacred Heart University at 1 site in United States.
Trial summary
The aim of this project is to prepare adults with acquired brain injuries for on-road driving by using the driving simulator and increase participant's comfort level, confidence, and independence within their occupation of driving. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Driving Simulation Intervention and Traditional Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult participants over 18 years
- Diagnosed acquired brain injury
- A valid driver's license
- History of driving prior to injury
Who cannot join
- Age less than 18 years
- Moderate to severe cognitive impairment, as measured on the Montreal Cognitive Assessment
- Visual acuity or visual field issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefanie Seanor, EdD., MBA, OTR/L contact
United States1 site, 1 recruiting
- Recruiting
Sacred Heart University
Fairfield, Connecticut, 06825
Sheelagh, 2033654773, schlegels@sacredheart.edu
About this study
Official title: Use Of Driving Simulator To Provide Pre-Driving Training For Adults With Acquired Brain Injuries.
The aim of this project is to prepare adults with acquired brain injuries for on-road driving by using the driving simulator and increase participant's comfort level, confidence, and independence within their occupation of driving. The occupational therapy faculty are interested in identifying the impact driving simulation training has on individuals with acquired brain injuries and how it prepares them for on-road driving. We hope that the information from this project will help us gather information on how driving simulation training improves pre-driving skills related to comfort, confidence, and independence.
Read the detailed description
This is Phase 3 of a project that started as a capstone project in 2021 and continued with Phase 2 in 2022. . In this next phase,participants who qualify for the study will be invited to participate in the study and will be sent a consent form. They will be randomly assigned to either the driving simulator (eightsessions) or eight sessions of traditional occupational therapy as a control group. All participants will have pre- and post-testing using the same assessments. These assessments measure readiness-to-drive. All participants in the control group will be offered drivingsimulator training after completing the traditional occupational therapy sessions. All study participants will be referred to a certified driving rehabilitation specialist for behind-the-wheelassessments after completing of the driving simulation training
- Conditions
- Acquired Brain Injury
- Being tested
- Driving Simulation Intervention, Traditional Occupational Therapy
- Keywords
- Occupational Therapy, Pre-Driving, Behind-the-Wheel Assessments, Driving Simulation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Driving Simulation InterventionOther
The exercises and realistic driving scenarios on the Drive Safety R-300 simulator will enable participants to have an immersive driving experience with interactive traffic, scripted behavior models, and triggered events. The researcher will initially provide more guided feedback during the motor tasks using a series of exercises in the simulator. More difficult motor tasks will be introduced gradually. As clients' motor skills became more refined, driving practice will be introduced in diverse scenarios and environmental conditions to improve the transfer and generalizability of motor skills.
Traditional Occupational TherapyOther
Traditional occupational therapy interventions are based on typical occupational therapy assessments which assess range of motion, strength, coordination, functional mobility and self care management. Participants will receive sessions that focus on their deficits based on their acquired brain injuries. The researcher will use occupation-based interventions to improve the participants performance in functional tasks and performance in areas of occupations such as self care, leisure, play, health care management, and work.
| Study group | Role | What they receive |
|---|---|---|
| Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention | Experimental | Participants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group.
Clients in the driving simulator intervention arm will receive eight sessions in a Drive Safety R-300 driving simulator. This simulator is a partial Ford Focus cab with a full interior, standard driving controls, and instrumentation, The exercises and realistic driving scenarios on the Drive Safety R-300 simulator will enable participants to have an immersive driving experience with interactive traffic, scripted behavior models, and triggered events. The researcher will initially provide more guided feedback during the motor tasks using a series of exercises in the simulator. More difficult motor tasks will be introduced gradually. As clients' motor skills became more refined, driving practice will be introduced in diverse scenarios and environmental conditions to improve the transfer and generalizability of motor skills. Receives: Other: Driving Simulation Intervention |
| Control - Traditonal Occupational Therapy | Active comparator | Participants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group.
Participants in the control, occupational therapy group will receive interventions based on typical occupational therapy assessments which assess range of motion, strength, coordination, functional mobility and self care management. Participants will receive sessions that focus on their deficits using occupation-based interventions to improve their assessed deficits. Receives: Other: Traditional Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Useful Field of View Assessment
This is a cognitive assessment that reliably predicts crash risk in drivers. There are 3 sub tests: Processing Speed, Divided Attention, and Selective Attention, which are measured in milliseconds (ms). The 3 sub-tests contribute to an Index score which ranges from 1-5 (Very Low Risk to High Risk of vehicular crash)
Measured: 8-16 weeks
Motor Free Visual Perceptual Test
This assessment measure is meant to assess visual perception independent of motor ability. The unit of measurement is age equivalent in years and months
Measured: After 16 intervention sessions
Trails A and B assessment
This are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function. The subject is required to connect 25 encircled numbers by pencil line (Part A) and 25 alternating encircled numbers and letters (Part B) in correct order. The unit of measurement is seconds.
Measured: 8-16 weeks
Secondary outcomes (1)
Behind-the-Wheel Assessment
Participants will be referred to a certified driving rehabiliation specialist for a behind-the-wheel assessment after completing their 8 intervention sessions. The unit of measurement is Pass or Fail
Measured: 8-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start15 Nov 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sacred Heart University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheelagh Schlegel, DrHSc, MPH, OTR/L, Principal investigator, Sacred Heart University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378592
- Sponsor's protocol ID
- IRB-FY2025-237
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data on the study protocol for the driving simulation and data showing performance on the neuropsychological assessments
Publications
Blane A, Lee HC, Falkmer T, Willstrand TD. Assessing Cognitive Ability and Simulator-Based Driving Performance in Poststroke Adults. Behav Neurol. 2017;2017:1378308. doi: 10.1155/2017/1378308. Epub 2017 May 7.
PubMed 28559646Dickerson AE, Meuel DB, Ridenour CD, Cooper K. Assessment tools predicting fitness to drive in older adults: a systematic review. Am J Occup Ther. 2014 Nov-Dec;68(6):670-80. doi: 10.5014/ajot.2014.011833.
PubMed 25397762Ouellette DS, Kaplan S, Rosario ER. Back on the Road: Comparing Cognitive Assessments to Driving Simulators in Moderate to Severe Traumatic Brain Injuries. Brain Sci. 2022 Dec 28;13(1):54. doi: 10.3390/brainsci13010054.
PubMed 36672036Classen S, Wang Y, Crizzle AM, Winter SM, Lanford DN. Predicting older driver on-road performance by means of the useful field of view and trail making test part B. Am J Occup Ther. 2013 Sep-Oct;67(5):574-82. doi: 10.5014/ajot.2013.008136.
PubMed 23968796Dimech-Betancourt B, Ross PE, Ponsford JL, Charlton JL, Stolwyk RJ. The development of a simulator-based intervention to rehabilitate driving skills in people with acquired brain injury. Disabil Rehabil Assist Technol. 2021 Apr;16(3):289-300. doi: 10.1080/17483107.2019.1673835. Epub 2019 Oct 9.
PubMed 31597483
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Of Driving Simulator To Provide Pre-Driving Training For Adults With Acquired Brain Injuries.
- ClinicalTrials.gov ID
- NCT07378592
- Acronym / sponsor ID
- IRB-FY2025-237
- Conditions
- Acquired Brain Injury
- Keywords
- Occupational Therapy, Pre-Driving, Behind-the-Wheel Assessments, Driving Simulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sacred Heart UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Jan 2026 (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.
The aim of this project is to prepare adults with acquired brain injuries for on-road driving by using the driving simulator and increase participant's comfort level, confidence, and independence within their occupation of driving. The occupational therapy faculty are interested in identifying the impact driving simulation training has on individuals with acquired brain injuries and how it prepares them for on-road driving. We hope that the information from this project will help us gather information on how driving simulation training improves pre-driving skills related to comfort, confidence, and independence.
Detailed description
This is Phase 3 of a project that started as a capstone project in 2021 and continued with Phase 2 in 2022. . In this next phase,participants who qualify for the study will be invited to participate in the study and will be sent a consent form. They will be randomly assigned to either the driving simulator (eightsessions) or eight sessions of traditional occupational therapy as a control group. All participants will have pre- and post-testing using the same assessments. These assessments measure readiness-to-drive. All participants in the control group will be offered drivingsimulator training after completing the traditional occupational therapy sessions. All study participants will be referred to a certified driving rehabilitation specialist for behind-the-wheelassessments after completing of the driving simulation training
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention | Experimental | Other: Driving Simulation InterventionParticipants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group. Clients in the driving simulator intervention arm will receive eight sessions in a Drive Safety R-300 driving simulator. This simulator is a partial Ford Focus cab with a full interior, standard driving controls, and instrumentation, The exercises and realistic driving scenarios on the Drive Safety R-300 simulator will enable participants to have an immersive driving experience with interactive traffic, scripted behavior models, and triggered events. The researcher will initially provide more guided feedback during the motor tasks using a series of exercises in the simulator. More difficult motor tasks will be introduced gradually. As clients' motor skills became more refined, driving practice will be introduced in diverse scenarios and environmental conditions to improve the transfer and generalizability of motor skills. |
| Control - Traditonal Occupational Therapy | Active comparator | Other: Traditional Occupational TherapyParticipants will be randomly assigned to either the driving simulator (eight sessions) or eight sessions of traditional occupational therapy as a control group. Participants in the control, occupational therapy group will receive interventions based on typical occupational therapy assessments which assess range of motion, strength, coordination, functional mobility and self care management. Participants will receive sessions that focus on their deficits using occupation-based interventions to improve their assessed deficits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult participants over 18 years
- Diagnosed acquired brain injury
- A valid driver's license
- History of driving prior to injury
Key exclusion criteria (3 listed)
- Age less than 18 years
- Moderate to severe cognitive impairment, as measured on the Montreal Cognitive Assessment
- Visual acuity or visual field issues
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 |
|---|---|---|
| Driving Simulation InterventionThe exercises and realistic driving scenarios on the Drive Safety R-300 simulator will enable participants to have an immersive driving experience with interactive traffic, scripted behavior models, and triggered events. The researcher will initially provide more guided feedback during the motor tasks using a series of exercises in the simulator. More difficult motor tasks will be introduced gradually. As clients' motor skills became more refined, driving practice will be introduced in diverse scenarios and environmental conditions to improve the transfer and generalizability of motor skills. | Other | Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention |
| Traditional Occupational TherapyTraditional occupational therapy interventions are based on typical occupational therapy assessments which assess range of motion, strength, coordination, functional mobility and self care management. Participants will receive sessions that focus on their deficits based on their acquired brain injuries. The researcher will use occupation-based interventions to improve the participants performance in functional tasks and performance in areas of occupations such as self care, leisure, play, health care management, and work. | Other | Control - Traditonal Occupational Therapy |
Primary outcome
Useful Field of View Assessment
Time frame: 8-16 weeks
This is a cognitive assessment that reliably predicts crash risk in drivers. There are 3 sub tests: Processing Speed, Divided Attention, and Selective Attention, which are measured in milliseconds (ms). The 3 sub-tests contribute to an Index score which ranges from 1-5 (Very Low Risk to High Risk of vehicular crash)
Motor Free Visual Perceptual Test
Time frame: After 16 intervention sessions
This assessment measure is meant to assess visual perception independent of motor ability. The unit of measurement is age equivalent in years and months
Trails A and B assessment
Time frame: 8-16 weeks
This are tests of speed for attention, sequencing, mental flexibility, visual search, and motor function. The subject is required to connect 25 encircled numbers by pencil line (Part A) and 25 alternating encircled numbers and letters (Part B) in correct order. The unit of measurement is seconds.
1 secondary outcome
Behind-the-Wheel Assessment
Time frame: 8-16 weeks
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 30 Jan 2026.
- Background: PubMed 28559646Blane A, Lee HC, Falkmer T, Willstrand TD. Assessing Cognitive Ability and Simulator-Based Driving Performance in Poststroke Adults. Behav Neurol. 2017;2017:1378308. doi: 10.1155/2017/1378308. Epub 2017 May 7.
- Background: PubMed 25397762Dickerson AE, Meuel DB, Ridenour CD, Cooper K. Assessment tools predicting fitness to drive in older adults: a systematic review. Am J Occup Ther. 2014 Nov-Dec;68(6):670-80. doi: 10.5014/ajot.2014.011833.
- Background: PubMed 36672036Ouellette DS, Kaplan S, Rosario ER. Back on the Road: Comparing Cognitive Assessments to Driving Simulators in Moderate to Severe Traumatic Brain Injuries. Brain Sci. 2022 Dec 28;13(1):54. doi: 10.3390/brainsci13010054.
- Background: PubMed 23968796Classen S, Wang Y, Crizzle AM, Winter SM, Lanford DN. Predicting older driver on-road performance by means of the useful field of view and trail making test part B. Am J Occup Ther. 2013 Sep-Oct;67(5):574-82. doi: 10.5014/ajot.2013.008136.
- Background: PubMed 31597483Dimech-Betancourt B, Ross PE, Ponsford JL, Charlton JL, Stolwyk RJ. The development of a simulator-based intervention to rehabilitate driving skills in people with acquired brain injury. Disabil Rehabil Assist Technol. 2021 Apr;16(3):289-300. doi: 10.1080/17483107.2019.1673835. Epub 2019 Oct 9.
- Individual participant dataSharing planned: Yes. Data on the study protocol for the driving simulation and data showing performance on the neuropsychological assessments
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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.
Stefanie Seanor, EdD., MBA, OTR/L contact
Sheelagh Schlegel, DrHSc, MPH, OTR/L principal investigator
Sacred Heart University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Driving Simulation Intervention and Traditional Occupational Therapy in people with Acquired Brain Injury, run by Sacred Heart University 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 4 inclusion and 3 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 30 Jan 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 Sheelagh M Schlegel, DrHSc, MPH, OTR/L (203 365 4773, schlegels@sacredheart.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useful Field of View Assessment (time frame: 8-16 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?
On the ClinicalTrials.gov record for NCT07378592, which also lists 5 linked publications.
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 30 Jan 2026.