Recruiting

Driving Simulation Training

Sponsor:

Sacred Heart University

Code:

NCT07378592

Conditions

Acquired Brain Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Driving Simulation Intervention

Traditional Occupational Therapy

Study Details

Brief 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. 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.

Conditions

Acquired Brain Injury

Study ID

NCT07378592

Start date

Nov 15, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult participants over 18 years
  • Diagnosed acquired brain injury
  • A valid driver's license
  • History of driving prior to injury

Exclusion Criteria:

  • Age less than 18 years
  • Moderate to severe cognitive impairment, as measured on the Montreal Cognitive Assessment
  • Visual acuity or visual field issues

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention

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.

active comparator: Control - Traditonal Occupational Therapy

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.

Interventions

Driving Simulation Intervention

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 Therapy

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.

Primary outcome measure

  • Useful Field of View Assessment [ Time Frame: 8-16 weeks ]
  • Motor Free Visual Perceptual Test [ Time Frame: After 16 intervention sessions ]
  • Trails A and B assessment [ Time Frame: 8-16 weeks ]

Central Contacts and Locations

Central contacts

Sheelagh M Schlegel, DrHSc, MPH, OTR/L

203 365 4773schlegels@sacredheart.edu

Stefanie Seanor, EdD., MBA, OTR/L

seanors@sacredheart.edu

Locations

Sacred Heart University

Recruiting

Fairfield, Connecticut, United States, 06825

Contacts

More Information

Sponsor

Sacred Heart University

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Occupational Therapy
  • Pre-Driving
  • Behind-the-Wheel Assessments
  • Driving Simulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Sacred Heart University on 2026-01-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.