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NCT Number: NCT07378592

Driving Simulator 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.

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Key information

Conditions

Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacred Heart University

Fairfield, Connecticut, 06825, United States

Location status: Recruiting

Location contact

Sheelagh

CONTACT

[email protected]

2033654773

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Driving Simulation Intervention

Other

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

Other

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 outcomes

  1. 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)

  2. 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

  3. 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.

Secondary outcomes

  1. Behind-the-Wheel Assessment

    Time frame: 8-16 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Sheelagh M Schlegel, DrHSc, MPH, OTR/L

CONTACT

[email protected]

203 365 4773

Stefanie Seanor, EdD., MBA, OTR/L

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sacred Heart University

Other

Registry information

Official study title

Use Of Driving Simulator To Provide Pre-Driving Training For Adults With Acquired Brain Injuries.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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