Driving Simulator Training For Adults With Acquired Brain Injuries

NCT07378592 | Recruiting

• 1 other identifier: IRB-FY2025-237
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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)

  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

  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.

  8-16 weeks

Secondary Outcomes (1)

• Behind-the-Wheel Assessment

  8-16 weeks

Study Arms (2)

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.

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.

Other: Traditional Occupational Therapy

Interventions

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.

Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention

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.

Control - Traditonal Occupational Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sacred Heart University: lead

Study Sites (1)

Sacred Heart University

Fairfield, Connecticut, 06825, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 28559646 BACKGROUND

• Dickerson 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.

  PMID: 25397762 BACKGROUND

• Ouellette 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.

  PMID: 36672036 BACKGROUND

• Classen 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.

  PMID: 23968796 BACKGROUND

• Dimech-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.

  PMID: 31597483 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Sheelagh Schlegel, DrHSc, MPH, OTR/L

  Sacred Heart University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheelagh M Schlegel, DrHSc, MPH, OTR/L

CONTACT

203 365 4773; schlegels@sacredheart.edu

Stefanie Seanor, EdD., MBA, OTR/L

CONTACT

seanors@sacredheart.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 30, 2026
• Study Start: November 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1/1/2027 - 12/31/2029
• Access Criteria: Driving Simulation researchers

Locations

US (1)