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Recruiting NCT07378592

Driving Simulator Training For Adults With Acquired Brain Injuries

No phase Interventional Acquired Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Driving Simulation Intervention, Traditional Occupational Therapy.
Who it may be relevant to
Registry conditions: Acquired Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • Other 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 s
  • Other 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

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Behind-the-Wheel Assessment [Time frame: 8-16 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sacred Heart University — Fairfield

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. PMID 28559646
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07378592 · IRB-FY2025-237

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗