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Driving Simulator Training For Adults With Acquired Brain Injuries

S

Sacred Heart University

Status

Enrolling

Conditions

Acquired Brain Injury

Treatments

Other: Traditional Occupational Therapy
Other: Driving Simulation Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07378592
IRB-FY2025-237

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Driving Simulator or Traditional Occupational Therapy as Pre-Driving intervention
Experimental group
Description:
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.
Treatment:
Other: Driving Simulation Intervention
Control - Traditonal Occupational Therapy
Active Comparator group
Description:
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.
Treatment:
Other: Traditional Occupational Therapy

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Stefanie Seanor, EdD., MBA, OTR/L; Sheelagh M Schlegel, DrHSc, MPH, OTR/L

Data sourced from clinicaltrials.gov

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