None listed
Conditions
Brief summary
This study seeks to investigate the effectiveness of simulated driver rehabilitation methods in reducing time taken and success in return to driving following an Acquired Brain Injury (ABI). No commonly agreed best-practice guidelines are currently available to guide the assessment and rehabilitation of driving ability post-ABI in Australia and worldwide. Many current driving assessment and retraining procedures used post-ABI are generic and the reliability, validity and clinical effectiveness of these procedures have yet to be established. In order to develop reliable and valid driving assessment and re-training procedures, a clear evidence-base identifying which specific driving interventions are effective post-ABI is needed. To date, studies investigating rehabilitation methods for driving post-ABI suggest that a functional, top-down approach (involving the full activity of driving a car) generalizes better than less comprehensive to improved driving performance on on-road tests. Due to modern advances in technology, production of and access to sophisticated driving simulators has increased. Given limited and inconsistent evidence surrounding the utility and effectiveness of driving simulators for rehabilitation after ABI, further exploration is warranted. In this study, participants will be recruited from the Epworth HealthCare Occupational Therapy Driving Assessment and Rehabilitation service. Their decision to participate, or not to participate, will not impact on their treatment. All participants will be involved in standard outpatient rehabilitation (as part of their regular clinical care) however participants allocated to the simulator-training group will dedicate 6 extra hours of their time (8 x 45 minute sessions) to complete the simulator program, in contrast to the standard rehabilitation group, who will not complete the program. While we do not anticipate or advocate for simulators to completely replace on-road driving rehabilitation, we propose that simulator-based training may improve pass rates for on-road assessment and reduce the total number of costly on-road rehabilitation sessions required by people returning to driving. Furthermore, simulators may act as a starting block for drivers who either lack confidence or are judged too risky to engage in on-road driving rehabilitation, and facilitate increased engagement in driving rehabilitation as a result.
Interventions
Patients who consent to and enroll in the study will be randomly allocated to one of two intervention groups: (1) A standard care rehabilitation group, and (2) A simulator training + standard care rehabilitation group.
All participants will be involved in standard outpatient rehabilitation consisting of a range of allied health therapies including physiotherapy, occupational therapy, speech pathology, psychology and neuropsychology services. In addition to standard rehabilitation, participants
Patients who consent to and enroll in the study will be randomly allocated to one of two intervention groups: (1) A standard care rehabilitation group, and (2) A simulator training + standard care rehabilitation group. All participants will be involved in standard outpatient rehabilitation consisting of a range of allied health therapies including physiotherapy, occupational therapy, speech pathology, psychology and neuropsychology services. In addition to standard rehabilitation, participants allocated into the simulator-training group will complete a program of eight 45-minute sessions (twice weekly) at Epworth Hawthorn. An occupational therapist driver assessor (OTDA) will deliver a standardised protocol, while tailoring to individual needs based on impairment (e.g. spinner knob for arm weakness due to stroke). Each session will comprise of 30 minutes driving on the simulator with 5 minutes break in between and 10 minutes of video playback of performance in order to increase awareness of errors. In order to examine the occurrence of simulator sickness in participants, the Simulator Sickness Questionnaire will be administered in sessions 1,5 and 8 (Kennedy, Lane, Berbaum, & Lilienthal, 1993). This will allow us to monitor any patient discomfort as well as identify barriers to compliance. In order to monitor adherence, a log of attendance at sessions will be taken.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Previously suffered a mild, moderate or severe stroke or traumatic brain injury; age greater than 18 years; previously held full or probationary licence; deemed by a multidisciplinary medical and allied health team that they require driving assessment; having adequate English, cognitive, visual and physical abilities to participate in driving assessment and rehabilitation; and be available to complete both simulated and on-road driving rehabilitation programs.
Exclusion criteria
Insufficient understanding of English; Less than 18 years of age; Any previous neurological condition such as MS or dementia that could impair cognition or driving behaviour with the exception of TBI and stroke; any serious condition or disorder that would preclude the individual from being referred for driving assessment as per the guidelines for assessing medical fitness to drive (e.g. severe psychiatric, neurological or physical impairments).
Outcome results
None listed