The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12617000386336
Ethics application status
Approved
Date submitted
6/03/2017
Date registered
15/03/2017
Date last updated
15/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the most effective type of driver rehabilitation for individuals post stroke or traumatic brain injury? A comparison of driving instructor lessons and driving simulator interventions.
Scientific title
A randomised controlled trial comparing the effectiveness of two forms of driving remediation: driving lessons and driving simulation; on improving driving behaviours for individuals with stroke or traumatic brain injury.
Secondary ID [1] 291338 0
Nil known
Universal Trial Number (UTN)
U1111-1193-8864
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 302354 0
stroke 302355 0
Condition category
Condition code
Neurological 301940 301940 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 301941 301941 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will be undertaking 6 x 1 hour simulator sessions (held two times per week for 3 weeks). The intervention involves being seated in the simulator and completing training protocols focussing on areas identified as requiring driver rehabilitation including physical control of the vehicle, observation skills, vehicle positioning, speed control and planning and judgement based on the errors from the On Road assessment conducted with the occupational therapists. A protocol will be used during the training sessions; training involves following a set route that is graded in terms of performance demands and driving tasks. These tasks and scenarios encountered on the simulator will be graded in terms of environmental complexity from no or low traffic areas to increased density and visually complex environments. Each route will be directed by an occupational therapist experienced in using the simulator and this therapist will also provide teaching, instruction and feedback about performance. Cueing (such as keep to the left) and feedback provided to participants will be reduced as performance on simulator tasks of participants improve. Intervention adherence will be assessed by the occupational therapist, and strategies will include information provided regarding the direct relevance of training to deficits identified on the on road assessment.
Intervention code [1] 297395 0
Rehabilitation
Intervention code [2] 297503 0
Treatment: Devices
Intervention code [3] 297504 0
Treatment: Other
Comparator / control treatment
The control group will participate in a series of driving lessons which is currently the "usual" driving rehabilitation approach. Six times 1 hour driving lessons will be completed 2 times per week over 3 weeks with a driving instructor. The driving instructor will be experienced in working with people with neurological conditions and will be provided with the same handover as the simulator group about the driving errors and areas for driving rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 301364 0
On Road Assessment completed by an Occupational Therapist
Timepoint [1] 301364 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)
Secondary outcome [1] 332429 0
Useful Field of View Assessment
Timepoint [1] 332429 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)
Secondary outcome [2] 332431 0
Stroke Drivers Screening Assessment
Timepoint [2] 332431 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)
Secondary outcome [3] 332432 0
Adelaide Driving Self Efficacy Scale
Timepoint [3] 332432 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)
Secondary outcome [4] 332433 0
Trailmaking Test B
Timepoint [4] 332433 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)
Secondary outcome [5] 332434 0
Reaction Time test
Timepoint [5] 332434 0
Prior to randomisation (week 1) and and on conclusion of intervention (week 4)

Eligibility
Key inclusion criteria
Diagnoses of stroke or traumatic brain injury;
Meets medical guidelines to return to driving, i.e. more than one month post stroke (or equivalent duration for brain injury), binocular vision of 6/12 and appropriate visual fileds on confrontation testin,
Recommended to undertake a practical driving assessment with an Occupational Therapist
Have held a full driver's licence and driving prior to stroke/traumatic brain injury
Undertaken Occupational Therapy assessment that indicates that they would likely fail an on road assessment and require driving rehabilitation to successfully return to driving.
Minimum age
17 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Does not meet medical guidelines for driving (including visual fields of less than 120 degress with 10 degrees above and below the midline)
Experiences language difficulties that mean they cannot independently follow instructions (e.g. of driving instructor or therapist during intervention)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation via a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A minimum of 16 participants (8 per group) is required to achieve 80% power (with an alpha of 0.05) to detect change in on-road scores; based on previously collected data about on road assessment scores for individuals requiring lessons and those who successfully regained their drivers license.
Using an alpha of 0.05, multiple t-tests will be completed to determine signficant differences between each group's outcome measures at follow up assessment s. Fisher's Exact analysis will be used to determine significant differences in the pass rate and On Road Assessment scores between the groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7606 0
Repatriation Hospital - Daw Park
Recruitment postcode(s) [1] 15507 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 295810 0
University
Name [1] 295810 0
Flinders University Seeding Grant
Address [1] 295810 0
GPO Box 2100
Adelaide South Australia 5001
Country [1] 295810 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
GPO Box 2100
Adelaide South Australia 5001
Country
Australia
Secondary sponsor category [1] 294696 0
None
Name [1] 294696 0
Address [1] 294696 0
Country [1] 294696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297097 0
Southern Adelaide clinical Human Research Ethics committee
Ethics committee address [1] 297097 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia
5042
Ethics committee country [1] 297097 0
Australia
Date submitted for ethics approval [1] 297097 0
Approval date [1] 297097 0
25/01/2017
Ethics approval number [1] 297097 0
312.16

Summary
Brief summary
The study will compare the intervention of driving instructor lessons with the use of a driving
simulator to undertake driving tasks in order to identify the most effective rehabilitation approach for returning to driving post stroke or traumatic brain injury. This study will identify the most effective rehabilitation approach for returning to driving in order to inform clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72966 0
A/Prof Stacey George
Address 72966 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 72966 0
Australia
Phone 72966 0
+61 8 8275 1103
Fax 72966 0
Email 72966 0
stacey.george@flinders.edu.au
Contact person for public queries
Name 72967 0
A/Prof Stacey George
Address 72967 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 72967 0
Australia
Phone 72967 0
+61 8 275 1103
Fax 72967 0
Email 72967 0
stacey.george@flinders.edu.au
Contact person for scientific queries
Name 72968 0
A/Prof Stacey George
Address 72968 0
Rehabilitation Aged and Extended Care
Flinders University
Daws Road
Daw Park
South Australia
5041
Country 72968 0
Australia
Phone 72968 0
+61 8 8275 1103
Fax 72968 0
Email 72968 0
stacey.george@flinders.edu.au