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Trial registered on ANZCTR


Registration number
ACTRN12616001622493
Ethics application status
Approved
Date submitted
22/11/2016
Date registered
24/11/2016
Date last updated
30/08/2019
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Simulated Driver Rehabilitation Following Brain Injury
Scientific title
Assessing The Efficacy And Efficiency Of Simulated Driver Rehabilitation Following Acquired Brain Injury
Secondary ID [1] 290605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury
 301091 0
Stroke 301092 0
Tumor 314212 0
Condition category
Condition code
Stroke 300860 300860 0 0
Ischaemic
Stroke 300861 300861 0 0
Haemorrhagic
Neurological 300866 300866 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 296468 0
Rehabilitation
Intervention code [2] 296474 0
Treatment: Devices
Comparator / control treatment
The control group will be compose of individuals receiving treatment as standard. These 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. They will not receive the simulator rehabilitation.
Control group
Active

Outcomes
Primary outcome [1] 300272 0
Pass/fail rate of on-road occupational therapy driving assessment.
Timepoint [1] 300272 0
5 weeks post-baseline.
Primary outcome [2] 300273 0
Number of on-road driving lessons required (if initial driving assessment failed). This will be assessed by review of occupational therapy records.
Timepoint [2] 300273 0
This outcome will be assessed upon re-sitting the driving test and passing.
Secondary outcome [1] 329577 0
Driver confidence, assessed using the Day Driving Comfort Scale (Myers, Paradis & Blanchard, 2008). This is a 13 item, 5 point likert scale.
Timepoint [1] 329577 0
Pre- and post- on-road assessment
AND
Pre- and post- on-road driving lessons
Secondary outcome [2] 329578 0
Driver self-awareness, assessed using the Brain Injury Driver Self-Awareness Measure (Gooden et al., 2016). This is a 28 item measure designed to assess awareness of on-road driving performance in adults undergoing a standardised on-road driving assessment following brain injury.
Timepoint [2] 329578 0
Pre- and post- on-road assessment
AND
Pre- and post- on-road driving lessons

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

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)
Following recruitment and baseline assessment, participants will be randomized into either simulator training or no simulator training groups stratified by injury cause (TBI vs stroke). Allocation sequences will be transcribed onto cards, and placed into opaque envelopes and pass them into the Study Coordinator. Randomization lists will be separately prepared for TBI (approx. 65% of participants) and Stroke (approx. 35% of participants) patients to ensure equal numbers across strata. Staff conducting follow-up assessments will be masked to group membership and independent of treatment delivery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Standard permuted block with random block length randomization (Matthews, 2006) will be performed by a Monash-Epworth Rehabilitation Research Centre employee using a procedure such as Stata 14 ralloc (Stata Corporation, College Station, Texas, 2015).
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
Fisher’s exact test will be used to compare whether the pass/fail rate is different for standard rehabilitation only and simulator rehabilitation groups.
For those who fail the initial on-road assessment, regression methods suitable for counts, such as Poisson or negative binomial regression will be used to determine whether receiving simulator intervention predicts the number of required on-road rehabilitation sessions to complete driver rehabilitation.
Separate analyses of covariance (ANCOVAs) will be conducted to compare groups on driving confidence and driver self-awareness, adjusting for whether TBI or stroke., Stratification at randomization (TBI, Stroke) and clinically meaningful demographic and injury data will be employed as possible confounders in the ANCOVA model, conducted using (robust if indicated by the presence of skewness in the outcome variables) within a multiple regression framework. Cost-effectiveness analyses will be conducted by calculating an incremental cost-effectiveness ratio using net costs to successful completion of driving rehabilitation for each participant, as well as health effect data in the form of subjective quality of life ratings and number of weeks to return to driving.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2016
Actual
21/12/2016
Date of last participant enrolment
Anticipated
31/12/2019
Actual
13/09/2018
Date of last data collection
Anticipated
30/03/2020
Actual
20/11/2018
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6974 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [2] 6975 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 14676 0
3124 - Camberwell
Recruitment postcode(s) [2] 14677 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 295032 0
University
Name [1] 295032 0
Monash University
Country [1] 295032 0
Australia
Funding source category [2] 295033 0
Commercial sector/Industry
Name [2] 295033 0
RACV
Country [2] 295033 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk
Monash University Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 293850 0
None
Name [1] 293850 0
None
Address [1] 293850 0
None
Country [1] 293850 0
Other collaborator category [1] 279316 0
Hospital
Name [1] 279316 0
Monash Epworth Rehabilitation Research Centre
Address [1] 279316 0
Ground Floor
185-187 Hoddle Street
RICHMOND VIC 3121
Country [1] 279316 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296384 0
Epworth HealthCare Human Research Ethics Committee
Ethics committee address [1] 296384 0
Ethics committee country [1] 296384 0
Australia
Date submitted for ethics approval [1] 296384 0
14/06/2016
Approval date [1] 296384 0
12/07/2016
Ethics approval number [1] 296384 0
EH2016-39
Ethics committee name [2] 296385 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 296385 0
Ethics committee country [2] 296385 0
Australia
Date submitted for ethics approval [2] 296385 0
15/06/2016
Approval date [2] 296385 0
12/07/2016
Ethics approval number [2] 296385 0
0179

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70694 0
Prof Jennie Ponsford
Address 70694 0
School of Psychological Sciences
18 Innovation Walk
Monash University Clayton VIC 3800
Country 70694 0
Australia
Phone 70694 0
+61 3 99053058
Fax 70694 0
Email 70694 0
jennie.ponsford@monash.edu
Contact person for public queries
Name 70695 0
Bleydy Dimech-Betancourt
Address 70695 0
School of Psychological Sciences
18 Innovation Walk
Monash University Clayton VIC 3800
Country 70695 0
Australia
Phone 70695 0
+61 439257712
Fax 70695 0
Email 70695 0
bleydy.dimech-betancourt@monash.edu
Contact person for scientific queries
Name 70696 0
Bleydy Dimech-Betancourt
Address 70696 0
School of Psychological Sciences
18 Innovation Walk
Monash University Clayton VIC 3800
Country 70696 0
Australia
Phone 70696 0
+61 439257712
Fax 70696 0
Email 70696 0
bleydy.dimech-betancourt@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.