Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000302257
Ethics application status
Not yet submitted
Date submitted
17/03/2009
Date registered
19/05/2009
Date last updated
19/05/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Predicting driving ability after stroke in an outpatient setting (a pilot study).
Scientific title
Study of the ability of driving assessment protocols to predict driving ability in a post-stroke population.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 4487 0
Condition category
Condition code
Stroke 4766 4766 0 0
Ischaemic
Stroke 4767 4767 0 0
Haemorrhagic

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of performance on driving assessments (duration: 3 weeks): occupational therapy assessments- 2 hours, once only, one on one with the occupational therapist (OT); driving simulator test- 1 hour, once only, one on one; on road driving test- 1 hour, once only, one on one with driver OT and driving instructor.
Intervention code [1] 4236 0
Not applicable
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5631 0
"pass" result on the on road driving test (The driving results will be aggregated by principal component analysis to develop an overall Road Assessment Index. This method has been validated as a means of combining multiple independent variables into a composition score, representing overall driving performance of drivers. Pearson correlation and stepwise linear regression will be used to examine the relationships between clinical measures, off-road testing and the on-road driving ability of participants. Multivariate analysis will be employed to investigate the interacting effect of the different potentially contributing variables.
Timepoint [1] 5631 0
at point of testing
Secondary outcome [1] 241508 0
not applicable
Timepoint [1] 241508 0
not applicable

Eligibility
Key inclusion criteria
post stroke at point of return to driving
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
More than 1 year post stroke, unable to give informed consent, Mini Mental State Exam (MMSE) <22

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4676 0
Commercial sector/Industry
Name [1] 4676 0
Pfizer Neurosciences Grant
Country [1] 4676 0
Australia
Primary sponsor type
Hospital
Name
Osborne Park Hospital
Address
Osborne Place
Osborne Park
Perth WA 6021.
Country
Australia
Secondary sponsor category [1] 4222 0
None
Name [1] 4222 0
Address [1] 4222 0
Country [1] 4222 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6715 0
Ethics committee address [1] 6715 0
Ethics committee country [1] 6715 0
Date submitted for ethics approval [1] 6715 0
31/03/2009
Approval date [1] 6715 0
Ethics approval number [1] 6715 0

Summary
Brief summary
This project will examine the best way for health professionals to predict the ability of stroke survivors to safely recommence driving. Many effects of stroke can impair driving ability. Return to driving after a stroke is an important part of maintaining independence. It is therefore important that assessment of these people is readily available and accurate. Examining driving ability on the road is the ‘gold standard’ test; we will investigate what can be measured in a clinical, ‘off-road’ setting to predict safety in the ‘on-road’ test. These include: medical factors (type of stroke, position of stroke, severity of stroke etc.); impact of the stroke on driving ability (vision, concentration, memory, reasoning etc.); and ability to drive in a driving simulator (an artificial driving machine with a screen). We anticipate that we will be able to identify several tests which, alone or together, can help to predict which stroke survivors can safely return to driving.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29409 0
Address 29409 0
Country 29409 0
Phone 29409 0
Fax 29409 0
Email 29409 0
Contact person for public queries
Name 12656 0
Dr Andrew Granger
Address 12656 0
Dept of Rehabilitation and Aged care
C Block, Sir Charles Gairdner Hospital
Verdun Street
Nedlands WA 6009
Country 12656 0
Australia
Phone 12656 0
+61 8 93463333
Fax 12656 0
Email 12656 0
[email protected]
Contact person for scientific queries
Name 3584 0
Dr Andrew Granger
Address 3584 0
Dept of Rehabilitation and Aged care
C Block, Sir Charles Gairdner Hospital
Verdun Street
Nedlands WA 6009
Country 3584 0
Australia
Phone 3584 0
+61 8 93463333
Fax 3584 0
Email 3584 0
[email protected]

No information has been provided regarding IPD availability


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.