Trial Review

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


Registration number
ACTRN12605000122651
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
10/08/2005
Date last updated
10/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Validation of a driving efficacy scale
Scientific title
Validation of a driving efficacy scale with normal and stroke populations
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 210 0
Condition category
Condition code
Stroke 235 235 0 0

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 142 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 281 0
Efficacy Scale Score - total and individual items
Timepoint [1] 281 0
Secondary outcome [1] 626 0
None.
Timepoint [1] 626 0

Eligibility
Key inclusion criteria
Normal population - people who have not had a stroke who are currently driving. Stroke population - people who have had a stroke who are currently driving.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 295 0
Self funded/Unfunded
Name [1] 295 0
Country [1] 295 0
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 228 0
None
Name [1] 228 0
None
Address [1] 228 0
Country [1] 228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1159 0
Repatriation General Hospital
Ethics committee address [1] 1159 0
Ethics committee country [1] 1159 0
Australia
Date submitted for ethics approval [1] 1159 0
Approval date [1] 1159 0
Ethics approval number [1] 1159 0
Ethics committee name [2] 1160 0
Royal Adelaide Hospital
Ethics committee address [2] 1160 0
Ethics committee country [2] 1160 0
Australia
Date submitted for ethics approval [2] 1160 0
Approval date [2] 1160 0
Ethics approval number [2] 1160 0
Ethics committee name [3] 1161 0
Flinders University/Flinders Medical Centre
Ethics committee address [3] 1161 0
Ethics committee country [3] 1161 0
Australia
Date submitted for ethics approval [3] 1161 0
Approval date [3] 1161 0
Ethics approval number [3] 1161 0

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

Contacts
Principal investigator
Name 36376 0
Address 36376 0
Country 36376 0
Phone 36376 0
Fax 36376 0
Email 36376 0
Contact person for public queries
Name 9331 0
Prof. Maria Crotty
Address 9331 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9331 0
Australia
Phone 9331 0
+61 8 82751103
Fax 9331 0
+61 8 82751130
Email 9331 0
[email protected]
Contact person for scientific queries
Name 259 0
Prof. Maria Crotty
Address 259 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 259 0
Australia
Phone 259 0
+61 8 82751103
Fax 259 0
+61 8 82751130
Email 259 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.