Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000624684
Ethics application status
Approved
Date submitted
9/08/2005
Date registered
10/10/2005
Date last updated
10/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retraining visual processing skills to improve driving ability following acquired brain injury: a pilot study
Scientific title
Evaluation of the Dynavision 2000 light training board in retraining of visiomotor deficits in patients with acquired brain injury
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 751 0
Brain injury 752 0
Condition category
Condition code
Stroke 827 827 0 0
Neurological 828 828 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to either intervention (Dynavision training 3 times per week for 6 weeks).
Intervention code [1] 139 0
None
Comparator / control treatment
Control (Usual care, wait listed for driver retraining)
Control group
Active

Outcomes
Primary outcome [1] 1059 0
On road driving ability
Timepoint [1] 1059 0
Standard scoring protocol at week six
Secondary outcome [1] 1974 0
Abilities on: visual scanning analyser, response measures, and driving efficacy scale.
Timepoint [1] 1974 0
At six weeks.

Eligibility
Key inclusion criteria
Acquired brain injury, ability to drive has been compromised, desire to return to driving, medical clearance for driving assessment.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Physical disability which precludes participants from the use of the Dynavision or impaired learning capacity which precludes participants retraining.

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)
Sealed sequential opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator in Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 916 0
Government body
Name [1] 916 0
Motor Accident Commision, Government of South Australia
Country [1] 916 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Country
Secondary sponsor category [1] 774 0
None
Name [1] 774 0
None
Address [1] 774 0
Country [1] 774 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2200 0
Repatriation General Hospital
Ethics committee address [1] 2200 0
Ethics committee country [1] 2200 0
Date submitted for ethics approval [1] 2200 0
Approval date [1] 2200 0
Ethics approval number [1] 2200 0
Ethics committee name [2] 2201 0
Royal Adelaide Hospital
Ethics committee address [2] 2201 0
Ethics committee country [2] 2201 0
Date submitted for ethics approval [2] 2201 0
Approval date [2] 2201 0
Ethics approval number [2] 2201 0
Ethics committee name [3] 2202 0
The Queen Elizabeth Hospital
Ethics committee address [3] 2202 0
Ethics committee country [3] 2202 0
Date submitted for ethics approval [3] 2202 0
Approval date [3] 2202 0
Ethics approval number [3] 2202 0

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

Contacts
Principal investigator
Name 36141 0
Address 36141 0
Country 36141 0
Phone 36141 0
Fax 36141 0
Email 36141 0
Contact person for public queries
Name 9328 0
Prof. Maria Crotty
Address 9328 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9328 0
Australia
Phone 9328 0
+61 8 82751103
Fax 9328 0
+61 8 82751130
Email 9328 0
maria.crotty@rgh.sa.gov.au
Contact person for scientific queries
Name 256 0
Prof. Maria Crotty
Address 256 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 256 0
Australia
Phone 256 0
+61 8 82751103
Fax 256 0
+61 8 82751130
Email 256 0
maria.crotty@rgh.sa.gov.au

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.