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Trial registered on ANZCTR


Registration number
ACTRN12610000494033
Ethics application status
Approved
Date submitted
24/05/2010
Date registered
16/06/2010
Date last updated
16/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Retraining following hemianopia in acquired brain injury following stroke
Scientific title
The effects of static scanning training and mobility training on the functional mobility of people with hemianopia and/or unilateral visual neglect resulting from acquired brain injury resulting from a stroke
Secondary ID [1] 251865 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 3037 0
acquired brain injury 257501 0
hemianopia 257502 0
Condition category
Condition code
Neurological 3189 3189 0 0
Other neurological disorders
Eye 257656 257656 0 0
Diseases / disorders of the eye
Stroke 257657 257657 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One treatment arms.
Arm 1: Scanning training- 3x per week for 3 weeks, Mobility training- 3 x per week for 4 weeks. All approximately 60 minutes in duration. Scanning training uses a standardised approach to teach a pattern of systematic visual search strategies, using a Neuro Vision Tech (NVT) device. Scanning skills are graded, in mobility training, from an environment that is structured and familiar to the patient, into more dynamic busy environemnts including shopping centres. This will be performed by mobility instructors from a non-governement organisation.
Intervention code [1] 2782 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive the standard therapy intervention currently available which includes mobility training and occupational therapy intervention that promotes visual scanning and scanning training. The dosage will be recorded. This group will be wait listed for the visual scanning intervention to be offered at the completion of the six month follow up.
Control group
Active

Outcomes
Primary outcome [1] 4076 0
Mobility Assessment Course (MAC)
The MAC measures the extent to which a person visually scans and identifies hazards when walking. The MAC assesses performance on a mobility course with targets positioned on the walls along the course. Participants are scored on the number of targets they identify and the time taken to complete the course.
Timepoint [1] 4076 0
Baseline, 2, 12, 24 following randomisation.
Secondary outcome [1] 6867 0
Visual Scanning Analyser (VSA)
The VSA provides a standardized measure of the extent to which a person scans or neglects their visual fields.
Timepoint [1] 6867 0
Baseline, 2, 12, 24 weeks following randomisation.
Secondary outcome [2] 6868 0
Rivermead Behavioral Inattention Test
Rivermead Behavioral Inattention Test, is a short screening battery of tests to assess the presence and the extent of visual neglect on a sample of everyday problems faced by patients with visual inattention
Timepoint [2] 6868 0
Baseline, 2, 12, 24 weeks following randomisation
Secondary outcome [3] 6869 0
Veteran Low Vision Visual Functional Questionnaire

Mayo-Portland Adaptability Inventory

National Eye Institute Visual Functioning Questionnaire
Timepoint [3] 6869 0
Baseline, 2, 12, 24 weeks following randomisation
Secondary outcome [4] 6870 0
Peppers Visual Skills for Reading Test
Timepoint [4] 6870 0
Baseline, 2, 12, 24 weeks following randomisation

Eligibility
Key inclusion criteria
Diagnois of aquired brain injury occurring a minimum of 2 weeks and not exceeding 6 months
Left or right homonymous hemianopia
Have corrected vision of at least 6/18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Score of less than 24 on the Mini Mental State Examination
Evidence of aphasia or poor english skills that significantly impact on understanding instructions

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 consent and baseline measures particpants will be randomized.

Randomization is managed by the pharmacy department at the Repatriation General Hospital.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization is managed by the pharmacy department at the Repatriation General Hospital. A statistician external to the study will generate the random sequence using the random number generator in Microsoft Excel and created sequentially numbered, sealed envelopes containing group allocation for participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257036 0
Government body
Name [1] 257036 0
Australian Goverment National Eye Demonstration Grants Program
Country [1] 257036 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Stroke Foundation
Address
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 256295 0
Charities/Societies/Foundations
Name [1] 256295 0
Daw Park Foundation
Address [1] 256295 0
Daws Road
Daw Park
Adelaide SA 5041
Country [1] 256295 0
Australia
Other collaborator category [1] 1295 0
University
Name [1] 1295 0
Flinders University
Address [1] 1295 0
Flinders University
GPO Box 210
Adelaide SA 5001
Country [1] 1295 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259049 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 259049 0
Royal Adelaide Hospital
North Terrace
Adelaide, SA, 5000
Ethics committee country [1] 259049 0
Australia
Date submitted for ethics approval [1] 259049 0
Approval date [1] 259049 0
28/05/2008
Ethics approval number [1] 259049 0
080427
Ethics committee name [2] 259077 0
Repatriation General Hospital Research Ethics Committee
Ethics committee address [2] 259077 0
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Ethics committee country [2] 259077 0
Australia
Date submitted for ethics approval [2] 259077 0
Approval date [2] 259077 0
08/09/2008
Ethics approval number [2] 259077 0
2008071
Ethics committee name [3] 259078 0
Flinders Clinical Research Ethics Committee
Ethics committee address [3] 259078 0
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [3] 259078 0
Australia
Date submitted for ethics approval [3] 259078 0
Approval date [3] 259078 0
31/10/2007
Ethics approval number [3] 259078 0
97/200

Summary
Brief summary
Visual loss following stroke impacts significantly on activities of daily living and is an independent risk factor for becoming dependent. Routinely, allied health clinicians provide training for visual field loss, mainly with eye movement based therapy. The effectiveness of the compensatory approach to rehabilitation remains inconclusive largely due to difficulty in validating functional outcome with the varied type and dosage of therapy received by an individual patient.

This study aims to determine which treatment is more effective, a standardized dosage approach or individualized therapy in patients with homonymous hemianopia post stroke.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28520 0
Address 28520 0
Country 28520 0
Phone 28520 0
Fax 28520 0
Email 28520 0
Contact person for public queries
Name 11677 0
Stacey George
Address 11677 0
Repatriation General Hospital
Department of Rehabilitation & Aged Care
Daws Road, Daw Park, SA, 5043
Country 11677 0
Australia
Phone 11677 0
+61 8 8275 1103
Fax 11677 0
Email 11677 0
stacey.george@health.sa.gov.au
Contact person for scientific queries
Name 2605 0
Stacey George
Address 2605 0
Repatriation General Hospital
Department of Rehabilitation & Aged Care
Daws Road, Daw Park, SA, 5043
Country 2605 0
Australia
Phone 2605 0
+61 8 8275 1103
Fax 2605 0
Email 2605 0
stacey.george@health.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
SourceTitleYear of PublicationDOI
EmbaseThe effect of static scanning and mobility training on mobility in people with hemianopia after stroke: A randomized controlled trial comparing standardized versus non-standardized treatment protocols.2011https://dx.doi.org/10.1186/1471-2377-11-87
N.B. These documents automatically identified may not have been verified by the study sponsor.