Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000988459
Ethics application status
Approved
Date submitted
21/07/2016
Date registered
27/07/2016
Date last updated
27/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment for unilateral spatial neglect using eye-tracking glasses
Scientific title
For patients with a history of unilateral spatial neglect (USN) post-stroke, can eye-tracking glasses (compared to those without a history of USN) be used as an effective measure of detecting USN.
Secondary ID [1] 285605 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 293451 0
Unilateral spatial neglect (USN) 299627 0
Condition category
Condition code
Stroke 293732 293732 0 0
Ischaemic
Stroke 293733 293733 0 0
Haemorrhagic
Neurological 299585 299585 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Unilateral spatial neglect (USN) is an impaired ability to respond to sensory stimuli within the environment on the contralateral side of brain lesion location resulting from stroke. Currently USN is most commonly assessed using standard pen-and-paper tasks such as cancellations tasks, figure copying and line bisection. Despite these assessments being widely used, results have been found to often be inconsistent in detection of USN. This trial uses Tobii Pro eye-tracking glasses in the observation of inpatients with and without USN in a 10-15 minute functional task (making a hot beverage). The glasses record where the participant is looking, what they see and the patterns of their eye-tracking during the task. This will be a single 10-15 session wearing the glasses whilst making a hot beverage in a standardised therapy kitchen in a rehabilitation hospital. Additionally pen and paper tests of USN will be completed by all participants and will take a further 10-15 minutes.
Intervention code [1] 290558 0
Early Detection / Screening
Comparator / control treatment
Cohort is divided into two groups of USN and non-USN so results can be compared, however both groups have similar characteristics and are observed in the exact same assessment.
Control group
Active

Outcomes
Primary outcome [1] 293532 0
Comparison of results of eye-tracking data between patients with history USN and patients without history of USN.
Timepoint [1] 293532 0
At time of single eye-tracking assessment.
Secondary outcome [1] 311272 0
Comparison of eye-tracking results to results of validated routine pen-and-paper assessment of USN (Bells Test, Slash Line Test).
Timepoint [1] 311272 0
At time of single assessment session.

Eligibility
Key inclusion criteria
Participants will be receiving inpatient rehabilitation post-stroke at Hampstead Rehabilitation Centre; be eighteen years or older, of either gender and identified by their treating therapist to require a functional kitchen assessment within their rehabilitation program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include presentation of significant visual impairment (i.e. legally blind); hemianopia; cognitive impairment; aphasia or requiring mobility support greater that one stand by assist. Exclusions will be determined through admission medical file notes.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study aims to recruit 40 participants. Participants will be categorised into two groups (USN and non-USN) with twenty participants in each. This sample size was selected following statistician advice recommending seventeen participants for an adequately powered study. The extra three participants in each group allows for possible withdrawals. Group sample sizes of 17 and 17 achieve 80.704% power to reject the null hypothesis of equalmeans when the population mean difference is 3.0 with a standard deviation for both groups of3.0 and with a significance level (alpha) of 0.050 using a two-sided two-sample equal-variance t-test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2016
Actual
Date of last participant enrolment
Anticipated
31/07/2017
Actual
Date of last data collection
Anticipated
31/07/2017
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3126 0
Hampstead Rehabilitation Centre - Northfield
Recruitment postcode(s) [1] 8876 0
5085 - Northfield

Funding & Sponsors
Funding source category [1] 290196 0
University
Name [1] 290196 0
Flinders University
Country [1] 290196 0
Australia
Funding source category [2] 290197 0
Hospital
Name [2] 290197 0
Hampstead Rehabilitation Centre
Country [2] 290197 0
Australia
Primary sponsor type
Individual
Name
Dr Brenton Kortman
Address
Occupational Therapy, Flinders University,
Faculty of Health Sciences Building
Repatriation Hospital
Daws Road, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 288908 0
None
Name [1] 288908 0
Address [1] 288908 0
Country [1] 288908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291908 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 291908 0
Ethics committee country [1] 291908 0
Australia
Date submitted for ethics approval [1] 291908 0
19/02/2016
Approval date [1] 291908 0
22/02/2016
Ethics approval number [1] 291908 0
AU/15/85E3216

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

Contacts
Principal investigator
Name 52546 0
Dr Brenton Kortman
Address 52546 0
Occupational Therapy
Flinders University
Faculty of Health Sciences Building
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 52546 0
Australia
Phone 52546 0
+61872218287
Fax 52546 0
+61872218288
Email 52546 0
[email protected]
Contact person for public queries
Name 52547 0
Brenton Kortman
Address 52547 0
Occupational Therapy
Flinders University
Faculty of Health Sciences Building
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 52547 0
Australia
Phone 52547 0
+61872218287
Fax 52547 0
+61872218288
Email 52547 0
[email protected]
Contact person for scientific queries
Name 52548 0
Brenton Kortman
Address 52548 0
Occupational Therapy
Flinders University
Faculty of Health Sciences Building
Repatriation General Hospital
Daws Road, Daw Park SA 5041
Country 52548 0
Australia
Phone 52548 0
+61872218287
Fax 52548 0
+61872218288
Email 52548 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.