Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000254190
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
20/02/2019
Date last updated
18/05/2021
Date data sharing statement initially provided
20/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Characteristics of visual fixation in motion sensitivity
Scientific title
What are the characteristics of visual fixation in people with motion sensitivity after
vestibular insult compared to healthy adults when subjected to different visual
environments?
Secondary ID [1] 297183 0
Nil Known
Universal Trial Number (UTN)
U1111-1221-3258
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motion Sensitivity after vestibular disorder 311373 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310010 310010 0 0
Physiotherapy
Neurological 310044 310044 0 0
Other neurological disorders
Ear 310238 310238 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will attend the Motion Analysis laboratory for a single session. The session will last for 1.5 hours. The experimental set up consists of letters projected on a screen with different backgrounds with the screen 3.5 metres in front of the participant. Participants
will be standing with feet 20 cm apart on a force plate to estimate centre of pressure. Each participant will wear a mobile eye tracker device with markers attached to determine eye movements and head kinematics respectively.
This will then be repeated in a virtual reality environment. The experimental programs for lab setup and Virtual Reality environment will be developed by an engineer. For Lab programs are supported through Python and Qualysis software. For developing Virtual Reality environment UNITY will be used as game engine and C# as language of development.
Intervention will be delivered by coordinating investigator currently pursuing her doctoral degree in field of clinical sciences. She has received her Master of Physiotherapy qualification in the field of rehabilitation from India and has hands-on experience in working with people with neurological disorder. During her master's research she gained experience in conducting research adhering to clear ethical guidelines. She has also undergone consultation with the Matauranga Maori Research Committee and is familiar with the cultural considerations and the three Treaty of Waitangi principles of participation, protection and partnership.
Experimental session includes following steps:
1.Lab and technical set up prior to participant arriving
2.Static calibration procedure for 3D kinematics
3.Participant Introduction and consent process
4.Preparing participant
5.Data collection
Experimental Protocol:
There are 6 tasks, each task lasting approximately 100 seconds. The letters on the screen will appear for 7 seconds each at different position each time. Participants will be asked to focus on the letters as they appear.
Task 1: Random letters with no background: Random letters will be projected with no background.
Task 2: Random letters with busy background: Random letters will be projected on busy background.
Task 3: Multiple letters with no background: Random multiple letters will be projected on the screen. Participants
will be asked to find and focus on letter E each time.
Task 4: Multiple letters on busy background: Random multiple letters will be projected with busy background on the
screen. The participant will be asked to focus on letter E each time.
Task 5: Random letters on complex background: Random letters will be projected on a complex 2d moving
background.
Task 6: Random letters on moving background: Random letters on a moving background will be projected.
After completing the session, eye tracker glasses, markers will be taken off the participant. The study will be using moving background/moving images. In some participants there are chances of feeling of dizziness or imbalance and nausea. An assistant will be standing near the participant for any assistance and to prevent fall in case of imbalance. Appropriate rest intervals will be provided.
Intervention code [1] 313544 0
Early detection / Screening
Comparator / control treatment
Healthy Adults
Healthy participants will be tested the same way as people with motion sensitivity. They will attend the Motion Analysis laboratory for a single session and will be exposed to same experimental stimulus.
Control group
Active

Outcomes
Primary outcome [1] 318916 0
Frequency and duration of fixations in each task ;measured with eye tracker
Timepoint [1] 318916 0
During each task
Primary outcome [2] 318947 0
Centre of Pressure in each task ; measured with force plate
Timepoint [2] 318947 0
During each task
Primary outcome [3] 318952 0
Frequency of saccades in each task ; measured with eye tracker
Timepoint [3] 318952 0
During each task
Secondary outcome [1] 366522 0
Saccadic amplitude; measured with eye tracker
Timepoint [1] 366522 0
During each task
Secondary outcome [2] 366523 0
Head Kinematics; measured with Qualysis software using visual 3D
Timepoint [2] 366523 0
During each task
Secondary outcome [3] 367025 0
Saccadic average velocity; measured with eye tracker
Timepoint [3] 367025 0
During each task
Secondary outcome [4] 367026 0
Saccadic peak velocity; measured using eye tracker
Timepoint [4] 367026 0
During each task

Eligibility
Key inclusion criteria
1. Healthy adults
Participants will be included in the healthy control group if they are aged between 18-60 years with independent level of mobility. However, people having reading glasses will be included in the study, as the design of the study require focusing on a letter at a distance. Also, the size of the letter has been chosen after piloting initial work with fellow research team members.
2. Motion sensitivity after vestibular disorder
• 18-60 years of age (Agrawal, Carey et al. 2009, Bisdorff, Bosser et al. 2013)
• History of Vestibular disorder
• No signs of deficits of vestibular system
• History of motion sensitivity symptoms as reported by situational characteristics questionnaire (score >5) (Dannenbaum, Chilingaryan et al. 2011, Sharon and Hullar 2014, Silva, Ferreira et al. 2016)
• Level of dizziness as recorded by Dizziness Handicap Inventory. (Score >40)(Silva, Ferreira et al. 2016)
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History neurological conditions that could interfere with eye movements.
- History of any previous eye surgery
- Medical condition which may influence the eye movements results such as sarcoidosis, Lyme disease, diabetes mellitus.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The groups (healthy adults and people with motion sensitivity after vestibular disorder) will be compared using linear mixed modelling if normality is justified; otherwise an appropriate generalized linear mixed model will be selected on the advice of a biostatistician.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/04/2019
Actual
1/05/2019
Date of last participant enrolment
Anticipated
20/02/2020
Actual
21/02/2020
Date of last data collection
Anticipated
28/02/2020
Actual
25/02/2020
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21256 0
New Zealand
State/province [1] 21256 0
Auckland

Funding & Sponsors
Funding source category [1] 301734 0
University
Name [1] 301734 0
Auckland University of Technology
Country [1] 301734 0
New Zealand
Funding source category [2] 301880 0
Commercial sector/Industry
Name [2] 301880 0
New Zealand Dizziness and Balance Centre
Country [2] 301880 0
New Zealand
Funding source category [3] 301881 0
Government body
Name [3] 301881 0
Physiotherapy New Zealand
Country [3] 301881 0
New Zealand
Funding source category [4] 301882 0
University
Name [4] 301882 0
Eisdell Moore Centre, University of Auckland
Country [4] 301882 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 301630 0
None
Name [1] 301630 0
Address [1] 301630 0
Country [1] 301630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302459 0
Health and Disability Ethics Committee
Ethics committee address [1] 302459 0
Ethics committee country [1] 302459 0
New Zealand
Date submitted for ethics approval [1] 302459 0
04/10/2018
Approval date [1] 302459 0
02/11/2018
Ethics approval number [1] 302459 0
18/CEN/193

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

Contacts
Principal investigator
Name 90290 0
Prof Denise Taylor
Address 90290 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 90290 0
New Zealand
Phone 90290 0
+64 9 921 9680
Fax 90290 0
Email 90290 0
[email protected]
Contact person for public queries
Name 90291 0
Denise Taylor
Address 90291 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 90291 0
New Zealand
Phone 90291 0
+64 9 921 9680
Fax 90291 0
Email 90291 0
[email protected]
Contact person for scientific queries
Name 90292 0
Nicola Saywell
Address 90292 0
Health and Rehabilitation Research Institute
Faculty of Health and Environmental Science
AUT University
Private Bag 92006
Auckland 1142
Country 90292 0
New Zealand
Phone 90292 0
+64 99219502
Fax 90292 0
Email 90292 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Have not got ethical approval IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1353Study protocol    376808-(Uploaded-14-02-2019-10-48-43)-Study-related document.docx
1354Informed consent form    376808-(Uploaded-14-02-2019-10-49-19)-Study-related document.doc
1355Ethical approval    376808-(Uploaded-14-02-2019-10-49-34)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIVisual Fixations and Motion Sensitivity: Protocol for an Exploratory Study2020https://doi.org/10.2196/16805
EmbaseVisual fixations and visually induced dizziness: An exploratory study.2022https://dx.doi.org/10.1016/j.gaitpost.2022.02.002
N.B. These documents automatically identified may not have been verified by the study sponsor.