Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000944437p
Ethics application status
Submitted, not yet approved
Date submitted
14/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the functionality of Spatialist VR gamified immersive virtual reality rehabilitation programme for healthy adults and patients with acquired brain injury and visuospatial neglect:- phase 1 alpha/beta testing.
Scientific title
Exploring the functionality of Spatialist VR gamified immersive virtual reality rehabilitation programme for healthy adults and patients with acquired brain injury and visuospatial neglect: - phase 1 alpha/beta testing
Secondary ID [1] 314879 0
None
Universal Trial Number (UTN)
Trial acronym
SVR project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Visuospatial Neglect 338159 0
Acquired brain injury 338160 0
Condition category
Condition code
Neurological 334440 334440 0 0
Other neurological disorders
Stroke 334441 334441 0 0
Haemorrhagic
Stroke 334442 334442 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1: Refine Spatialist VR programme - an immersive gamified virtual reality programme using alpha and beta testing - with the same intervention. The Spatialist VR programme enables a comprehensive assessment and targeted rehabilitation for patients with an acquired brain injury and visuospatial neglect. Participants will sit in a chair, wear a virtual reality headset and interact with the immersive gamified programme and respond to prompts using a game controller to click on specific targets. The SVR program asks participants to navigate through dynamic environments where they scan their surrounds to locate these specific targets. An Occupational Therapist will administer the intervention. This intervention will be a once off trial of the Spatialist VR lasting 15 minutes and will request participants provide feedback via
think aloud method and survey. The whole session is expected to last 45 minutes.
Alpha testing will occur first with healthy adults, followed by beta testing with individuals who are inpatients with an acquired brain injury and visuospatial neglect as assessed by their medical team. Beta testing will occur within 2 weeks of alpha testing and as stated is with the same intervention. The intervention may be refined for comfort (for example volume levels), or for technical glitches, after alpha testing before beta testing.
Intervention code [1] 331482 0
Treatment: Other
Intervention code [2] 331755 0
Treatment: Devices
Comparator / control treatment
No comparator for phase 1.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342139 0
Phase 1: to explore the acceptability to refine the SVR programme and rehabilitation procedure. This will be assessed as a composite outcome.
Timepoint [1] 342139 0
Think aloud interviews will be conducted at the time of the trial of the Spatialist VR and the Mini Player Experience Inventory questionnaire will be completed after the VR session (within the expected 45 minute session).
Secondary outcome [1] 450728 0
To evaluate the Spatialist VR rehab programme procedure
Timepoint [1] 450728 0
During the trial of the VR we will seek feedback on the procedure of using the programme

Eligibility
Key inclusion criteria
Phase 1 Adults aged equal to or older than 18 years
Score of <18 on the Motion Sickness Susceptibility Questionnaire Short-form (MSSQ)

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Reported history of conditions that may be exacerbated by VR use (e.g. epilepsy, vestibular disorders, or other health contraindications)
• Reported significant uncorrected visual impairments that would prevent use of VR
• Reported pregnancy to avoid unknown potential risks to pregnancy related to VR use
• Psychiatric or neurological conditions (e.g. psychosis or advanced dementia) that I-VR use may disrupt their sense of reality
• Severe aphasia or communication deficits as determined by research team

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2025
Actual
Date of last participant enrolment
Anticipated
2/03/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319435 0
Hospital
Name [1] 319435 0
Gold Coast Hospital and Health Service
Country [1] 319435 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 321926 0
None
Name [1] 321926 0
Address [1] 321926 0
Country [1] 321926 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318005 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 318005 0
Ethics committee country [1] 318005 0
Australia
Date submitted for ethics approval [1] 318005 0
16/07/2025
Approval date [1] 318005 0
Ethics approval number [1] 318005 0

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

Contacts
Principal investigator
Name 142854 0
Dr Benjamin Chen
Address 142854 0
Gold Coast University Hospital 1 Hospital Blvd Southport QLD 4215
Country 142854 0
Australia
Phone 142854 0
+61 1300 744 284
Fax 142854 0
Email 142854 0
[email protected]
Contact person for public queries
Name 142855 0
Annette McLaren-Kennedy
Address 142855 0
Robina Hospital 2 Bayberry lane Robina QLD 4226
Country 142855 0
Australia
Phone 142855 0
+61 7 56291084
Fax 142855 0
Email 142855 0
[email protected]
Contact person for scientific queries
Name 142856 0
Annette McLaren-Kennedy
Address 142856 0
Robina Hopital 2 Bayberry lane Robina QLD 4226
Country 142856 0
Australia
Phone 142856 0
+61 7 56291084
Fax 142856 0
Email 142856 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: .



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.