Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000945426p
Ethics application status
Submitted, not yet approved
Date submitted
7/08/2025
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 and feasibility of Spatialist VR gamified immersive virtual reality rehabilitation programme for patients with acquired brain injury and visuospatial neglect: Phase 2 a mixed-methods pilot study
Scientific title
Exploring the functionality and feasibility of Spatialist VR gamified immersive virtual reality rehabilitation programme for patients with acquired brain injury and visuospatial neglect: Phase 2 a mixed-methods pilot study
Secondary ID [1] 315084 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury 338480 0
visuospatial neglect 338554 0
Condition category
Condition code
Stroke 334780 334780 0 0
Haemorrhagic
Stroke 334781 334781 0 0
Ischaemic
Neurological 334858 334858 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For phase 2 the study will explore acceptability of Spatialist VR programme and feasibility of conducting a larger trail. Spatialist VR is an immersive gamified virtual reality programme that 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 and supervise from start to finish. The Spatialist VR will record participants participation. Participants will receive 5 sessions per week of 15 minutes of VR therapy for 3 weeks or until discharge.
Intervention code [1] 331695 0
Treatment: Other
Intervention code [2] 331756 0
Treatment: Devices
Comparator / control treatment
Usual therapy which consists of Occupational therapy techniques of visual scanning training with functional tasks
Control group
Active

Outcomes
Primary outcome [1] 342416 0
Acceptability of Spatialist VR
Timepoint [1] 342416 0
After three weeks of VR therapy or just prior to discharge.
Primary outcome [2] 342417 0
Feasibility of conducting a larger RCT
Timepoint [2] 342417 0
After the completion of the study
Primary outcome [3] 342418 0
Estimating sample size by reviewing the following outcomes measures to identify the most relevant and promising variables and associated MCID to calculate standard deviations: This will be assessed as a composite outcome
Timepoint [3] 342418 0
These will be completed prior to commencing the first session and after the last session within 72 hours of each timepoint.
Secondary outcome [1] 450732 0
Acceptability of Spatialist VR
Timepoint [1] 450732 0
After first session with Spatialist VR and at any point participant shows any signs of feeling unwell, during the three week intervention period within 60 minutes of using the SVR. This will include verbal reporting, change in pallor or becoming clammy.

Eligibility
Key inclusion criteria
Patients with an acquired brain injury aged equal to or older than 18 years, diagnosed visuospatial neglect.
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?
No
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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sequentially numbered sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated sequence will be prepared by hospital staff outside of the study group
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
1/10/2025
Actual
Date of last participant enrolment
Anticipated
2/03/2026
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 319657 0
Hospital
Name [1] 319657 0
Gold Coast Hospital and Health Service
Country [1] 319657 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 322157 0
None
Name [1] 322157 0
Address [1] 322157 0
Country [1] 322157 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318219 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 318219 0
Ethics committee country [1] 318219 0
Australia
Date submitted for ethics approval [1] 318219 0
16/07/2025
Approval date [1] 318219 0
Ethics approval number [1] 318219 0

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

Contacts
Principal investigator
Name 143474 0
Dr Benjamin Chen
Address 143474 0
Gold Coast University Hospital 1 Hospital Blvd Southport QLD 4215
Country 143474 0
Australia
Phone 143474 0
+61 1300 744 284
Fax 143474 0
Email 143474 0
[email protected]
Contact person for public queries
Name 143475 0
Annette McLaren-Kennedy
Address 143475 0
Robina Hospital 2 Bayberry lane Robina QLD 4226
Country 143475 0
Australia
Phone 143475 0
+61 7 56291084
Fax 143475 0
Email 143475 0
[email protected]
Contact person for scientific queries
Name 143476 0
Annette McLaren-Kennedy
Address 143476 0
Robina Hopital 2 Bayberry lane Robina QLD 4226
Country 143476 0
Australia
Phone 143476 0
+61 7 56291084
Fax 143476 0
Email 143476 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.