COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted/resubmitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Retrospectively registered

Titles & IDs
Public title
Re-imagining Stroke Environments with Virtual Reality
Scientific title
Re-imagining Stroke Environments with Virtual Reality in stroke survivors
Secondary ID [1] 300514 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke rehabilitation 315697 0
Brain injury rehabilitation 315698 0
Condition category
Condition code
Stroke 313984 313984 0 0
Stroke 313985 313985 0 0

Study type
Description of intervention(s) / exposure
Cross-sectional, between-and within-subject quasi-experimental study of affective, choice preference, and physiological responses (heart rate) of stroke survivors immersed in short duration virtual reality (VR) audio-visual simulations of two types of hospital patient rooms: single and multi-patient, in context of additional physical design features i.e type of window view, spatial width, social-connectivity, night-time noise, day/night. The virtual reality kit consisting of an HTC Vive head-mounted device and Sennheiser 550A headphones, using a program of customized VR conditions using Unity software. The VR simulations are delivered once (16 Day, 16 Night scenarios) to all participants, in randomized order for each participant, by the same researcher trained in use of VR for this study. Each participant remains seated throughout the study. Each VR simulation is delivered to each participant for up to 2-3 minutes. A 20-second rest break between blocks of 5 VR scenarios is provided where the participants are asked to remain seated, with eyes closed and head still to prevent participant fatigue. All participants receive the VR exposures in one visit, or in 2 visits separated by 1 week. The decision to complete over 2 visits is based on participant fatigue, participant's availability, and availability of same testing room at the Florey Institute. The VR kit and trained researcher and participants are all located in the same testing room with no windows, with the door to the room closed, and the ambient temperature 23-25 degrees, at The Florey Institute of Neuroscience and Mental Health, Melbourne.
Intervention code [1] 316433 0
Treatment: Other
Comparator / control treatment
No control group, as all 32 VR senarios are being comapred to each other.
Control group

Primary outcome [1] 322655 0
Pick-A-Mood Scale (affective reponses)
Timepoint [1] 322655 0
Time-point 0= immediately after exposure and while participants are still immersed in the VR simulation.
Primary outcome [2] 322656 0
Visual Analogue Scale (Choice Preference responses)
Timepoint [2] 322656 0
Time-point 0=immediately after exposure and while participants are still immersed in the VR simulation.
Secondary outcome [1] 379190 0
Heart Rate (pulse probe)
Timepoint [1] 379190 0
The Heart Rate is measured following the participant's recording of their affective response on the conclusion of each VR scenario (the VAS), which occurs at 1 minute of VR exposure. The baseline heart rate is measured while participant is seated quietly prior to VR immersion for 1 minute.

Key inclusion criteria

1) >/= 18 years of age with stroke diagnosis.
2) 1 month discharged from hospital (any inpatient facility) for stroke diagnosis and up to 3 years post-stroke.
3) Admitted to any hospital ward for stroke acute care or rehabilitation minimum of 2 nights.
4) Any stroke severity using the National Institute of Health Stroke Severity scale.
5) Any functional ability.
6) Sufficient English language ability to allow Consenting.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

1) Severe cognitive or language impairments that would preclude Consenting procedures.
2) Visual and hearing loss that cannot be managed by assistive devices.
3) Severe and active mental health difficulties e.g. depression, anxiety, schizophrenia.
4) Refusal to participate in 2 visits and 1 interview.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes, to participants using central computer-generated randomized allocation to order of VR scenarios presented to participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated random sequence for each participant
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Between- and Within-group analysis using ANCOVA (with 4 main physical environment factors i.e. patient room type, noise, room size/expanse, access to outdoor view of greenery) measuring for differences in affective, physical, and preference responses to patient room types.
Regression analyses will examine for associations with patient responses with patient room type as the independent variable, and adjusting for baseline stroke severity, cognitive ability, mood status, ethnic grouping, sex, age, hospitalization for stroke frequency and duration.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 15694 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 29114 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 304597 0
Government body
Name [1] 304597 0
Address [1] 304597 0
The Centre of Research Excellence in Stroke Rehabilitation,
The Florey Institute of Neuroscience and Mental Health,
Level 1, Stroke Division,
245, Burgundy street,
Victoria 3084
Country [1] 304597 0
Primary sponsor type
The Florey Institute of Neuroscience and Mental Health, University of Melbourne
The Centre of Research Excellence in Stroke Rehabilitation,
The Florey Institute of Neuroscience and Mental Health,
Level 1, Stroke Division,
245, Burgundy street,
Victoria 3084
Secondary sponsor category [1] 304888 0
Name [1] 304888 0
Address [1] 304888 0
Country [1] 304888 0

Ethics approval
Ethics application status
Ethics committee name [1] 305019 0
Austin Health HREC
Ethics committee address [1] 305019 0
Austin Hospital,
145 Studley road,
PO Box 5555,
Victoria 3084
Ethics committee country [1] 305019 0
Date submitted for ethics approval [1] 305019 0
Approval date [1] 305019 0
Ethics approval number [1] 305019 0

Brief summary
We will recruit 60 people with stroke from 1-month post-hospital discharge to an exploratory study of patient responses to a novel virtual reality immersive experience. This VR experience is designed to compare stroke survivors’ responses to single- versus multi-patient room types according to 4 main factors i.e. social connectivity, access to nature/ greenery via window view, noise, and room size/expanse. We will gauge people’s responses using preference and emotional ratings. We will also track stroke survivors’ physical responses using a pulse probe and a wearable motion sensor. Following the 1 hour VR experience we will gather further insights into how people think and feel about patient room design. This study will run for 2 years.
On conclusion of this study, we plan to be able to show the feasibility of a VR environment testing suite in the design of physical environments for the recovery of people with stroke. We also will have identified the significance of patient room type, social connectivity, nature exposure, and room size/expanse to people with stroke. This information can then be used to inform design guidelines in Australia for new and renovated health environments in hospital and rehabilitation settings.
Trial website
Trial related presentations / publications

Public notes

Principal investigator
Name 98990 0
Prof Julie Bernhardt
Address 98990 0
The Florey Institute of Neuroscience and Mental Health,
level 1, Stroke Division,
245, Burgundy street,
Victoria 3084
Country 98990 0
Phone 98990 0
+61 0390357072
Fax 98990 0
Email 98990 0
Contact person for public queries
Name 98991 0
Ms Michelle Shannon
Address 98991 0
The Florey Institute of Neuroscience and Mental Health,
level 1, Stroke Division,
245, Burgundy street,
Victoria 3084
Country 98991 0
Phone 98991 0
+61 0410778504
Fax 98991 0
Email 98991 0
Contact person for scientific queries
Name 98992 0
Ms Michelle Shannon
Address 98992 0
The Florey Institute of Neuroscience and Mental Health,
level 1, Stroke Division,
245, Burgundy street,
Victoria 3084
Country 98992 0
Phone 98992 0
+61 0410778504
Fax 98992 0
Email 98992 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
De-identified demographic patient data, heart rate, VAS measures (discrete-choice responses), PAMS (affective categorical measure); semi-structured interviews, activity monitoring (SenseWear), code-book for quantitative analysis, code-book and tables of Codes, and Themes from qualitative analysis underlying published results.
When will data be available (start and end dates)?
Data available from the date of publication of results until 7 years post publication of results.
Available to whom?
Only to researchers who provide a sound scientific rationale for accessing this data and in consultation with primary sponsor Prof Julie Bernhardt
Available for what types of analyses?
IPD only available to answer specific aims utilizing this type of data in a scientific proposal.
How or where can data be obtained?
Data can be obtained from primary sponsor Prof julie Bernhardt email:
What supporting documents are/will be available?
No other documents available
Summary results
No Results