Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000375954
Ethics application status
Approved
Date submitted
2/02/2020
Date registered
17/03/2020
Date last updated
8/11/2021
Date data sharing statement initially provided
17/03/2020
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)
None
Trial acronym
RiSE-VR
Linked study record
None

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
Ischaemic
Stroke 313985 313985 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
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
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Escalation of Covid 19 Pandemic
Date of first participant enrolment
Anticipated
Actual
9/04/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
13/03/2020
Date of last data collection
Anticipated
30/06/2020
Actual
13/03/2020
Sample size
Target
60
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15694 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 21045 0
Epworth Richmond - Richmond
Recruitment postcode(s) [1] 29114 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 35885 0
3121 - Richmond
Recruitment postcode(s) [3] 35886 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 304597 0
Government body
Name [1] 304597 0
NHMRC
Country [1] 304597 0
Australia
Primary sponsor type
University
Name
The Florey Institute of Neuroscience and Mental Health, University of Melbourne
Address
The Centre of Research Excellence in Stroke Rehabilitation,
The Florey Institute of Neuroscience and Mental Health,
Level 1, Stroke Division,
245, Burgundy street,
Heidelberg,
Victoria 3084
Country
Australia
Secondary sponsor category [1] 304888 0
None
Name [1] 304888 0
Address [1] 304888 0
Country [1] 304888 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305019 0
Austin Health HREC
Ethics committee address [1] 305019 0
Ethics committee country [1] 305019 0
Australia
Date submitted for ethics approval [1] 305019 0
25/07/2018
Approval date [1] 305019 0
23/08/2018
Ethics approval number [1] 305019 0
HREC/18/Austin/272

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

Contacts
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,
Heidelberg,
Victoria 3084
Country 98990 0
Australia
Phone 98990 0
+61 0390357072
Fax 98990 0
Email 98990 0
j.bernhardt@unimelb.edu.au
Contact person for public queries
Name 98991 0
Michelle Shannon
Address 98991 0
The Florey Institute of Neuroscience and Mental Health,
level 1, Stroke Division,
245, Burgundy street,
Heidelberg,
Victoria 3084
Country 98991 0
Australia
Phone 98991 0
+61 0410778504
Fax 98991 0
Email 98991 0
mshannon1@student.unimelb.edu.au
Contact person for scientific queries
Name 98992 0
Michelle Shannon
Address 98992 0
The Florey Institute of Neuroscience and Mental Health,
level 1, Stroke Division,
245, Burgundy street,
Heidelberg,
Victoria 3084
Country 98992 0
Australia
Phone 98992 0
+61 0410778504
Fax 98992 0
Email 98992 0
mshannon1@student.unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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: julie.bernhardt@florey.edu.au


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.