Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000284662p
Ethics application status
Submitted, not yet approved
Date submitted
1/03/2023
Date registered
16/03/2023
Date last updated
16/03/2023
Date data sharing statement initially provided
16/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Immersive virtual reality in residential aged care: mixed-methods study
Scientific title
Physical rehabilitation for people without cognitive impairment living in residential aged care: mixed-methods study investigating the impact of immersive virtual reality on motivation to engage in physical activity
Secondary ID [1] 309101 0
Nil
Universal Trial Number (UTN)
U1111-1289-1473
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical rehabilitation 329184 0
Physical inactivity 329279 0
Condition category
Condition code
Physical Medicine / Rehabilitation 326149 326149 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Care staff, led by a physiotherapist, will implement a six-week group program of immersive virtual reality physical activities for participating residents. The training will be provided by RecoveryVR in a workshop format provided face-to-face over two hours.

After the training session, staff will deliver the virtual reality activities which will involve:
1. Orientation session: The two initial 30-40 minute sessions will enable each resident to trial the Pico Neo 3 head-mounted virtual reality display, hand controller, immersive virtual reality experience and a 5-10 minute sample of the physical activities in the program. Residents will have the opportunity to affirm or withdraw their consent to participate in the study. Residents and staff will be observed during this session and will participate in separate reflexive focus group discussions on conclusion to capture responses to the experience of virtual reality, the physical activities and the group session. The service manager will also be interviewed about the program.
2. Virtual reality physical activity program: The program will comprise of 30-40 minute group sessions each week for the subsequent five weeks during which participating residents will each take part in at least one 5-10 minute block of immersive virtual reality physical activities. Residents will be seated and will primarily use the upper extremities. This will be undertaken in two successive groups of five residents. The residents’ view will be streamed onto a monitor so staff can provide support. Residents and staff will be observed and will participate in separate focus groups after each weekly session to reflect on their experience. The physiotherapist will also be interviewed briefly each week.
3. On conclusion of the six-week program: Participants will be interviewed individually using open-ended questions to collect reactions to the program’s content, conduct and therapeutic value, and reflections on the use of immersive virtual reality technology in residential aged care.

The virtual reality activities in this study are games and exercises that promote physical activity. They are designed to be accessible and fun. The scenarios will be selected from the following activities:
• Games
o Upper body - a range of games designed to use the participant’s existing range of motion, reach, and response time.
o Sport - popular ball sports that involves trunk rotation and sit-to-stand
o Balance - activities that require trunk strength, sitting and standing balance.
• Exercise
o Trail - videos from various locations that require task specific repetition to play.
o Waterway - row, kayak through these videos that requires upper body strength and general endurance.
o Gym - use these gym applications to increase strength and upper limb function Stretching - follow along with these videos to stretch out different parts of the body.
• Creative
o Painting - paint a masterpiece in 3D to increase time on task and includes upper limb range of motion, reach and grasp.
o Building - build your own toy town that uses trunk rotation and reach.

Adherence will be monitored using a piloted worksheet at each session and include time using the virtual reality, problems with the technology, and time take for potential troubleshooting.
Intervention code [1] 325548 0
Rehabilitation
Intervention code [2] 325549 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334022 0
Intrinsic Motivation Inventory - This tool assesses the subjective experiences of the target activities in line with components of Self Determination Theory.
Timepoint [1] 334022 0
Weekly from Week 1 to Week 6 of the group program
Secondary outcome [1] 419119 0
User Satisfaction Evaluation Questionnaire
Timepoint [1] 419119 0
Weekly from Week 1 to Week 6 of the group program
Secondary outcome [2] 419120 0
Exploration of participant experiences and their feedback will be conducted in separate semi-structured focus groups each week and analysed by reflexive thematic analysis. A member of the research team will conduct each focus group.
Timepoint [2] 419120 0
Weekly from Week 1 to Week 6 of the group program
Secondary outcome [3] 419425 0
Exploration of staff experiences and their feedback will be conducted in separate semi-structured focus groups each week and analysed by reflexive thematic analysis. A member of the research team will conduct each focus group.
Timepoint [3] 419425 0
Weekly from Week 1 to Week 6 of the group program

Eligibility
Key inclusion criteria
Residents: Not experiencing cognitive impairment, assessed by staff as being suitable to participate, assessed by physiotherapist to be capable of undertaking the virtual reality physical activities.

Staff: Qualified physiotherapist, allied health professionals and other support staff (e.g. lifestyle managers).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Residents: Person living with cognitive impairment or dementia.

Staff: Staff not involved with the intervention.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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
27/03/2023
Actual
Date of last participant enrolment
Anticipated
10/04/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 39691 0
2620 - Queanbeyan

Funding & Sponsors
Funding source category [1] 313304 0
University
Name [1] 313304 0
University of Canberra
Country [1] 313304 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 315055 0
None
Name [1] 315055 0
Address [1] 315055 0
Country [1] 315055 0
Other collaborator category [1] 282575 0
Commercial sector/Industry
Name [1] 282575 0
Warrigal Care
Address [1] 282575 0
50 Canberra Ave
Queanbeyan NSW 2620
Country [1] 282575 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312530 0
University of Canberra Human Research Committee
Ethics committee address [1] 312530 0
Ethics committee country [1] 312530 0
Australia
Date submitted for ethics approval [1] 312530 0
23/11/2022
Approval date [1] 312530 0
Ethics approval number [1] 312530 0

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

Contacts
Principal investigator
Name 124990 0
Dr Nathan M D'Cunha
Address 124990 0
University of Canberra Hospital
20 Guraguma St
Bruce ACT 2617
Country 124990 0
Australia
Phone 124990 0
+61 2 6206 8585
Fax 124990 0
Email 124990 0
[email protected]
Contact person for public queries
Name 124991 0
Nathan M D'Cunha
Address 124991 0
University of Canberra Hospital
20 Guraguma St
Bruce ACT 2617
Country 124991 0
Australia
Phone 124991 0
+61 2 6206 8585
Fax 124991 0
Email 124991 0
[email protected]
Contact person for scientific queries
Name 124992 0
Nathan M D'Cunha
Address 124992 0
University of Canberra Hospital
20 Guraguma St
Bruce ACT 2617
Country 124992 0
Australia
Phone 124992 0
+61 2 6206 8585
Fax 124992 0
Email 124992 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
Ethics application does not request permission for data sharing.


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.