Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000702516
Ethics application status
Approved
Date submitted
14/05/2024
Date registered
4/06/2024
Date last updated
4/06/2024
Date data sharing statement initially provided
4/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Adapting Off-the-Shelf Games to Serve as Useful Games in the Process of Post Stroke Upper Limb Rehabilitation
Scientific title
The Impact of Adapted Off-the-Shelf Virtual Reality (VR) Games on Upper Limb Function in Post-Stroke Rehabilitation
Secondary ID [1] 311865 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 333414 0
Upper Limb Hemiparesis 333415 0
Condition category
Condition code
Stroke 330092 330092 0 0
Haemorrhagic
Stroke 330093 330093 0 0
Ischaemic
Physical Medicine / Rehabilitation 330602 330602 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial focuses on how 'off-the-shelf' virtual reality games for the Meta Quest 2 VR headset can be adapted to improve upper limb outcomes post stroke. The goal is to use these adapted games and the virtual reality system to supplement regular therapy hours to hopefully improve upper limb outcomes post stroke. Furthermore, a protocol will likely be developed that can make these findings easily reproducible in other settings that are focussed on upper limb stroke rehabilitation.
Participants will be required to take part in a 6 week program, in which the first 2 weeks will be baseline, second two weeks will include the intervention, and the last 2 weeks will be baseline again.
During the intervention phase, participants will be required to play adapted games on the VR headset for an hour each weekday along with their regular physiotherapy sessions. This will equate to 10 hours over the two week intervention phase.
During baseline, participants will continue their regular physiotherapy with no VR intervention.
Mode of delivery will be face to face an individually with one participant at a time.
The intervention will be delivered by a 4th year Occupational Therapy student as part of their research honours. They will be supervised by a neurological physiotherapist with many years of clinical and research training in stroke recovery at all times.
Intervention will be delivered at a Medical Clinic in the Rehabilitation Gym.
The purpose of this study is to see how these games can be adaptable and suitable for different levels of stroke impairment. Therefore, the games will be personalised for each participant depending on where they are in their rehabilitation journey. One example of an adapted game is Beat Saber, which involves slicing blocks in a timely manner as they fly towards you. Another example is Cubism, which involves using fine motor skills to manipulate puzzle pieces and solve puzzles. Some examples of adaptations in these games include the types of games played, speed of games, complexity, number of task demands, overall difficulty, fine motor/gross motor requirements, and periods for which games will be played without rest. For example, Beat Saber may be adapted to run at a slower pace, with a reduce number of blocks, or with less complexity by reducing the number of different directions in which the block needs to be hit,.
Adaptations will be made when the task is deemed too difficult or easy by the primary researcher and the participant. It will also be adapted by either the primary researcher or the participant.
Adherence will also be measured by a participation checklist, to be measured by the chief investigator (Occupational Therapy student).
There will not be common goals put in place. Rather, the study will just learn if there is any preliminary benefits of using the adapted games and may suggest in the future that common goals be set.
Intervention code [1] 328485 0
Rehabilitation
Comparator / control treatment
no control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338089 0
Change in affected upper limb function
Timepoint [1] 338089 0
Measured once a week, on Friday's post intervention (or regular physiotherapy) on these days, for the entirety of the 6 weeks.
Secondary outcome [1] 434473 0
How usable the system is for the participant?
Timepoint [1] 434473 0
Immediately after the completion of the intervention phase (final day of week 4)
Secondary outcome [2] 434475 0
Did the use of the VR cause virtual reality or motion sickness?
Timepoint [2] 434475 0
Immediately after the completion of the intervention phase (final day of week 4)
Secondary outcome [3] 434477 0
How satisfied were the participants with the use of the VR and associated games?
Timepoint [3] 434477 0
Immediately after the completion of the intervention phase (final day of week 4)

Eligibility
Key inclusion criteria
Currently undergoing rehabilitation, upper limb motor impairment post stroke, upper limb score of less than three on the modified Ashworth scale, one unaffected arm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unstable medical conditions, inability to provide informed consent, speech impairment, cognitive difficulties, corrected vision issues that hinder ability to engage with the Meta Quest 2.

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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/06/2024
Actual
Date of last participant enrolment
Anticipated
12/07/2024
Actual
Date of last data collection
Anticipated
23/08/2024
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 316514 0
University
Name [1] 316514 0
University of South Australia
Country [1] 316514 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Country
Australia
Secondary sponsor category [1] 318571 0
None
Name [1] 318571 0
Address [1] 318571 0
Country [1] 318571 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315025 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 315025 0
https://i.unisa.edu.au/staff/research/research-ethics/human-research-ethics/
Ethics committee country [1] 315025 0
Australia
Date submitted for ethics approval [1] 315025 0
10/11/2023
Approval date [1] 315025 0
21/02/2024
Ethics approval number [1] 315025 0
205901

Summary
Brief summary
This study is intended to identify, adapt, evaluate, preliminary efficacy, and gather patient perspectives of 'off-the-shelf' virtual reality games for use in upper limb rehabilitation after stroke. It aims to find out whether readily available games for virtual reality can be used and modified to best supplement regular physiotherapy rehabilitation post stroke, to also increase therapy hours. The hypothesis is that adapted virtual reality games will be a useful therapeutic tool, and will result in some improvement in upper limb rehabilitation post stroke,.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133462 0
Mr Philip Markov
Address 133462 0
University of South Australia City East Campus. Corner of North Terrace and Frome Road, Adelaide, SA, 5001
Country 133462 0
Australia
Phone 133462 0
+61 424 067 478
Fax 133462 0
Email 133462 0
marpy037@mymail.unisa.edu.au
Contact person for public queries
Name 133463 0
Philip Markov
Address 133463 0
University of South Australia City East Campus. Corner of North Terrace and Frome Road, Adelaide, SA, 5001.
Country 133463 0
Australia
Phone 133463 0
+61 424 067 478
Fax 133463 0
Email 133463 0
marpy037@mymail.unisa.edu.au
Contact person for scientific queries
Name 133464 0
Philip Markov
Address 133464 0
University of South Australia City East Campus. Corner of North Terrace and Frome Road, Adelaide, SA, 5001.
Country 133464 0
Australia
Phone 133464 0
+61 424 067 478
Fax 133464 0
Email 133464 0
marpy037@mymail.unisa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not considered necessary for the scope of this project


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.