Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000134820
Ethics application status
Approved
Date submitted
19/11/2020
Date registered
10/02/2021
Date last updated
10/02/2021
Date data sharing statement initially provided
10/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a virtual reality-based rehabilitation program for older adults undergoing inpatient rehabilitation.
Scientific title
Evaluation of a virtual reality-based rehabilitation program to improve strength and mobility outcomes for older adults undergoing inpatient rehabilitation for non-stroke related conditions.
Secondary ID [1] 302805 0
Nil known
Universal Trial Number (UTN)
Trial acronym
VIGOR (VIrtual reality Gamification for Older Rehabilitation patients)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deconditioned post medical illness 319774 0
Condition category
Condition code
Physical Medicine / Rehabilitation 317708 317708 0 0
Other physical medicine / rehabilitation
Musculoskeletal 318137 318137 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study design:
-The study will be performed at Brunswick Private Hospital, which is a dedicated rehabilitation facility. The study will run for 4 months. The plan to enrol 30 patients who require rehabilitation for orthopaedic, musculoskeletal or general reconditioning post medical or surgical illness. Their outcomes will be compared to 30 aged matched historical controls whose data will be collected as a standard part of musculoskeletal rehabilitation. Exercises were developed by Prof Kwang Lim in consultation with treating physiotherapists and occupations therapists based on standard therapy. ALO were involved in software design of appropriate virtual reality programs that include ( four seated exercises; arm extensions, hip flexion, knee extension and lateral trunk movements.

Equipment required:
Virtual reality goggles – these will be uploaded with the ALO VR software
Virtual reality sensors – for upper/lower limbs
ALO Virtual reality software

Therapy Session:
Therapy session will be 20 minutes daily for 14 days.
Therapy will be one-on-one.
Therapy attendance will be recorded.
Setup of session – 15 minutes
Initial setup of room
Setup of 4 seated stations with allocated VR goggles
Transfer of patients from ward area to therapy room
Application of VR sensors – application of Velcro sensors to both wrists and legs which work in conjunction with the VR goggles and software. This will allow the VR goggles to track the patient’s movement
Initial calibration of VR goggles – this will take approximately 2 minutes to occur per patient. The patient will have the goggles placed on their face (similarly positioned to that of glasses or sunglasses).
Patients will remain seated in the same position and VR goggles will be able to switch between different programs.

Provision of VR therapy session:
-The VR session will last for approximately 5 minutes and the patient is expected to undertake a total of 4 stations per therapy session
-There are two stations that focus on lower limb movement, one station for trunk movement and one station for upper limb movement
-Once initial setup and calibration has occurred, session can commence

Therapy stations:
1. Lower limb station (1) – the patient will be in a seated position and the patient will wear the VR goggles and will be required to stamp on virtual boxes. This exercise is anticipated to improve function with hip flexion/extension.
2. Lower limb station (2) – the patient will be in a seated position and the patient will wear the VR goggles and will be required to kick virtual footballs. This exercise is anticipated to improve function with knee flexion/extension.
3. Trunk station - the patient will be in a seated position and the patient will wear the VR goggles and will be required to catch virtual musical notes with a trumpet. This exercise is anticipated to improve function with lateral trunk flexion, core stability, seated balance.
4. Upper limb station - the patient will be in a seated position and the patient will wear the VR goggles and will be required box objects in front of them. This exercise is anticipated to improve function with shoulder/elbow flexion/extension
Intervention code [1] 319091 0
Rehabilitation
Intervention code [2] 319400 0
Treatment: Devices
Comparator / control treatment
30 aged matched historical controls whose data will be collected as a standard part of musculoskeletal rehabilitation form the preceding 3 months at Brunswick Private Hospital.
Control group
Historical

Outcomes
Primary outcome [1] 325747 0
Feasibility and patient acceptability of intervention is assessed by study and device-specific patient feasibility questionnaire.
Timepoint [1] 325747 0
14 days post-commencement of intervention.
Secondary outcome [1] 389076 0
Functional mobility as assessed with the timed up and go test
Timepoint [1] 389076 0
14 days post-commencement of interveniton.
Secondary outcome [2] 389077 0
Knee extension strength.
This is tested using a dynamometer.
The Kg/force reading is then documented as the outcome of the assessment
Timepoint [2] 389077 0
14 days post-commencement of intervention.
Secondary outcome [3] 389078 0
Functional ambulation classification.
A functional test which evaluates the patient’s mobility ability determining the requirements of a mobility aid and/or carer support
Timepoint [3] 389078 0
14 days post-commencement of intervention.
Secondary outcome [4] 389079 0
Hopkins rehabilitation engagement scale.
A therapist reported outcome regarding the engagement throughout the virtual reality exercise trial.
Timepoint [4] 389079 0
14 days post-commencement of intervention.

Eligibility
Key inclusion criteria
Patients requiring rehabilitation for musculoskeletal/orthopaedic rehabilitation of reconditioning post medical or surgical illness
Ability to provide consent
Aged 65 years and above
Able and willing to consent to VR exercises
Able to follow two stage commands
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke rehabilitation patients
Unable to consent (e.g.: non-English speaking)
Below 65 years of age
Patients with dementia
Non weight bearing on lower limbs
Claustrophobia or Vestibular or Symptoms of dizziness
No specific medications should preclude patient participation

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
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
15/02/2021
Actual
Date of last participant enrolment
Anticipated
14/05/2021
Actual
Date of last data collection
Anticipated
14/05/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18060 0
Brunswick Private Hospital - Brunswick
Recruitment postcode(s) [1] 32038 0
3056 - Brunswick

Funding & Sponsors
Funding source category [1] 307231 0
Hospital
Name [1] 307231 0
Brunswick Private Hospital
Country [1] 307231 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ALO
Address
IMDA PIXEL
10 Central Exchange Green
Singapore 138649
Country
Singapore
Secondary sponsor category [1] 307872 0
None
Name [1] 307872 0
Address [1] 307872 0
Country [1] 307872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307327 0
Bellberry Limited
Ethics committee address [1] 307327 0
Ethics committee country [1] 307327 0
Australia
Date submitted for ethics approval [1] 307327 0
15/01/2020
Approval date [1] 307327 0
25/11/2020
Ethics approval number [1] 307327 0

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

Contacts
Principal investigator
Name 106846 0
Prof Kwang Lim
Address 106846 0
The Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3052
Country 106846 0
Australia
Phone 106846 0
+61 3 9342 2635
Fax 106846 0
Email 106846 0
[email protected]
Contact person for public queries
Name 106847 0
Joseph Ciantar
Address 106847 0
The Royal Melbourne Hospital
300 Grattan STreet
Parkville VIC 3052
Country 106847 0
Australia
Phone 106847 0
+61 3 9342 7000
Fax 106847 0
Email 106847 0
[email protected]
Contact person for scientific queries
Name 106848 0
Joseph Ciantar
Address 106848 0
The Royal Melbourne Hospital
300 Grattan STreet
Parkville VIC 3052
Country 106848 0
Australia
Phone 106848 0
+61 3 9342 7000
Fax 106848 0
Email 106848 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
Confidentiality. Sample size unlikely to yield statistically significant results, this is a pilot study to assess feasibility. Future studies coming from this work would be more meaningful.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9803Study protocol  [email protected] Available through direct contact with researchers.
9804Informed consent form  [email protected] Available through direct contact with researchers.



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.