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Trial registered on ANZCTR


Registration number
ACTRN12622000363785
Ethics application status
Approved
Date submitted
13/12/2021
Date registered
1/03/2022
Date last updated
1/03/2022
Date data sharing statement initially provided
1/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Virtual Exercise Gaming on Upper Limb Function in Stroke Survivors
Scientific title
Effects of Remotely Monitored Virtual Exercise Gaming on Upper Limb Function in Stroke Survivors
Secondary ID [1] 306038 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 324674 0
Poor motor function of upper limb 324675 0
Poor Quality of Life 324676 0
Condition category
Condition code
Stroke 322122 322122 0 0
Ischaemic
Physical Medicine / Rehabilitation 322124 322124 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will be equipped with Online Rehab Virtual Assistant (ORVA) for their home exercise in addition to standard treatment received in Hospital. Intervention will be performed around 30-40 minutes per session, 5 times a week for continuous 12 weeks.
ORVA is a remotely monitored system virtual reality. An application will be install in participant's or career's smartphone or tablet. Then, participants will be equipped with wrist/arm mounting strip, a micro USB cable, an Infrared (IR) sensor, and a Bluetooth Low Energy (BLE) dongle. Next, the participants and their career will attend a 1-hour briefing by the research team at the hospital before commencing the home exercises.
The ORVA games that will be used for Intervention group comprised of 3 virtual games for upper limb exercise: 1) Cube and Hole, 2)Catching and 3) Fishing. All of the games required large cursor movements in both the horizontal and vertical direction to stimulate movement of upper extremities. There are different levels of difficulty which can be set by the therapist based on participants' progress. All the progression will be assessed through the system which is connected to the application and also by the physiotherapist in the hospital.
Intervention code [1] 322437 0
Rehabilitation
Comparator / control treatment
Control will undergo standard physiotherapy treatment protocol in hospital setting and standard home-based exercise such as flexibility exercises, stretching, strengthening and coordination.
Control group
Active

Outcomes
Primary outcome [1] 329888 0
Fugl-Meyer Assessment Upper Limb section: upper limb motor function (strength, movement, coordination, and reflex action)
Timepoint [1] 329888 0
Baseline, week 7, week 13 (primary time point) post-commencement of intervention
Secondary outcome [1] 404175 0
Stroke Impact Scale (SIS): quality of life
Timepoint [1] 404175 0
Baseline, week 7, week 13 post-commencement of intervention
Secondary outcome [2] 404176 0
Standardized Mini mental state examination (SMMSE): cognitive ability
Timepoint [2] 404176 0
Baseline, week 7, week 13 post-commencement of intervention
Secondary outcome [3] 404177 0
Lawton Instrumental Activities of Daily Living Scale (Lawton IADL): to assess the more complex ADLs necessary for living in the community.
Timepoint [3] 404177 0
Baseline, week 7, week 13 post-commencement of intervention
Secondary outcome [4] 406490 0
Wolf Motor Function Test (WMFT) : upper extremity motor ability (dexterity, strength and upper extremity function)
Timepoint [4] 406490 0
Baseline, week 7, week 13 post-commencement of intervention

Eligibility
Key inclusion criteria
i) Acute stroke survivors with impairments of upper limb (definite diagnosis of stroke that occurred less than or equal to 1 month)
ii) Adults with stroke (participants had to be greater than or equal to 18 years old)
iii) Adults with stroke who can participate in the virtual reality games intervention program without limitation (presently with good health and no self-reported orthopaedic, medical or painful conditions).
iv) Adults with stroke who are able to provide written informed consent.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Adults with stroke who have severe cognitive impairments and inability to understand the project and its requirements e.g. dementia and receptive aphasia (Mini Mental State Examination score less than 17).
ii) Adults with stroke who are taking any prescribed drugs that could potentially affect physical function and balance such as corticosteroids, antipsychotic or antidepressants.

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)
Treatment allocation will be concealed in sealed, opaque envelopes and stored in a secure location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random number sequence will be created by an independent investigator with random block sizes of four, six and eight, in order to ensure similar size among the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data obtained from this study will be analyzed by using software, Statistic Product for Statistical Solutions (SPSS) version 25.0 (SPSS Inc. Chicago, USA).
The data also will be tested for normality of distribution to identify whether the data is normally distributed or abnormally distributed. If the data is normally distributed, Student’s t test will be performed while if the data is abnormally distributed the test will be used is Mann Whitney U test. These test functions to test the mean scores of pre-intervention and post-intervention measurements for each group (intervention and control groups).
Generalized linear Model repeated measures will be used to compare the mean score between Intervention and Control groups for pre- and post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/03/2022
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 24398 0
Malaysia
State/province [1] 24398 0
Federal Territory of Kuala Lumpur

Funding & Sponsors
Funding source category [1] 309269 0
Commercial sector/Industry
Name [1] 309269 0
PicoSys SDN BHD
Country [1] 309269 0
Malaysia
Primary sponsor type
Commercial sector/Industry
Name
PicoSys SDN BHD
Address
SS-02-26 Skypod Square, Persiaran Puchong Jaya Selatan, Bandar Puchong Jaya, 47100 Puchong, Selangor
Country
Malaysia
Secondary sponsor category [1] 311512 0
None
Name [1] 311512 0
Address [1] 311512 0
Country [1] 311512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309108 0
Sekretariat Etika Penyelidikan UKM
Ethics committee address [1] 309108 0
Tingkat 1, Blok Klinikal, Pusat Perubatan UKM
Jalan Yaakob Latiff, Bandar Tun Razak
56000 Cheras,
Kuala Lumpur.
Ethics committee country [1] 309108 0
Malaysia
Date submitted for ethics approval [1] 309108 0
21/04/2021
Approval date [1] 309108 0
28/06/2021
Ethics approval number [1] 309108 0
JEP-2021-300

Summary
Brief summary
The 36 Acute stroke survivors with impairments of upper limb (definite diagnosis of stroke that occurred within 1 month) will be randomized to either the intervention or the control group using block randomization. A computer-generated random number sequence will be created by an independent investigator with random block sizes of four, six and eight, in order to ensure similar size among the groups. Treatment allocation will be concealed in sealed, opaque envelopes and stored in a secure location. To prevent bias, assessors will be blind to group allocation. And data analysis will be undertaken by a statistician who is blind to group allocation. Intervention group will be equipped with Online Rehab Virtual Assistant (ORVA) for their home exercise in addition to standard treatment received in Hospital. Intervention will be performed twice a week for continuous 12 weeks. Control will undergo standard physiotherapy treatment protocol in hospital setting and standard home-based exercise. Primary outcome of this study will be upper limb motor function (strength, movement, coordination, and reflex action). Baseline measurements of the entire participant in both groups will be measured again after 6 weeks of intervention, on 7th week, and after 12 weeks, on 13th week. We hypothesise that the remotely monitored virtual reality gaming will be effective to improve upper limb function in stroke survivors
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113002 0
Prof Devinder Kaur Ajit Singh
Address 113002 0
CENTER FOR HEALTHY AGEING AND WELLNESS (H-Care), Faculty of Health Sciences, Universiti Kebangsaan Malaysia Campus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 113002 0
Malaysia
Phone 113002 0
+60392897163
Fax 113002 0
Email 113002 0
[email protected]
Contact person for public queries
Name 113003 0
Devinder Kaur Ajit Singh
Address 113003 0
CENTER FOR HEALTHY AGEING AND WELLNESS (H-Care), Faculty of Health Sciences, Universiti Kebangsaan Malaysia Campus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 113003 0
Malaysia
Phone 113003 0
+60392897163
Fax 113003 0
Email 113003 0
[email protected]
Contact person for scientific queries
Name 113004 0
Devinder Kaur Ajit Singh
Address 113004 0
CENTER FOR HEALTHY AGEING AND WELLNESS (H-Care), Faculty of Health Sciences, Universiti Kebangsaan Malaysia Campus Kuala Lumpur, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Federal Territory of Kuala Lumpur
Country 113004 0
Malaysia
Phone 113004 0
+60392897163
Fax 113004 0
Email 113004 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


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.