Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000725268
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of virtual reality games as an adjunct in improving upper limb function and general health among stroke survivors.
Scientific title
Effectiveness of virtual reality games as an adjunct to usual physiotherapy care in improving upper limb strength, dexterity, sensory function, activities of daily living and quality of life among stroke survivors.
Secondary ID [1] 294281 0
Nil known
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke 306970 0
Condition category
Condition code
Stroke 306066 306066 0 0
Haemorrhagic
Stroke 306742 306742 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involved 36 stroke survivors in both experimental and control groups. The experimental group (n=18) had 0.5 hours of upper limb (UL) virtual reality games (VRG) using Cy-Wee game controller and another 1.5 hours of standard physiotherapy exercises. The UL VRG was administered individually (one-on-one) to the participants with assistance from a physiotherapist for 0.5 hours. The VRG for experimental group comprised of playing games on a computer using a Cy-Wee Z game controller which was incorporated into a custom-made handlebar. Cy-Wee Z is a movement-based game controller which is quite similar to the Nintendo-Wii controller. Appropriate games selection provides various series of physical challenges such as stationary target-hitting games, moving target-hitting games and also sports games. All of the games required large cursor movements in both the horizontal and vertical direction to stimulate the movement of affected UL. The intervention for experimental group was performed once a week for a continuous 8 weeks. Attendance checklist was taken to monitor participants’ adherence in this study. Outcome measures were Fugl-Meyer Assessment for Upper Extremities (FMA-UE), Wolf Motor Function Test (WMFT), Intrinsic Motivation Inventory (IMI), The Lawton of Instrumental Activities of Daily Living (IADL) and Stroke Impact Scale (SIS) assessed at baseline and 8 weeks post-intervention. Measurement of outcomes was carried out by an independent assessor at week 0 and week 8 of intervention with the use of standardised tools.
Intervention code [1] 300577 0
Rehabilitation
Comparator / control treatment
The control group (n=18) continued with their 2 hours of usual physiotherapy care (individually-tailored exercise) supervised by a physiotherapist. Each usual physiotherapy care comprised of stretching, strengthening, gait training, coordination, balance and functional exercises such as sit to stand and stairs climbing. There were no specific guidelines used for exercise programme in control group. Control groups received 8 therapy sessions; 1 session per week for 8 continuous weeks. Attendance checklist was taken to monitor participants’ adherence in this study. Outcome measures were Fugl-Meyer Assessment for Upper Extremities (FMA-UE), Wolf Motor Function Test (WMFT), Intrinsic Motivation Inventory (IMI), The Lawton of Instrumental Activities of Daily Living (IADL) and Stroke Impact Scale (SIS) assessed at baseline and 8 weeks post-intervention.Measurement of outcomes was carried out by an independent assessor at week 0 and week 8 of intervention with the use of standardised tools.
Control group
Active

Outcomes
Primary outcome [1] 305102 0
Fugl-Meyer Assessment for Upper Extremities (FMA-UE).
FMA-UE is a measure of UL motor and sensory impairment.
Timepoint [1] 305102 0
Measurement was carried out by an independent assessor at week 0 (before intervention) and week 8 (after intervention) with the use of standardized tools.
Primary outcome [2] 305672 0
Wolf Motor Function Test (WMFT).
WMFT is a quantitative measure of UL motor ability through timed and functional tasks.
Timepoint [2] 305672 0
Measurement was carried out by an independent assessor at week 0 (before intervention) and week 8 (after intervention) with the use of standardized tools.
Secondary outcome [1] 344166 0
Stroke Impact Scale (SIS).
SIS is a stroke-specific and self-report questionnaire to evaluate disability and quality of life after stroke
Timepoint [1] 344166 0
Measurement was carried out by an independent assessor at week 0 (before intervention) and week 8 (after intervention) with the use of standardized tools.
Secondary outcome [2] 346118 0
The Lawton of Instrumental Activities of Daily Living (IADL).
The Lawton IADL scale assesses the more complex ADLs necessary for living in the community.
Timepoint [2] 346118 0
Measurement was carried out by an independent assessor at week 0 (before intervention) and week 8 (after intervention) with the use of standardized tools.
Secondary outcome [3] 346119 0
Intrinsic Motivation Inventory (IMI).
IMI is a qualitative multidimensional questionnaire to assess subject’s subjective experience related to an activity.
Timepoint [3] 346119 0
Measurement was carried out by an independent assessor at week 0 (before intervention) and week 8 (after intervention) with the use of standardized tools.

Eligibility
Key inclusion criteria
The inclusion criteria were the following:
(1) stroke survivors (at least six months post-stroke),
(2) age 18 years and above,
(3) voluntary movement in their arm affected by stroke (Motor Assessment Scale of upper arm function score of at least 4 out of 6) and
(4) able to participate in the VRG training without limitation (presently with good health and no self-reported orthopaedic, medical or painful conditions).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors diagnosed with severe cognitive impairments were excluded from the study.

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
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 was analyzed using Statistic Product for Statistical Solutions (SPSS) version 19.0 (SPSS Inc. Chicago, USA). Repeated measure ANOVA was used to analyze the effects of time, group and time group interaction. Significant level was set at p < 0.05.
ANCOVA and Chi-Square test demonstrated that there was no significant effect of age, post-stroke duration and affected side of stroke as dependent variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
15/06/2013
Date of last data collection
Anticipated
Actual
15/09/2013
Sample size
Target
40
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 9667 0
Malaysia
State/province [1] 9667 0
Selangor

Funding & Sponsors
Funding source category [1] 298923 0
University
Name [1] 298923 0
Universiti Kebangsaan Malaysia
Country [1] 298923 0
Malaysia
Primary sponsor type
University
Name
Universiti Kebangsaan Malaysia
Address
Universiti Kebangsaan Malaysia,
43600, Bangi,
Selangor, Malaysia.
Country
Malaysia
Secondary sponsor category [1] 298601 0
None
Name [1] 298601 0
Address [1] 298601 0
Country [1] 298601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299861 0
Secretariat for Research and Ethics of Universiti Kebangsaan Malaysia.
Ethics committee address [1] 299861 0
Ethics committee country [1] 299861 0
Malaysia
Date submitted for ethics approval [1] 299861 0
15/11/2012
Approval date [1] 299861 0
22/02/2013
Ethics approval number [1] 299861 0
UKM1.5.3.5/244/NN-110-2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2491 2491 0 0
/AnzctrAttachments/374684-Ethical Approval.pdf (Ethics approval)
Attachments [2] 2492 2492 0 0
/AnzctrAttachments/374684-MJM-Volume-72Supp2-2017.pdf (Supplementary information)

Contacts
Principal investigator
Name 81794 0
A/Prof Devinder Kaur Ajit Singh
Address 81794 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 81794 0
Malaysia
Phone 81794 0
+60326878037
Fax 81794 0
+60326878199
Email 81794 0
[email protected]
Contact person for public queries
Name 81795 0
Devinder Kaur Ajit Singh
Address 81795 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 81795 0
Malaysia
Phone 81795 0
+60326878037
Fax 81795 0
+60326878199
Email 81795 0
[email protected]
Contact person for scientific queries
Name 81796 0
Devinder Kaur Ajit Singh
Address 81796 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs, Faculty of Health Sciences, Jalan Raja Muda Abdul Aziz, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur, Malaysia.
Country 81796 0
Malaysia
Phone 81796 0
+60326878037
Fax 81796 0
+60326878199
Email 81796 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseVirtual reality games as an adjunct in improving upper limb function and general health among stroke survivors.2019https://dx.doi.org/10.3390/ijerph16245144
N.B. These documents automatically identified may not have been verified by the study sponsor.