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Trial registered on ANZCTR


Registration number
ACTRN12612001129875
Ethics application status
Approved
Date submitted
19/10/2012
Date registered
23/10/2012
Date last updated
23/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of Wii System Effectiveness on Stroke in Taiwan
Scientific title
In patients who have suffered a stroke, is virtual reality treatment (Wii) more effective than conventional rehabilitation in improving muscle electromyography performance?
Secondary ID [1] 281414 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 287662 0
Condition category
Condition code
Stroke 288001 288001 0 0
Ischaemic
Stroke 288002 288002 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 288011 288011 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1): the virtual reality group. Participants in the Wii group played publicly available software packages, such as Wii Sport Resort. Games were preselected according to each participant’s motor level, and the movement patterns used in the games were compatible with their conventional occupational therapy. The equipment used in the Wii group consisted of standard gadgets, including the Nintendo Wii console, four Wii controllers, four motion-plus controllers, a home projector and a screen. The virtual reality treatment is supervised by an experienced occupational therapist.
Treatment duration: three weeks (three sessions per week, one hour per session)
Intervention code [1] 285905 0
Treatment: Other
Intervention code [2] 285917 0
Rehabilitation
Comparator / control treatment
Group 2) the conventional group: standard occupational therapy ;
Group 3) the placebo board game group: mahjong, cards, and checkers;
Group 4) the no treatment control group.
Treatment duration: three weeks (three sessions per week, one hour per session)
Control group
Active

Outcomes
Primary outcome [1] 288213 0
The electromyography performance of time-to-peak (TTP) contractions in biceps, triceps, deltoid, flexor carpi radialis and externsor carpi radialis muscles
Timepoint [1] 288213 0
The baseline, outcome and follow-up measurements were performed prior to treatment (week 0), immediately after treatment (week 4), and four weeks after treatment (week 8).
Secondary outcome [1] 299613 0
motivation by using the Intrinsic Motivation Inventory
Timepoint [1] 299613 0
The baseline, outcome and follow-up measurements were performed prior to treatment (week 0), immediately after treatment (week 4), and four weeks after treatment (week 8).

Eligibility
Key inclusion criteria
1) age 20 to 80 years; 2) evidence of a unilateral and first cerebral vascular accident confirmed either by a CT or an MRI head scan (ischemic or hemorrhagic); 3) onset of symptoms for at least six months; 4) ability to follow simple instructions with a Mini-Mental State Examination score greater than 24; 5) ability to produce active shoulder movements on the side of hemiparesis (Fugl-Meyer Assessment Scale greater than or equal to 21); 6) no obvious pain in the affected limb (visual analog scale less than 4); 7) minimal spasticity in the affected limb (Modified Ashworth Scale less than or equal to 2); 8) signed written informed consent before participation.
Minimum age
20 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) uncontrolled hypertension (greater than 190/110 mm Hg); 2) unstable angina; 3) any history of seizure, except for febrile seizures during childhood; 4) carrying or having an implanted artificial pacemaker; 5) participation in other clinical trials; 6) inability to cooperate with research team due to cognitive or personal factors

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4613 0
Taiwan, Province Of China
State/province [1] 4613 0

Funding & Sponsors
Funding source category [1] 286177 0
Hospital
Name [1] 286177 0
E-Da Hospital
Address [1] 286177 0
1 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan.
Country [1] 286177 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
E-Da Hospital
Address
1 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 284989 0
University
Name [1] 284989 0
I-Shou University
Address [1] 284989 0
8 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan.
Country [1] 284989 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288247 0
E-DA Hospital Institutional Review Board
Ethics committee address [1] 288247 0
E Da Hospital, 1 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan.
Ethics committee country [1] 288247 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 288247 0
17/08/2010
Approval date [1] 288247 0
08/10/2010
Ethics approval number [1] 288247 0
EMRP-099-046

Summary
Brief summary
This study was a randomized, single blind and placebo-controlled trial with four parallel groups receiving three-week treatments. Participants were assigned to one of four groups: 1) VR via Wii gaming; 2) conventional occupational therapy; 3) a placebo board game; 4) no treatment. The training effects were evaluated immediately after and four weeks after treatment. Electromyography activity and motivation inventory were the main and secondary outcome measurements. The hypothesis of the current study is that off-the-shelf virtual reality treatment imrpoves muscle activation perofrmance and treatment motivation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34851 0
Address 34851 0
Country 34851 0
Phone 34851 0
Fax 34851 0
Email 34851 0
Contact person for public queries
Name 18098 0
Shih-Chen Fan
Address 18098 0
College of Medicine, I-Shou University, 8 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan
Country 18098 0
Taiwan, Province Of China
Phone 18098 0
886-76151100#7514
Fax 18098 0
Email 18098 0
maggiefan15@gmail.com
Contact person for scientific queries
Name 9026 0
Shih-Chen Fan
Address 9026 0
College of Medicine, I-Shou University, 8 E-Da Road, Yan-Chao Dist, Kaohsiung 824, Taiwan
Country 9026 0
Taiwan, Province Of China
Phone 9026 0
886-76151100#7514
Fax 9026 0
Email 9026 0
maggiefan15@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary