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Trial registered on ANZCTR


Registration number
ACTRN12612000722897
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
5/07/2012
Date last updated
8/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Wiihabilitation": Can active gaming systems be used to improve recovery after stroke?
Scientific title
Pilot investigation of the efficacy and feasibility of the Nintendo Wii(TM) gaming system to improve balance performance post-stroke in an inpatient rehabilitation setting
Secondary ID [1] 280652 0
Nil
Universal Trial Number (UTN)
U1111-1131-6567
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 286673 0
Condition category
Condition code
Stroke 286970 286970 0 0
Ischaemic
Stroke 287056 287056 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Both the intervention (Balance Group) and active control (Upper Limb Group) will undertake sessions using the Nintendo Wii(TM) gaming system in addition to their standard inpatient therapy regime. Sessions for both groups will be 45 minutes in length, three times per week, for a minimum of two and a maximum of four weeks. The length of intervention will be determined by the length of stay and discharge date of the participant, established by the rehabilitation team.

The Balance Group will perform a range of activities using the 'Wii Fit Plus' package, which involves standing on a force plate (the Wii Balance Board(TM)). The investigators have developed guidelines for activity selection which provides a hierarchy of difficulty and offers a range of activities to challenge balance. Activities will include stationary stance with a decreasing base of support (e.g. Yoga Deep Breathing and Standing Knee Pose), movement over a fixed base of support (e.g. Table Tilt and Penguin Slide), and movement with a changing base of support (e.g. Free Jogging and Free Step). The activity selection will also be based on participant preferences and functional ability. Sessions will be conducted on an individual basis and supervised by a trained physiotherapist.

All participants will continue their standard inpatient therapy during the course of the study. This involves participation in allied health sessions (e.g. physiotherapy, occupational therapy and speech pathology) on an individual basis or in a group setting. The amount of standard therapy is typically between two to four sessions per day, each up to one hour in length, five days per week. Standard therapy is established on a case by case basis by the rehabilitation team and will be independent of the researchers. A therapy log will be used to document the amount and type of standard treatment received.
Intervention code [1] 285055 0
Rehabilitation
Intervention code [2] 285212 0
Treatment: Other
Comparator / control treatment
The active control (Upper Limb Group) will participate in an equivalent number of sessions as the Balance Group, however this group will be using the 'Wii Sports' and/or 'Sports Resort' packages. The Upper Limb Group participants will perform activities in a seated position, using one or two motion-sensitive controllers, and be encouraged to use their affected upper limb where possible. The sports-themed activities will involve the use of whole or part of the upper limb and include activities such as boxing, table tennis and bowling. Activity selection will take into consideration individual participant preferences and functional capacity of the upper limb. Sessions will be conducted on an individual basis and supervised by a trained physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 287307 0
Step Test. A measure of balance which evaluates speed of performing a dynamic task (tapping one foot on and off a step).
Outcome data: number of successful steps performed in 15 seconds or until the participant requires steadying due to loss of balance.
Timepoint [1] 287307 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Primary outcome [2] 287308 0
Functional Reach Test. A measure of balance which evaluates forward reach ability in bilateral stance.
Outcome data: distance reached (cm)
Timepoint [2] 287308 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Secondary outcome [1] 297874 0
Timed Up and Go Test. A measure of balance and mobility which assesses the speed of performing several manoevres that potentially threaten balance.
Outcome data: time taken to perform (seconds)
Timepoint [1] 297874 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Secondary outcome [2] 297875 0
Stroke Rehabilitation Assessment of Movement (STREAM). A measure of motor function which evaluates evaluates upper limb movement, lower limb movement and basic mobility by scoring 30 items on a 3 or 4 point ordinal scale.
Outcome data: total score and sub-scores (out of 100)
Timepoint [2] 297875 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Secondary outcome [3] 297876 0
Motor Assessment Scale - Upper Limb (MAS-UL). A measure of upper limb motor function.
Outcome data: score out of 6 for each of the 3 categories
Timepoint [3] 297876 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Secondary outcome [4] 297877 0
Centre of pressure (COP) data obtained from a force platform (Wii Balance Board(TM)). Involves measurement of static (feet apart with eyes open and eyes closed) and dynamic (mediolateral weight shifting) balance.
Outcome data: COP path lengths
Timepoint [4] 297877 0
Baseline, 2 weeks and 3-4 weeks after intervention commencement
Secondary outcome [5] 297878 0
Feasibility. This will include evaluation of recruitment and attrition (screening log and participant flow), activity time, participant acceptability (5-point Likert scale rating of enjoyment, ease-of-use and perceived benefit), and safety (11-point VAS rating of pain and fatigue, BORG rating of perceived exertion and monitoring of adverse events).
Timepoint [5] 297878 0
Recruitment and attrition will be monitored continuously throughout the study. Activity time, acceptability and safety will be monitored during each intervention session.

Eligibility
Key inclusion criteria
Haemorrhagic or ischaemic stroke less than 3 months ago; Currently receiving inpatient rehabilitation; Able to stand unsupported for a minimum of 30 seconds; Able to use at least one upper limb functionally
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medically unstable; Cardiac pacemaker; Other medical condition or neurological impairment that could confound the results; Cerebellar stroke; Moderate to severe receptive, or severe expressive dysphasia; Significant cognitive deficit; Anticipated inpatient rehabilitation length of stay of less than 3 weeks

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)
Participants will be consecutively sampled by screening all stroke admissions to the inpatient rehabilitation ward. Screening will be undertaken by the ward physiotherapists and a screening registry kept. The Principal Investigator will confirm eligibility of potential participants and obtain informed consent.

Following enrolment and initial assessment, a minimisation procedure will be used to generate group allocation. Minimisation will be based on the participant's Stroke Rehabilitation Assessment of Movement (STREAM) score, a test of motor function.

The Principal Investigator will be unaware of group allocation until the STREAM score is entered into the Excel-based program and allocation obtained. The allocation is therefore concealed prior to the participant completing their baseline assessment.

An audit of the screening registry and minimisation program will be performed at the end of the study to verify adherence to the allocation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation, based on the STREAM score, will be used to generate the allocation sequence. The Excel-based program attempts to minimise the variance within groups with respect to the STREAM score.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/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 in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 285421 0
Government body
Name [1] 285421 0
NHMRC Postgraduate Scholarship
Address [1] 285421 0
National Health and Medical Research Council,
Level 1, 16 Marcus Clark St, Canberra, ACT 2601
Country [1] 285421 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, 200 Berkeley St, Carlton, VIC 3010
Country
Australia
Secondary sponsor category [1] 284270 0
Hospital
Name [1] 284270 0
Melbourne Health
Address [1] 284270 0
The Royal Melbourne Hospital, Royal Park Campus, 34-54 Poplar Rd, Parkville, VIC 3052
Country [1] 284270 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287431 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 287431 0
Office for Research, Level 6 East, Main Building, 300 Grattan St, The Royal Melbourne Hospital, Parkville, VIC 3050
Ethics committee country [1] 287431 0
Australia
Date submitted for ethics approval [1] 287431 0
Approval date [1] 287431 0
12/07/2010
Ethics approval number [1] 287431 0
2010.117
Ethics committee name [2] 287432 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [2] 287432 0
Melbourne Research, The University of Melbourne, Level 5 Alan Gilbert Building, 161 Barry St, Carlton, VIC 3053
Ethics committee country [2] 287432 0
Australia
Date submitted for ethics approval [2] 287432 0
Approval date [2] 287432 0
24/03/2011
Ethics approval number [2] 287432 0
1135242

Summary
Brief summary
Deficits in balance are common and debilitating following stroke. Active gaming systems, such as the Nintendo Wii(TM), may provide a means of promoting physical activity to improve recovery post-stroke. We hypothesise that the Nintendo Wii(TM) gaming system, when used in addition to standard inpatient rehabilitation therapy will result in improved balance outcomes in a sub-acute stroke population. We also hypothesise that this system will be a feasible tool for use in an inpatient rehabilitation setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34296 0
Dr Kelly Bower
Address 34296 0
Royal Melbourne Hospital
Grattan St, Parkville VIC 3050
Country 34296 0
Australia
Phone 34296 0
+61 3 83872685
Fax 34296 0
Email 34296 0
kelly.bower@mh.org.au
Contact person for public queries
Name 17543 0
Dr Kelly Bower
Address 17543 0
Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, 200 Berkeley St, Carlton, VIC 3010
Country 17543 0
Australia
Phone 17543 0
+61 3 8344 4171
Fax 17543 0
+61 3 8344 4188
Email 17543 0
kelly.bower@mh.org.au
Contact person for scientific queries
Name 8471 0
Dr Kelly Bower
Address 8471 0
Department of Physiotherapy, Melbourne School of Health Sciences, The University of Melbourne, 200 Berkeley St, Carlton, VIC 3010
Country 8471 0
Australia
Phone 8471 0
+61 3 8344 4171
Fax 8471 0
+61 3 8344 4188
Email 8471 0
kelly.bower@mh.org.au

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