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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Innovation in stroke rehabilitation: Determining the feasibility and effectiveness of customised active computer games to improve outcomes following stroke
Scientific title
A pilot investigation of the feasibility and effectiveness of custom-designed active computer games for physical rehabilitation of adult stroke survivors
Secondary ID [1] 281976 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288404 0
Condition category
Condition code
Stroke 288752 288752 0 0
Stroke 288753 288753 0 0

Study type
Description of intervention(s) / exposure
Phase 1: 40 participants will complete one testing session of 40 minutes duration to investigate feasibility and safety of the gaming activities, which utilise a motion-sensing camera and custom-written software. Participants will be randomly assigned to one of four gaming activities. Three of these games primarily involve tracking of hip and shoulder movements to perform actions on the television screen. The remaining game involves tracking of upper limb movements. Participants will work through a protocol of testing which involves using the games in sitting and standing, and through varying levels of difficulty. All sessions will be undertaken on an individual basis under the supervision of a physiotherapist.

Phase 2: Of these 40 participants, 16 will take part in a randomised study. Phase 2 participants will be recruited consecutively from Phase 1 until 16 participants have been recruited. The intervention group will participate in 8 gaming sessions of 40 minutes duration over a 4 week period, in addition to their usual care. During each session participants may interact with all four gaming activities and sessions will be individualised for each participant with guidance from the supervising therapist.
Intervention code [1] 286547 0
Comparator / control treatment
Standard treatment.
The control group will continue with usual care for 4 weeks and will attend assessment sessions only. The amount of usual care will be provided on a case-by-case basis as determined by the rehabilitation team. As participants will be recruited from either the inpatient or outpatient therapy services, usual care may vary from one physiotherapy session per week to daily therapy. The amount of standard physiotherapy and occupational therapy attended will be documented.
Control group

Primary outcome [1] 288893 0
Feasibility. This will include evaluation of recruitment and attrition (screening log and participant flow), gaming activity time, acceptability (5-point Likert scale rating of enjoyment and perceived benefit; and verbal feedback from participants), and safety (11-point VAS rating of pain and fatigue; BORG rating of perceived exertion; and monitoring of adverse events, e.g falls or near misses, and complaints of other symptoms such as dizziness)
Timepoint [1] 288893 0
Recruitment and attrition will be monitored throughout the study. Gaming activity time, acceptability and safety data will be collected during each intervention session.
Secondary outcome [1] 301251 0
Functional Reach Test. A measure of dynamic balance which evaluates forward reach ability.
Timepoint [1] 301251 0
Baseline, 4 weeks
Secondary outcome [2] 301252 0
Step Test. A measure of dynamic balance which involves tapping one foot on and off a step.
Timepoint [2] 301252 0
Baseline, 4 weeks
Secondary outcome [3] 301253 0
6 minute walk test. A measure of walking endurance.
Timepoint [3] 301253 0
Baseline, 4 weeks
Secondary outcome [4] 301254 0
Motor Assessment Scale. A measure of mobility and upper limb function.
Timepoint [4] 301254 0
Baseline, 4 weeks

Key inclusion criteria
Haemorrhagic or ischaemic stroke;
Able to sit unsupported a minimum of 10 seconds
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Medically unstable or other medical condition or neurological impairment that could confound the results;
Severe receptive or expressive dysphasia;
Significant cognitive deficit (MMSE <20)

Study design
Purpose of the study
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 and outpatient therapy service. Screening will be undertaken by the ward physiotherapists and a screening registry kept.
Allocation will be concealed to the research therapists and assessors. The randomisation schedule will be maintained by a therapist not involved in the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Phase 1 (40 participants): Computer generated permuted block randomisation with stratification based on participants Functional Independence Measure (FIM) walking item > 4

Phase 2 (16 participants): Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
Intervention assignment
Other design features
Not Applicable
Type of endpoint/s
Statistical methods / analysis
In Phase 1 (40 participants), we will describe the population, detail the time spent and number of movement repetitions performed in each game, their view of its acceptability and any safety issues. Non-parametric statistics will be used to explore utility according to functional impairment at time of testing (based on participants’ Motor Assessment Scale).

In Phase 2 (16 participants), in addition to the summaries performed in Phase 1, we will describe the participants’ changes in balance and mobility over the 8 sessions. Independent t-tests or Mann-Whitney U tests will be used to compare normally and non-normally distributed data respectively. Repeated measures analysis of variance (ANOVA) will be used to compare changes over time and between group changes in data for the outcome measures. The level of significance will be set at 0.05.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 603 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 6355 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 286753 0
Name [1] 286753 0
National Stroke Foundation of Australia
Country [1] 286753 0
Primary sponsor type
Other Collaborative groups
Florey Neuroscience Institiutes
Melbourne Brain Centre, 245 Burgundy Street, Heidelburg, VIC 3084
Secondary sponsor category [1] 285533 0
Name [1] 285533 0
Melbourne Health
Address [1] 285533 0
The Royal Melbourne Hospital - Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country [1] 285533 0
Other collaborator category [1] 277289 0
Commercial sector/Industry
Name [1] 277289 0
Current Circus
Address [1] 277289 0
Suite 6, 322 St Kilda Road, St Kilda, VIC 3182
Country [1] 277289 0

Ethics approval
Ethics application status
Ethics committee name [1] 288822 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 288822 0
Office for Research, Level 6 East, Main Building, 300 Grattan St, The Royal Melbourne Hospital, Carlton VIC 3050
Ethics committee country [1] 288822 0
Date submitted for ethics approval [1] 288822 0
Approval date [1] 288822 0
Ethics approval number [1] 288822 0

Brief summary
Active gaming technologies are rapidly evolving and increasingly being used in therapeutic environments. The current range of commercially available software is of limited use in the context of stroke rehabilitation. This research study will investigate the safety, feasibility and effectiveness of a suite of customised gaming activities in a stroke population. We hypothesise that the gaming activities will be safe and feasible to use in a stroke population and will improve physical outcomes when used in additional to usual care.
Trial website
Trial related presentations / publications
Bower, K. J., Louie, J., Landesrocha, Y., Seedy, P., Gorelik, A., & Bernhardt, J. (2015). Clinical feasibility of interactive motion-controlled games for stroke rehabilitation. Journal of NeuroEngineering and Rehabilitation, 12(1). doi:10.1186/s12984-015-0057-x
Public notes

Principal investigator
Name 37938 0
Ms Kelly Bower
Address 37938 0
Physiotherapy Department, The Royal Melbourne Hospital Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country 37938 0
Phone 37938 0
+61 3 83872685
Fax 37938 0
+61 3 83872109
Email 37938 0
Contact person for public queries
Name 37939 0
Ms Kelly Bower
Address 37939 0
Physiotherapy Department, The Royal Melbourne Hospital Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country 37939 0
Phone 37939 0
+61 3 83872685
Fax 37939 0
+61 3 83872109
Email 37939 0
Contact person for scientific queries
Name 37940 0
Ms Kelly Bower
Address 37940 0
Physiotherapy Department, The Royal Melbourne Hospital Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country 37940 0
Phone 37940 0
+61 3 83872685
Fax 37940 0
+61 3 83872109
Email 37940 0

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
No additional documents have been identified.