Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000220763
Ethics application status
Approved
Date submitted
18/02/2013
Date registered
25/02/2013
Date last updated
7/03/2018
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
None
Universal Trial Number (UTN)
U1111-1138-6629
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
Ischaemic
Stroke 288753 288753 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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
Rehabilitation
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
Active

Outcomes
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

Eligibility
Key inclusion criteria
Haemorrhagic or ischaemic stroke;
Able to sit unsupported a minimum of 10 seconds
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
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 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
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
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2012
Actual
28/08/2012
Date of last participant enrolment
Anticipated
28/04/2013
Actual
4/04/2013
Date of last data collection
Anticipated
Actual
30/04/2014
Sample size
Target
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
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
Charities/Societies/Foundations
Name [1] 286753 0
National Stroke Foundation of Australia
Country [1] 286753 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Florey Neuroscience Institiutes
Address
Melbourne Brain Centre, 245 Burgundy Street, Heidelburg, VIC 3084
Country
Australia
Secondary sponsor category [1] 285533 0
Hospital
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
Australia
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
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288822 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 288822 0
Ethics committee country [1] 288822 0
Australia
Date submitted for ethics approval [1] 288822 0
09/01/2012
Approval date [1] 288822 0
16/02/2012
Ethics approval number [1] 288822 0
2011.210

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 37938 0
+61 3 83872685
Fax 37938 0
+61 3 83872109
Email 37938 0
kelly.bower@mh.org.au
Contact person for public queries
Name 37939 0
Kelly Bower
Address 37939 0
Physiotherapy Department, The Royal Melbourne Hospital Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country 37939 0
Australia
Phone 37939 0
+61 3 83872685
Fax 37939 0
+61 3 83872109
Email 37939 0
kelly.bower@mh.org.au
Contact person for scientific queries
Name 37940 0
Kelly Bower
Address 37940 0
Physiotherapy Department, The Royal Melbourne Hospital Royal Park Campus, 34-54 Poplar Road, Parkville VIC 3052
Country 37940 0
Australia
Phone 37940 0
+61 3 83872685
Fax 37940 0
+61 3 83872109
Email 37940 0
kelly.bower@mh.org.au

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

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