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Trial registered on ANZCTR


Registration number
ACTRN12613001079730
Ethics application status
Approved
Date submitted
25/09/2013
Date registered
26/09/2013
Date last updated
26/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Table Top Exerciser and Virtual Reality for upper limb rehabilitation of people with stroke.
Scientific title
Effect of use of a Table Top Exerciser and Virtual Reality in a chronic stroke population on the upper limb component of the Fugl-Meyer score.
Secondary ID [1] 283301 0
Nil
Universal Trial Number (UTN)
U1111-1148-4640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 290186 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290574 290574 0 0
Other physical medicine / rehabilitation
Stroke 290582 290582 0 0
Ischaemic
Stroke 290583 290583 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are studying the effectiveness of a non-robotic assistive device (the Smart Skate) used in conjunction with computer games (virtual reality) in improving arm function in stroke survivors. The Smart Skate is a unilateral exercise device which is operated on a table top, similar conceptually to traditional sliding board exercises to allow reaching while supported against gravity. The Smart Skate comprises a tray that supports the lower arm, with Velcro straps to hold the arm on the tray. Embedded within the support, beneath the hand, is a standard computer mouse that controls a cursor on a computer screen. Participants play a range of specially developed computer games which encourage reaching movements. The intervention last for 4 - 6 weeks, with participants playing 45 - 60 min of computer games 4 days per week until a 16 hours of intervention is completed, based on the findings of Kwakkel et al (2004). Participants are supervised and the amount of time spent playing computer games is recorded to determine adherence.
Intervention code [1] 288024 0
Rehabilitation
Comparator / control treatment
No control treatment is given per se. An ABA design was used such that participants act as their own control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290592 0
Upper limb component of the Fugl-Meyer assessment
Timepoint [1] 290592 0
Administered at the start of the study (T0), 4 weeks later after no intervention (T1), after a 4 - 6 week intervention (T2), 4 weeks after intervention is complete (T3)
Secondary outcome [1] 304861 0
Muscle strength: isometric strength of the shoulder and elbow were measured with an IRL hand held dynamometer (Janssen and Le-Ngoc 2009). The following measures were taken: Shoulder flexion, extension, abduction, external rotation (dynamometer placed immediately proximal to the elbow joint: anteriorly, posteriorly, and laterally, respectively); shoulder internal and external rotation (elbow at 90 degrees, dynamometer placed immediately proximal to the wrist joint, with the lower arm in mid pronation); and elbow flexion and extension (elbow at 90 degrees, dynamometer placed immediately proximal to the wrist joint: anteriorly and posteriorly, respectively, with the lower arm in full supination).
Timepoint [1] 304861 0
Tested at start of the study (T0), 4 weeks later after no intervention (T1), after a 4 - 6 week intervention (T2), 4 weeks after intervention is complete (T3)

Eligibility
Key inclusion criteria
Obtained and signed (self or legal carer) informed consent.
Completed Physician/Doctor medical clearance.
Diagnosis of ischaemic or haemorrhagic cerebrovascular accident as included in the World Health Organization ICD-10 classification system I61, I62.9, I63, and I64 categories, and at least 6 months post stroke
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent.
Pre-existing neurological conditions or previous brain trauma.
Range of movement limitation due to pain, previous trauma or pre-existing conditions.
Diagnosed psychological disorder at time of screening that is likely to prevent full participation.
Inability to correctly visualize a sample screen of the trial virtual reality computer game.
Unstable medical status
Upper limb lymphodema.
MRC Grade 0, 1, or 5 for shoulder flexion and elbow flexion power

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)
Participants recruited through clinicians at Burwood Brain Injury Rehabilitation Services and Princess Margaret Hospital in Christchurch NZ.

All participants receive treatment, allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This research can be seen as a preliminary/pilot study. A power calculation based on data of Prange et al. (2008) showed that using a within-subject design (Power calculation for a paired T-test) n=14 is sufficient to show clinically relevant changes in Fugl-Meyer scores. To account for dropout, 15 participants will be recruited.

A repeated measures ANOVA is used to analyse data to test for differences between all 4 time points.

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] 5443 0
New Zealand
State/province [1] 5443 0
Canterbury

Funding & Sponsors
Funding source category [1] 288036 0
Government body
Name [1] 288036 0
Ministry of Business Innovation and Employment (or as they were known at the time funding was given, Foundation for Research Science and Technology New Zealand)
Address [1] 288036 0
86 Customhouse Quay, Wellington 6011
Country [1] 288036 0
New Zealand
Primary sponsor type
Individual
Name
Kimberlee Jordan
Address
Callaghan Innovation (formerly Industrial Research Ltd)
PO Box 20028
Christchurch 8543
Country
New Zealand
Secondary sponsor category [1] 286759 0
Individual
Name [1] 286759 0
Marcus King
Address [1] 286759 0
Callaghan Innovation (formerly Industrial Research Ltd)
PO Box 20028
Christchurch 8543
Country [1] 286759 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289962 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 289962 0
Ministry of Health
PO Box 3877
Christchurch 8140
Ethics committee country [1] 289962 0
New Zealand
Date submitted for ethics approval [1] 289962 0
Approval date [1] 289962 0
17/03/2010
Ethics approval number [1] 289962 0
URB/10/02/004

Summary
Brief summary
The proposed research study will trial an arm skate embedded with a computer mouse (the Smart Skate) and virtual reality (VR) to establish the effectiveness as therapeutic table-top rehabilitation for the weakened upper limb of subjects who have suffered a stroke. VR is where a computer displays task-based ‘games’ that direct and prompt the user to exercise whilst providing feedback on performance. This will be done by comparing the outcomes of 4 - 6 weeks of 4 sessions per week Smart Skate + VR therapy in a group of people with hemiparesis as a result of stroke (chronic stroke participants). Assessment using an established physical outcome measure (the Fugl-Meyer assessment) and strength testing will occur before and after the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43274 0
Dr Kimberlee Jordan
Address 43274 0
Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 43274 0
New Zealand
Phone 43274 0
+64 3 3586824
Fax 43274 0
Email 43274 0
Kimberlee.Jordan@callaghaninnovation.govt.nz
Contact person for public queries
Name 43275 0
Dr Kimberlee Jordan
Address 43275 0
Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 43275 0
New Zealand
Phone 43275 0
+64 3 3586824
Fax 43275 0
Email 43275 0
Kimberlee.Jordan@callaghaninnovation.govt.nz
Contact person for scientific queries
Name 43276 0
Dr Kimberlee Jordan
Address 43276 0
Callaghan Innovation
PO Box 20028
Christchurch 8543
Country 43276 0
New Zealand
Phone 43276 0
+64 3 3586824
Fax 43276 0
Email 43276 0
Kimberlee.Jordan@callaghaninnovation.govt.nz

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