Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000710729
Ethics application status
Approved
Date submitted
26/06/2013
Date registered
28/06/2013
Date last updated
16/07/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality Rehabilitation After Stroke Study
Scientific title
Virtual reality (VR) training in a standing posture as an adjunct to conventional in-patient rehabilitation to improve balance for individuals post-stroke as compared to seated VR training.
Secondary ID [1] 282706 0
None
Universal Trial Number (UTN)
Trial acronym
VRRASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 289419 0
Balance, gait and functional independence. 289420 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289746 289746 0 0
Physiotherapy
Stroke 289747 289747 0 0
Haemorrhagic
Stroke 289748 289748 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Training was done with a virtual reality system (IREX) in a standing posture to work balance, reaching and mobility. Participants completed 10 sessions (roughly 1 hour long) which provided them with 10 to 33 minutes of actual playing time due to rests. Sessions were booked daily throughout the week for 2 consecutive weeks. Games were selected to challenge standing weight-bearing and transfer as well as controlled shifting of the centre of mass. For example, participants were in a virtual soccer net and were instructed to save the virtual soccer balls that appeared on the screen by leaning side to side and reaching to save the balls. Participants were supervised by a registered kinesiologist who ensured proper training levels and closely monitored participants by standing arms reach away from the physio belt around the participant’s waist at all times to ensure no falls. Daily VR training sheets were completed to monitor progression in the games, amount of time spent playing games as well as adherence to the program.
Intervention code [1] 287366 0
Rehabilitation
Comparator / control treatment
Participants in the control group completed daily (Monday-Friday) sessions for 2 weeks for a total of 10 sessions (each roughly 1 hour long) with the same virtual reality system (IREX) as the intervention group, but participated in a seated position. Interactions with virtual objects by participants in the control group did not challenge balance and was limited to movements that did not shift the base of seated support. Sessions were monitored by a registered kinesiologist to ensure limited movements but yet and enjoyable, safe time for participants. Daily VR training sheets were completed to monitor progression in the games, amount of time spent playing games as well as adherence to the program.
Control group
Active

Outcomes
Primary outcome [1] 289834 0
Timed Up & Go
Timepoint [1] 289834 0
Before training, immediately after the completion of training and 1-month after training.
Secondary outcome [1] 303343 0
Two Minute Walk Test
Timepoint [1] 303343 0
Before training, immediately after the completion of training and 1-month after training.
Secondary outcome [2] 303344 0
Chedoke McMaster Stroke Assessment
Timepoint [2] 303344 0
Before training, immediately after the completion of training and 1-month after training.

Eligibility
Key inclusion criteria
1) aged 18 or over;
2) admitted to the in-patient stroke rehabilitation program;
3) could stand unaided for 1-minute at the time of enrollment into the project
4) could provide informed consent.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) severe cognitive impairments (unable to follow instructions);
2) an unstable medical condition
3) vestibular deficits, vertigo or
4) seizure activity in the last 6 months

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)
The recruitment process involved the introduction of the study to a suitable patient by the admitting physician and/or primary care nurse. The patient then gave verbal permission to be contacted by the study’s research associate (RA) to hear further details about the project. Written consent was obtained after detailing the study’s protocol and requirements and the patient’s chart was consulted for relevant medical and demographical information. The participant's information was then sent through email to an off-site researcher for central randomisation. The group allocation was then only sent to the kinesiologist that would be doing the training.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization of the first 37 participants occurred using the coin flip method while the second half were additionally randomized using age and Berg Balance Scale score to minimize of group differences. Both the RA and the participants were blind to the study’s group allocation to safeguard against any potential bias.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2011
Actual
24/05/2011
Date of last participant enrolment
Anticipated
6/05/2013
Actual
12/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5153 0
Canada
State/province [1] 5153 0
Ontario

Funding & Sponsors
Funding source category [1] 287475 0
Charities/Societies/Foundations
Name [1] 287475 0
The Heart and Stroke Foundation of Ontario
Country [1] 287475 0
Canada
Funding source category [2] 287476 0
Other Collaborative groups
Name [2] 287476 0
Centre For Stroke Recovery
Country [2] 287476 0
Canada
Funding source category [3] 287477 0
Other Collaborative groups
Name [3] 287477 0
Tony & Elisabeth Graham
Country [3] 287477 0
Canada
Primary sponsor type
Individual
Name
Dr. Hillel Finestone
Address
Bruyere Research Institute
43 Bruyere St.
Ottawa, Ontario
K1N 5C8
Country
Canada
Secondary sponsor category [1] 286219 0
None
Name [1] 286219 0
Address [1] 286219 0
Country [1] 286219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289452 0
Research Ethics Board at Bruyere Continuing Care
Ethics committee address [1] 289452 0
43 Bruyere St.
Ottawa, Ontario
K1N 5C8
Ethics committee country [1] 289452 0
Canada
Date submitted for ethics approval [1] 289452 0
Approval date [1] 289452 0
10/07/2009
Ethics approval number [1] 289452 0

Summary
Brief summary
Virtual reality exercise therapy — similar to participating in a video game, only using the whole body — has been used for rehabilitation of stroke, spinal cord injury, Parkinson’s disease and traumatic brain injury. It has been shown to improve balance in patients with traumatic brain injuries and older adults. Studies of virtual reality training in stroke patients have shown similar benefits for balance and walking. The objective of this study is to compare the effects of training in a virtual environment in two positions (seated vs standing) while participants are also doing in-patient stroke rehabilitation. We hypothesize that virtual reality exercise therapy improves balance, weight bearing on the affected side, walking tolerance and certain aspects of function for those that train standing up. We also hypothesize that it is a safe and enjoyable activity for addition to the stroke rehabilitation program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40914 0
Dr Hillel Finestone
Address 40914 0
Department of Physical Medicine and Rehabilitation
Bruyere Continuing Care
43 Bruyere St
Ottawa, Ontario
K1N 5C8
Country 40914 0
Canada
Phone 40914 0
(+1-613-562-6262)
Fax 40914 0
Email 40914 0
[email protected]
Contact person for public queries
Name 40915 0
Hillel Finestone
Address 40915 0
Department of Physical Medicine and Rehabilitation
Bruyere Continuing Care
43 Bruyere St
Ottawa, Ontario
K1N 5C8
Country 40915 0
Canada
Phone 40915 0
(+1-613-562-6262)
Fax 40915 0
Email 40915 0
[email protected]
Contact person for scientific queries
Name 40916 0
Hillel Finestone
Address 40916 0
Department of Physical Medicine and Rehabilitation
Bruyere Continuing Care
43 Bruyere St
Ottawa, Ontario
K1N 5C8
Country 40916 0
Canada
Phone 40916 0
(+1-613-562-6262)
Fax 40916 0
Email 40916 0
[email protected]

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