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Trial registered on ANZCTR
Registration number
ACTRN12611000858998
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
12/08/2011
Date last updated
12/08/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
Optimizing arm motor recovery in stroke
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Scientific title
In participants with chronic post-stroke upper limb hemiparesis, does training in a virtual compared to a similar physical environment result in better arm motor recovery
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Secondary ID [1]
262628
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke
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hemiparesis
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Condition category
Condition code
Stroke
268458
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0
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Ischaemic
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Physical Medicine / Rehabilitation
268461
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0
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Physiotherapy
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Stroke
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Multi-site study of effect of practice of reaching movements in virtual reality (VR) environments: Site 1 = 3D VR; Site 2 = 2D VR. Arm pointing movements are practiced in VR environment designed to resemble items on a shelf in the supermarket containing everyday products like juice, yogourt, peas and soda. One VR environment was created using three-dimensional software (3D VR) and the second VR environment was created using two-dimensional software (2D VR). Pointing targets were placed on two rows in the contralateral, central and ipsilateral arm workspace above and below shoulder height. In each VR, participants practiced pointing movements 72 times per one-hour session, 3 days a week for 4 weeks (12 sessions).
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Intervention code [1]
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Rehabilitation
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Comparator / control treatment
Practice of arm pointing movements in control environments - Site 1 = physical laboratory environment (PE); Site 2= physical home program (HP). Participants practiced pointing movements to six targets (numbered 1-6) in the PE and HP. Movements were the same except that practice was done in different settings and subjects in HP received no performance feedback. Subjects in the PE received performance feedback in the form of an auditory signal ('whoosh') from the computer if they used excessive trunk displaceemnt. Pointing
targets were placed on two rows in the contralateral, central and ipsilateral arm workspace above and below shoulder height. Participants practiced pointing movements 72 times per one-hour session, 3 days a week for 4 weeks (12 sessions).
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Control group
Active
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Outcomes
Primary outcome [1]
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Kinematics of movement pattern outcomes (elbow extension, shoulder horizontal adduction, shoulder flexion ranges of motion and trunk displacement). Kinematics will be recorded with a motion analysis system. Kinematics will be reconstructed based on marker movements placed on body segments and analyzed using custom software.
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Assessment method [1]
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Timepoint [1]
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Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
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Primary outcome [2]
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Motor performance outcome kinematics (endpoint precision, speed and trajectory straightness). Kinematics will be recorded with a motion analysis system. Kinematics will be reconstructed based on marker movements placed on body segments and analyzed using custom software.
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Assessment method [2]
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Timepoint [2]
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Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
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Secondary outcome [1]
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Clinical measures of upper limb motor impairment (Fugl-Meyer assessment, Reaching Performance Scale)
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Assessment method [1]
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Timepoint [1]
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Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
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Secondary outcome [2]
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Clinical measures of upper limb use in real life activities (Wolf Motor Function Test, Motor Activity Log).
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Assessment method [2]
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Timepoint [2]
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Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
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Eligibility
Key inclusion criteria
1) Single unilateral ischemic or hemorrhagic stroke 6-60 months previously;
2) Score of 3-6/7 on the arm subscale of the Chedoke-McMaster Stroke Assessment;
3) Aged between 40-80 years;
4) No other neurological, neuromuscular/ orthopaedic problems affecting the upper limb and trunk and
5) No significant attention deficits, neglect or apraxia
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Brainstem or cerebellar lesions
2) Difficulty in comprehending French and/or English
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site"
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation at each site was employed in the study. Subjects were stratified at baseline on basis of severity of upper limb motor impairment using Fugl-Meyer scores (±5 pts) and age (±5 years). They were matched and then randomly allocated to either PE/3D VR group (Site 1) or HP/2D VR group (Site 2). Randomization at each site was done by coin-toss.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/01/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
64
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Quebec
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Heart and Stroke Foundation of Canada
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Address [1]
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222 Queen Street, Suite 1402
Ottawa, Ontario K1P 5V9
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Country [1]
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Canada
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Primary sponsor type
Individual
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Name
Dr. Mindy F Levin
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Address
School of Physical and Occupational Therapy,
McGill University,
Davis House,
3654 Promenade Sir William Osler
Montreal, Quebec H3G 1Y5
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Country
Canada
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr. Heidi Sveistrup
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Address [1]
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School of Rehabilitation Sciences, Faculty of Health Sciences
University of Ottawa,
451 Smyth Road,
Ottawa, Ontario K1H 8M5
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Country [1]
266495
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Canada
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Center for Interdisciplinary Research in Rehabilitation of Greater Montreal
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Ethics committee address [1]
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2275, Laurier Avenue East
Montreal, Quebec H2H 2N8
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Ethics committee country [1]
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Canada
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Date submitted for ethics approval [1]
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22/08/2007
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Approval date [1]
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07/01/2008
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Ethics approval number [1]
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CRIR-319-0807
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Summary
Brief summary
The objective of this research is to compare the effects of training arm movements in four different environments where each environment offers a different level of motivation and feedback to the learner. We will also determine how learners with different initial movement and cognitive problems can use the information provided by each environment to improve their arm movement and whether this may be related to their own level of motivation. A physical therapist and psychologist will measure each peson's level of arm movement and cognitive ability. People will then be divivded according to whether their problems in each area are mild or moderate and then they will be randomly assigned to one of 4 treatment groups. Each group will practice arm movements to 6 different targets for 12 seesions. Two groups will practice movements in a virtual reality game like environment and two will practice in a physical environment. Three of the 4 groups(3D VR, 2D VR & PE) will receive feedback on how well they make arm movements. Before and after practice and at a 3 month follow-up period, we will record how each participant points to targets.
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Trial website
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Trial related presentations / publications
1. Lourenco CB, Subramanian SK, Sveistrup H, Levin MF (2010). Physical and virtual reality training environments for upper limb motor recovery in chronic stroke. Stroke; 41(7):e498.
2. Lourenco CB, Subramanian SK, Sveistrup H, Levin MF (2010). Motivation and practice environments for upper limb recovery in stroke. Physiother Can.; 62(S1):48.
3. Lourenco CB, Subramanian SK, Sveistrup H, Levin MF(2010). Effect of different training environments on upper limb motor recovery following stroke. Arch Phys Med Rehab.; 91(10):e31.
4. Subramanian SK, Lourenco CB, Sveistrup H, Levin MF (2011). Arm motor rehabilitation in chronic stroke: effects of two different training environments. Proceedings of Virtual Rehabilitation 2011, Zurich, June 27-29, 2011.
5.Subramanian SK, Lourenco CB, Chilingaryan G, Sveistrup H, Levin MF (2011).Randomized controlled trial of effect of virtual reality versus physical training environments on arm motor recovery in chronic stroke (submitted to 2nd Canadian Stroke Congress).
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr. Mindy F Levin
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Address
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Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5
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Country
16124
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Canada
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Phone
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1 514 398 3994
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Fax
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1 514 398 6360
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr. Mindy F Levin
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Address
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Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5
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Country
7052
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Canada
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Phone
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1 514 398 3994
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Fax
7052
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1 514 398 6360
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Responsiveness of the Reaching Performance Scale for Stroke.
2023
https://dx.doi.org/10.1016/j.apmr.2023.04.020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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