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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
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
Secondary ID [1] 262628 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 268325 0
hemiparesis 270484 0
Condition category
Condition code
Stroke 268458 268458 0 0
Ischaemic
Physical Medicine / Rehabilitation 268461 268461 0 0
Physiotherapy
Stroke 270641 270641 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 266977 0
Rehabilitation
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).
Control group
Active

Outcomes
Primary outcome [1] 269214 0
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.
Timepoint [1] 269214 0
Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
Primary outcome [2] 269215 0
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.
Timepoint [2] 269215 0
Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
Secondary outcome [1] 279133 0
Clinical measures of upper limb motor impairment (Fugl-Meyer assessment, Reaching Performance Scale)
Timepoint [1] 279133 0
Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)
Secondary outcome [2] 279134 0
Clinical measures of upper limb use in real life activities (Wolf Motor Function Test, Motor Activity Log).
Timepoint [2] 279134 0
Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)

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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Brainstem or cerebellar lesions
2) Difficulty in comprehending French and/or English

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)
allocation involved contacting the holder of the allocation schedule who was "off-site"
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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] 3723 0
Canada
State/province [1] 3723 0
Quebec

Funding & Sponsors
Funding source category [1] 267450 0
Charities/Societies/Foundations
Name [1] 267450 0
Heart and Stroke Foundation of Canada
Address [1] 267450 0
222 Queen Street, Suite 1402
Ottawa, Ontario K1P 5V9
Country [1] 267450 0
Canada
Primary sponsor type
Individual
Name
Dr. Mindy F Levin
Address
School of Physical and Occupational Therapy,
McGill University,
Davis House,
3654 Promenade Sir William Osler
Montreal, Quebec H3G 1Y5
Country
Canada
Secondary sponsor category [1] 266495 0
Individual
Name [1] 266495 0
Dr. Heidi Sveistrup
Address [1] 266495 0
School of Rehabilitation Sciences, Faculty of Health Sciences
University of Ottawa,
451 Smyth Road,
Ottawa, Ontario K1H 8M5
Country [1] 266495 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269416 0
Center for Interdisciplinary Research in Rehabilitation of Greater Montreal
Ethics committee address [1] 269416 0
2275, Laurier Avenue East
Montreal, Quebec H2H 2N8
Ethics committee country [1] 269416 0
Canada
Date submitted for ethics approval [1] 269416 0
22/08/2007
Approval date [1] 269416 0
07/01/2008
Ethics approval number [1] 269416 0
CRIR-319-0807

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.
Trial website
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).
Public notes

Contacts
Principal investigator
Name 32877 0
Address 32877 0
Country 32877 0
Phone 32877 0
Fax 32877 0
Email 32877 0
Contact person for public queries
Name 16124 0
Dr. Mindy F Levin
Address 16124 0
Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5
Country 16124 0
Canada
Phone 16124 0
1 514 398 3994
Fax 16124 0
1 514 398 6360
Email 16124 0
mindy.levin@mcgill.ca
Contact person for scientific queries
Name 7052 0
Dr. Mindy F Levin
Address 7052 0
Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5
Country 7052 0
Canada
Phone 7052 0
1 514 398 3994
Fax 7052 0
1 514 398 6360
Email 7052 0
mindy.levin@mcgill.ca

No information has been provided regarding IPD availability
Summary results
No Results