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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

hemiparesis

Condition category

Condition code

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Physiotherapy

Stroke

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]

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]

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]

Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)

Primary outcome [2]

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]

Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)

Secondary outcome [1]

Clinical measures of upper limb motor impairment (Fugl-Meyer assessment, Reaching Performance Scale)

Timepoint [1]

Before practice, after practice (5 weeks later), 3 month after post-practice assessment (follow up)

Secondary outcome [2]

Clinical measures of upper limb use in real life activities (Wolf Motor Function Test, Motor Activity Log).

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

28/01/2008

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]

Canada

State/province [1]

Quebec

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart and Stroke Foundation of Canada

Address [1]

222 Queen Street, Suite 1402
Ottawa, Ontario K1P 5V9

Country [1]

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]

Individual

Name [1]

Dr. Heidi Sveistrup

Address [1]

School of Rehabilitation Sciences, Faculty of Health Sciences
University of Ottawa,
451 Smyth Road,
Ottawa, Ontario K1H 8M5

Country [1]

Canada

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Center for Interdisciplinary Research in Rehabilitation of Greater Montreal

Ethics committee address [1]

2275, Laurier Avenue East
Montreal, Quebec H2H 2N8

Ethics committee country [1]

Canada

Date submitted for ethics approval [1]

22/08/2007

Approval date [1]

07/01/2008

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr. Mindy F Levin

Address

Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5

Country

Canada

Phone

1 514 398 3994

Fax

1 514 398 6360

mindy.levin@mcgill.ca

Contact person for scientific queries

Name

Dr. Mindy F Levin

Address

Schoool of Physical and Occupational Therapy,
McGill University,
Davis house,
3654 Promenade Sir William Osler,
Montreal, Quebec - H3G1Y5

Country

Canada

Phone

1 514 398 3994

Fax

1 514 398 6360

mindy.levin@mcgill.ca

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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Documents added automatically