StrokeNCT04559373
Virtual Reality and Field Training to Enhance Community Walking After Stroke
A study testing Virtual Reality and Field Training (VRFT) in people with Stroke, run by McGill University at 2 sites in Canada.
Trial summary
While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality and Field Training (VRFT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with chronic stroke and persistent deficits in walking / visual-perceptual / cognitive capacities. They can be male or female, aged from 40 to 74 years, with normal/corrected visual and auditory acuity, and present with:
- First-ever supratentorial unilateral stroke 9-24 months ago (such chronicity will ensure steady-state mobility without long-term disuse-related changes
- Mild-to-moderate hemiparesis (Chedoke McMaster Stoke Assessment stages 4/7-6/7 on postural control, leg \& foot)
- Ability to walk independently with/without walking aids for at least 1 min at 0.4-0.9 m/s (such a speed range indicates mobility not sufficient for functional community ambulation: shopping ~1.1m/s, street crossing ~1.2 m/s)
- Intact or mildly affected cognitive function (Montreal Cognitive Assessment scores ≥ 22/30)
- Intact to moderately affected visual-perceptual function (positive scores on a maximum of 3/6 tasks on the Behavioural Inattention Test)
Who cannot join
- Subjects with comorbidities interfering with walking
- Subjects with comorbidities interfering with visual perception
- Subjects without medical clearance for exercise
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Jewish Rehabilitation Hospital
Laval, Quebec, H7V1R2
Anouk Lamontagne, PhD, 450-688-9550 ext. 84168, anouk.lamontagne@mcgill.ca
Vira Rose, 450-688-9550 ext. 84300, vrose_hjr@ssss.gouv.qc.ca
- Not yet recruiting
Institut de réadaptation en déficience physique de Québec
Québec, Quebec, G1W 1P7
Andréanne Blanchette, PhD, 418-656-2131 ext. 403579, andreanne.blanchette@fmed.ulaval.ca
About this study
Official title: A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors
While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to enhance community ambulation and participation in stroke survivors discharged from rehabilitation.
The aims are to: (1) Assess feasibility, acceptability, safety and adherence of the intervention in stroke survivors; and (2) Examine the extent to which post-intervention changes in functional walking and participation to community walking vary according to walking, cognitive and visual-perceptual abilities.
The investigators will use a virtual environment prototype simulating a shopping mall and surrounding streets, in which participants will interact using VR goggles and game controllers. Scenarios of increasing levels of complexity will be introduced. This intervention study involves a single group, multiple pre- multiple post- study design where chronic stroke participants will engage in a 4-week training program. The program will include VR training sessions performed in the clinical setting (3/week) and practice of community ambulation skills while supervised by family/caregivers (2/week). Participants will be assessed on measures of functional walking, balance \& mobility and participation to community walking. Adherence, safety and acceptability will be documented. This study will generate foundation knowledge on the response to the intervention based on individual capacities.
Read the detailed description
Ambulating in community environments requires the skills to cope with multiple, simultaneous dimensions such as walking speed and distance, etc. Such skills remain compromised in the majority of stroke survivors due to insufficient or lack of targeted practice. The investigators propose to test a new, individually-tailored intervention, developed by the research team, grounded in best evidence in community ambulation, principles of motor learning and participatory action research. This unique intervention will combine virtual reality (VR) and field training practice to optimize learning that can be generalized to daily walking activities.
Participants will engage in the 4-week, individually-tailored intervention that comprises of supervised VR training sessions (3 times/week) performed in the clinical setting. VR sessions will be completed by field training assignments. Subjects will be assessed twice prior to the intervention, immediately after the intervention and at follow up.
Generalized estimating equations will be used to compare changes in main and secondary outcomes across time points, with each personal factor of interest (e.g. walking capacity, visual-perceptual function, and cognitive function) analyzed individually while adjusting for age. Outcomes on adherence, safety and acceptability will be analyzed with descriptive statistics.
Required sample size was estimated based on Green's rule (effect size=0.5, power=80%, α=0.05) with a variance inflation factor assuming moderate within-subject correlations for 3 post-baseline measurement time points. This yields a sample size of 30. Assuming a worst-case scenario of 30% attrition rate, a total of 40 stroke subjects (20/site) will be recruited.
- Conditions
- Stroke
- Being tested
- Virtual Reality and Field Training (VRFT)
- Keywords
- Aging, Biomechanics, Community ambulation, Intervention, Locomotion, Rehabilitation, Sensorimotor integration, Virtual reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality and Field Training (VRFT)Other
The VRFT intervention involves the intensive practice of community ambulation skills. Some of the training sessions will be performed in a virtual environment, while others will consist of field training exercises in the community. During the intervention, stroke participants will be invited to practice different dimensions of community ambulation, such as postural transitions, avoiding other pedestrians, dual-task walking, etc.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality and Field Practice Training (VRFT) | Experimental | Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week. Receives: Other: Virtual Reality and Field Training (VRFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention change in the Six Minute Walk Test (6MWT)
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: Pre-intervention (Week4) and post-intervention (Week8)
Change in the Six Minute Walk Test (6MWT) at Follow-up
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Measured: Post-intervention (Week8) and Follow-up (Week12)
Secondary outcomes (6)
Dynamic Gait Index
Developed to assess the likelihood of falling in older adults
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
5m Walk Test
Assesses walking speed in meters per seconds over a short duration
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Activities-Specific Balance Confidence Scale
16-item self-reported measure of balance confidence performing various activities without losing balance or experiencing a sense of unsteadiness. Items are rated on a 0%-100% response scale, with a score of 0 representing no confidence and a score of 100 representing complete confidence.
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Trip Activity Log
Questionnaire to record the number of trips and walking-related activities in the community (e.g. outside home) 3 days preceding its administration
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Environmental Analysis of Mobility Questionnaire
Self-reported tool to assess mobility problems due to the environment
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Assessment of Life Habits (Life-H: mobility and community life domains)
Assesses mobility and community life habits based on the levels of accomplishment and assistance required as well as satisfaction
Measured: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start1 Apr 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention study involving a single group, multiple-pre, multiple-post, sequential design.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, Integrated University Health and Social Services Center of the Capitale-Nationale, Laval University
- Responsible party
- Principal investigator, Anouk Lamontagne, McGill University
- Investigators
- Anouk Lamontagne, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559373
- Sponsor's protocol ID
- PJT-148917
- Status last verified
- Feb 2026
- First submitted
- 6 Jul 2020
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measure will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors
- ClinicalTrials.gov ID
- NCT04559373
- Acronym / sponsor ID
- PJT-148917
- Conditions
- Stroke
- Keywords
- Aging, Biomechanics, Community ambulation, Intervention, Locomotion, Rehabilitation, Sensorimotor integration, Virtual reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital, Integrated University Health and Social Services Center of the Capitale-Nationale, Laval University
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While stroke survivors discharged from rehabilitation present with some recovery in mobility, their ability to ambulate in the community remains limited. The investigators propose to test a novel, low-cost, intensive and individually tailored intervention that combines virtual reality (VR) and field training to enhance community ambulation and participation in stroke survivors discharged from rehabilitation.
The aims are to: (1) Assess feasibility, acceptability, safety and adherence of the intervention in stroke survivors; and (2) Examine the extent to which post-intervention changes in functional walking and participation to community walking vary according to walking, cognitive and visual-perceptual abilities.
The investigators will use a virtual environment prototype simulating a shopping mall and surrounding streets, in which participants will interact using VR goggles and game controllers. Scenarios of increasing levels of complexity will be introduced. This intervention study involves a single group, multiple pre- multiple post- study design where chronic stroke participants will engage in a 4-week training program. The program will include VR training sessions performed in the clinical setting (3/week) and practice of community ambulation skills while supervised by family/caregivers (2/week). Participants will be assessed on measures of functional walking, balance \& mobility and participation to community walking. Adherence, safety and acceptability will be documented. This study will generate foundation knowledge on the response to the intervention based on individual capacities.
Detailed description
Ambulating in community environments requires the skills to cope with multiple, simultaneous dimensions such as walking speed and distance, etc. Such skills remain compromised in the majority of stroke survivors due to insufficient or lack of targeted practice. The investigators propose to test a new, individually-tailored intervention, developed by the research team, grounded in best evidence in community ambulation, principles of motor learning and participatory action research. This unique intervention will combine virtual reality (VR) and field training practice to optimize learning that can be generalized to daily walking activities.
Participants will engage in the 4-week, individually-tailored intervention that comprises of supervised VR training sessions (3 times/week) performed in the clinical setting. VR sessions will be completed by field training assignments. Subjects will be assessed twice prior to the intervention, immediately after the intervention and at follow up.
Generalized estimating equations will be used to compare changes in main and secondary outcomes across time points, with each personal factor of interest (e.g. walking capacity, visual-perceptual function, and cognitive function) analyzed individually while adjusting for age. Outcomes on adherence, safety and acceptability will be analyzed with descriptive statistics.
Required sample size was estimated based on Green's rule (effect size=0.5, power=80%, α=0.05) with a variance inflation factor assuming moderate within-subject correlations for 3 post-baseline measurement time points. This yields a sample size of 30. Assuming a worst-case scenario of 30% attrition rate, a total of 40 stroke subjects (20/site) will be recruited.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention study involving a single group, multiple-pre, multiple-post, sequential design.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality and Field Practice Training (VRFT) | Experimental | Other: Virtual Reality and Field Training (VRFT)Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- People with chronic stroke and persistent deficits in walking / visual-perceptual / cognitive capacities. They can be male or female, aged from 40 to 74 years, with normal/corrected visual and auditory acuity, and present with:
- First-ever supratentorial unilateral stroke 9-24 months ago (such chronicity will ensure steady-state mobility without long-term disuse-related changes
- Mild-to-moderate hemiparesis (Chedoke McMaster Stoke Assessment stages 4/7-6/7 on postural control, leg \& foot)
- Ability to walk independently with/without walking aids for at least 1 min at 0.4-0.9 m/s (such a speed range indicates mobility not sufficient for functional community ambulation: shopping ~1.1m/s, street crossing ~1.2 m/s)
- Intact or mildly affected cognitive function (Montreal Cognitive Assessment scores ≥ 22/30)
Key exclusion criteria (3 listed)
- Subjects with comorbidities interfering with walking
- Subjects with comorbidities interfering with visual perception
- Subjects without medical clearance for exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality and Field Training (VRFT)The VRFT intervention involves the intensive practice of community ambulation skills. Some of the training sessions will be performed in a virtual environment, while others will consist of field training exercises in the community. During the intervention, stroke participants will be invited to practice different dimensions of community ambulation, such as postural transitions, avoiding other pedestrians, dual-task walking, etc. | Other | Virtual Reality and Field Practice Training (VRFT) |
Primary outcome
Post-intervention change in the Six Minute Walk Test (6MWT)
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Change in the Six Minute Walk Test (6MWT) at Follow-up
Time frame: Post-intervention (Week8) and Follow-up (Week12)
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
6 secondary outcomes
Dynamic Gait Index
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
5m Walk Test
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Activities-Specific Balance Confidence Scale
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Trip Activity Log
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Environmental Analysis of Mobility Questionnaire
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Assessment of Life Habits (Life-H: mobility and community life domains)
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be made available.
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anouk Lamontagne, PhD principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Field Training (VRFT) in people with Stroke, run by McGill University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anouk Lamontagne, PhD (514-938-4397, anouk.lamontagne@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-intervention change in the Six Minute Walk Test (6MWT) (time frame: Pre-intervention (Week4) and post-intervention (Week8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.