StrokeNCT07201974
Virtual Reality for Post-Stroke Gait Rehabilitation
A study testing Virtual Reality Training in people with Stroke, run by McGill University at 1 site in Canada.
Trial summary
The goal of this clinical trial is to: (1) implement and test the feasibility of a new VR-ODT intervention offered as part of usual therapy time of patients with a sub-acute stoke; (2) explore the acceptability of the intervention from the perspective of clinicians and patients and; (3) implement measures to optimize… Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2026to 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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible patients with stroke referred by clinicians of the inpatient and outpatient stroke rehabilitation programs at the Jewish Rehabilitation Hospital (CISSS Laval) for mobility problems over a period of 6 months will be recruited. They will:
- be aged between 40 and 74 years;
- have normal/corrected visual and auditory acuity present;
- present a first-ever supratentorial unilateral stroke of 1-24 weeks duration;
- present the ability to walk independently with/without walking aids for at least 1 min at a speed of 0.4-0.9 m/s;
- present intact or mildly affected cognitive function (MoCA scores ≥ 22/30);
- present intact to moderately affected visual- perceptual function (positive scores on a max. 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 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
About this study
Official title: iWalk in VR: Integration of Virtual Reality-based Locomotor Rehabilitation in Clinical Care
The goal of this clinical trial is to: (1) implement and test the feasibility of a new VR-ODT intervention offered as part of usual therapy time of patients with a sub-acute stoke; (2) explore the acceptability of the intervention from the perspective of clinicians and patients and; (3) implement measures to optimize the uptake and sustainability of the intervention within the clinical setting.
Participants will engage in a personalized VR-ODT training for 4 weeks (2X 1hr/week) targeting six well-established community walking demands related to (1) walking speed and (2) distance; (3) postural transitions; (4) obstacle avoidance; (5) dual-task walking and; (6) a combination of demands 1-5. For each demand, patients will progress through levels of increasing difficulty according to personalized goals and success criteria.
Read the detailed description
The project involves the VR-ODT set-up and intervention aimed at improving community walking in stroke survivors, to be implemented and tested within the clinical setting. The set-up comprises of a VR headset (HTC Vive) and an ODT (Infinadeck- to our knowledge the only one in Canada) allowing users to walk at self-selected speed in any direction (360 degrees) in a virtual environment representing a shopping mall in Montreal and nearby streets. Stroke individuals with an altered walking capacity (speed: 0.3 - 0.95m/s) will be recruited from the JRH in- and outpatient programs for 12 consecutive months.
Feasibility (Obj. 1) will be examined using the following measures collated post intervention: number of eligible vs. referred patients and treating clinicians involved; patient and clinician characteristics; adherence to the intervention and adverse events. Perceived mental and physical demands (NASA Tax Load Index), sense of presence (Single- Item Presence Questionnaire) and cybersickness (Simulator Sickness Questionnaire) will also be assessed. Acceptability (Obj. 2) patients and clinicians will be assessed using a Technology Acceptance Model Questionnaire that includes questions related to perceived ease of use and usefulness, as well as with open-ended questions. To optimize uptake and sustainability (Obj. 3), two clinicians (1 occupationnel therapist \& 1 physiotherapist) from the JRH stroke program will be trained as clinician-champions (CC) on using the VR-ODT intervention and supporting other clinicians with intervention delivery. The CC, in collaboration with the team, will generate instructional materials (written and video) that detail the intervention, targeted users and step-by-step procedures for clinical use. The CC will also be involved in demonstrations (X2) on the use of the intervention for clinicians. They will be the resource for any question or required assistance with the VR-ODT set-up \& intervention.
- Conditions
- Stroke
- Being tested
- Virtual Reality Training
- Keywords
- Rehabilitation, Intervention, Community Walking, Virtual Reality, Clinical care
- 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 TrainingOther
The VR intervention involves the intensive practice of community ambulation skills. The training sessions will be performed in a virtual environment. 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 |
|---|---|---|
| VR training | Experimental | Participants will engage in a 4-week VR intervention that comprises of 1-hour training sessions, 2 times/week. Receives: Other: Virtual Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: adherence to intervention - number of completed sessions
Training logbook filled by clinicians
Measured: 2x/week over the 4-week intervention
Feasibility: presence of adverse or undesirable effects during the intervention
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc). Collected with open-ended questions.
Measured: Post-Intervention (week4)
Feasibility: Number of participants recruited in each program
Number of early discharged participants vs. outpatient program participants
Measured: Pre-intervention (week0)
Feasibility: Characteristics of stroke participants: age
Collected via medical charts
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: sex
Collected via medical charts
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: gender
Collected via medical charts
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: walking capacity
Collected via medical charts. According to physiotherapy evaluations, walking capacity is characterized as severely, moderately or mildly affected.
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: cognitive function
Collected via medical charts. According to occupationnal therapy evaluations, cognitive fonction is characterised as severely affected, moderately affected, mildly affected, or intact.
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: visual-perceptual function
Collected via medical charts. According to occupationnal therapy evaluations, visual-perceptual function is characterised as severely affected, moderately affected, mildly affected, or intact.
Measured: Pre-intervention (week 0)
Feasibility: Characteristics of clinicians
collected via paper-based questionnaire
Measured: Pre-intervention (week0)
Feasibility: Number of eligible vs. referred participants
Assessed using the number of participants referred to the study in comparison to the list of admitted patients in the targeted stroke programs.
Measured: Post-intervention (week4)
Feasibility: Perceived mental and physical demands
Collected using the NASA Tax Load Index. It assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales.
Measured: Post-Intervention (week4)
Feasibility: Sense of presence
Collected with the Single-Item Presence Questionnaire, a brief measure used to assess a participant's sense of presence in a virtual environment. It consists of one question rated on a 7-point Likert scale, ranging from 1 ("not at all") to 7 ("completely").
Measured: Post-Intervention (week4)
Feasibility: Presence of cybersickness
Collected via the Simulator Sickness Questionnaire, used for assessing symptoms of motion or simulator sickness following exposure to virtual environments. It includes 16 symptoms rated on a 4-point scale from 0 ("none") to 3 ("severe"), covering nausea, oculomotor discomfort, and disorientation.
Measured: Post-Intervention (week4)
Acceptability of the intervention
Assesses using the Technology Acceptance Model based Questionnaire (Tam-Q) based on the technology acceptance model, in which participants (patients and cliniciens) will rate their perception on each dimension using a visual analog scale ranging from 0-56, with higher score representing higher acceptance to the intervention.
Measured: Post-intervention (Week4)
Acceptability: Overall experience
Investigated through open-ended questions
Measured: Post-Intervention (Week4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 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
- Responsible party
- Principal investigator, Anouk Lamontagne, McGill University
- Investigators
- Anouk Lamontagne, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201974
- Sponsor's protocol ID
- MP-50-2026-2380
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2025
- Last updated
- 20 Mar 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iWalk in VR: Integration of Virtual Reality-based Locomotor Rehabilitation in Clinical Care
- ClinicalTrials.gov ID
- NCT07201974
- Acronym / sponsor ID
- MP-50-2026-2380
- Conditions
- Stroke
- Keywords
- Rehabilitation, Intervention, Community Walking, Virtual Reality, Clinical care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Jewish Rehabilitation Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Oct 2025 (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.
The goal of this clinical trial is to: (1) implement and test the feasibility of a new VR-ODT intervention offered as part of usual therapy time of patients with a sub-acute stoke; (2) explore the acceptability of the intervention from the perspective of clinicians and patients and; (3) implement measures to optimize the uptake and sustainability of the intervention within the clinical setting.
Participants will engage in a personalized VR-ODT training for 4 weeks (2X 1hr/week) targeting six well-established community walking demands related to (1) walking speed and (2) distance; (3) postural transitions; (4) obstacle avoidance; (5) dual-task walking and; (6) a combination of demands 1-5. For each demand, patients will progress through levels of increasing difficulty according to personalized goals and success criteria.
Detailed description
The project involves the VR-ODT set-up and intervention aimed at improving community walking in stroke survivors, to be implemented and tested within the clinical setting. The set-up comprises of a VR headset (HTC Vive) and an ODT (Infinadeck- to our knowledge the only one in Canada) allowing users to walk at self-selected speed in any direction (360 degrees) in a virtual environment representing a shopping mall in Montreal and nearby streets. Stroke individuals with an altered walking capacity (speed: 0.3 - 0.95m/s) will be recruited from the JRH in- and outpatient programs for 12 consecutive months.
Feasibility (Obj. 1) will be examined using the following measures collated post intervention: number of eligible vs. referred patients and treating clinicians involved; patient and clinician characteristics; adherence to the intervention and adverse events. Perceived mental and physical demands (NASA Tax Load Index), sense of presence (Single- Item Presence Questionnaire) and cybersickness (Simulator Sickness Questionnaire) will also be assessed. Acceptability (Obj. 2) patients and clinicians will be assessed using a Technology Acceptance Model Questionnaire that includes questions related to perceived ease of use and usefulness, as well as with open-ended questions. To optimize uptake and sustainability (Obj. 3), two clinicians (1 occupationnel therapist \& 1 physiotherapist) from the JRH stroke program will be trained as clinician-champions (CC) on using the VR-ODT intervention and supporting other clinicians with intervention delivery. The CC, in collaboration with the team, will generate instructional materials (written and video) that detail the intervention, targeted users and step-by-step procedures for clinical use. The CC will also be involved in demonstrations (X2) on the use of the intervention for clinicians. They will be the resource for any question or required assistance with the VR-ODT set-up \& intervention.
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 |
|---|---|---|
| VR training | Experimental | Other: Virtual Reality TrainingParticipants will engage in a 4-week VR intervention that comprises of 1-hour training sessions, 2 times/week. |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible patients with stroke referred by clinicians of the inpatient and outpatient stroke rehabilitation programs at the Jewish Rehabilitation Hospital (CISSS Laval) for mobility problems over a period of 6 months will be recruited. They will:
- be aged between 40 and 74 years;
- have normal/corrected visual and auditory acuity present;
- present a first-ever supratentorial unilateral stroke of 1-24 weeks duration;
- present the ability to walk independently with/without walking aids for at least 1 min at a speed of 0.4-0.9 m/s;
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 TrainingThe VR intervention involves the intensive practice of community ambulation skills. The training sessions will be performed in a virtual environment. 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 | VR training |
Primary outcome
Feasibility: adherence to intervention - number of completed sessions
Time frame: 2x/week over the 4-week intervention
Training logbook filled by clinicians
Feasibility: presence of adverse or undesirable effects during the intervention
Time frame: Post-Intervention (week4)
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc). Collected with open-ended questions.
Feasibility: Number of participants recruited in each program
Time frame: Pre-intervention (week0)
Number of early discharged participants vs. outpatient program participants
Feasibility: Characteristics of stroke participants: age
Time frame: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: sex
Time frame: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: gender
Time frame: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: walking capacity
Time frame: Pre-intervention (week 0)
Collected via medical charts. According to physiotherapy evaluations, walking capacity is characterized as severely, moderately or mildly affected.
Feasibility: Characteristics of stroke participants: cognitive function
Time frame: Pre-intervention (week 0)
Collected via medical charts. According to occupationnal therapy evaluations, cognitive fonction is characterised as severely affected, moderately affected, mildly affected, or intact.
Feasibility: Characteristics of stroke participants: visual-perceptual function
Time frame: Pre-intervention (week 0)
Collected via medical charts. According to occupationnal therapy evaluations, visual-perceptual function is characterised as severely affected, moderately affected, mildly affected, or intact.
Feasibility: Characteristics of clinicians
Time frame: Pre-intervention (week0)
collected via paper-based questionnaire
Feasibility: Number of eligible vs. referred participants
Time frame: Post-intervention (week4)
Assessed using the number of participants referred to the study in comparison to the list of admitted patients in the targeted stroke programs.
Feasibility: Perceived mental and physical demands
Time frame: Post-Intervention (week4)
Collected using the NASA Tax Load Index. It assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales.
Feasibility: Sense of presence
Time frame: Post-Intervention (week4)
Collected with the Single-Item Presence Questionnaire, a brief measure used to assess a participant's sense of presence in a virtual environment. It consists of one question rated on a 7-point Likert scale, ranging from 1 ("not at all") to 7 ("completely").
Feasibility: Presence of cybersickness
Time frame: Post-Intervention (week4)
Collected via the Simulator Sickness Questionnaire, used for assessing symptoms of motion or simulator sickness following exposure to virtual environments. It includes 16 symptoms rated on a 4-point scale from 0 ("none") to 3 ("severe"), covering nausea, oculomotor discomfort, and disorientation.
Acceptability of the intervention
Time frame: Post-intervention (Week4)
Assesses using the Technology Acceptance Model based Questionnaire (Tam-Q) based on the technology acceptance model, in which participants (patients and cliniciens) will rate their perception on each dimension using a visual analog scale ranging from 0-56, with higher score representing higher acceptance to the intervention.
Acceptability: Overall experience
Time frame: Post-Intervention (Week4)
Investigated through open-ended questions
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 20 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measure will be made available.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training in people with Stroke, run by McGill University at 1 site 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 7 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (450-688-9550 ext. 84168, anouk.lamontagne@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: adherence to intervention - number of completed sessions (time frame: 2x/week over the 4-week intervention). The study lists 16 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 20 Mar 2026.