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NCT Number: NCT07201974

Virtual Reality for Post-Stroke Gait Rehabilitation

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • Subjects with comorbidities interfering with walking
  • Subjects with comorbidities interfering with visual perception
  • Subjects without medical clearance for exercise

Treatment and study plan

Virtual Reality Training

Other

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.

Primary outcomes

  1. Feasibility: adherence to intervention - number of completed sessions

    Time frame: 2x/week over the 4-week intervention

    Training logbook filled by clinicians

  2. 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.

  3. Feasibility: Number of participants recruited in each program

    Time frame: Pre-intervention (week0)

    Number of early discharged participants vs. outpatient program participants

  4. Feasibility: Characteristics of stroke participants: age

    Time frame: Pre-intervention (week 0)

    Collected via medical charts

  5. Feasibility: Characteristics of stroke participants: sex

    Time frame: Pre-intervention (week 0)

    Collected via medical charts

  6. Feasibility: Characteristics of stroke participants: gender

    Time frame: Pre-intervention (week 0)

    Collected via medical charts

  7. 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.

  8. 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.

  9. 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.

  10. Feasibility: Characteristics of clinicians

    Time frame: Pre-intervention (week0)

    collected via paper-based questionnaire

  11. 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.

  12. 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.

  13. 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").

  14. 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.

  15. 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.

  16. Acceptability: Overall experience

    Time frame: Post-Intervention (Week4)

    Investigated through open-ended questions

Study contacts

Contact information is provided by the study sponsor or research team.

Anouk Lamontagne, PhD

CONTACT

[email protected]

450-688-9550 ext. 84168

Myriamn Villeneuve, Mec

CONTACT

[email protected]

514-216-1295

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Jewish Rehabilitation Hospital

Registry information

Official study title

iWalk in VR: Integration of Virtual Reality-based Locomotor Rehabilitation in Clinical Care

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Oct 1, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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