Virtual Reality for Post-Stroke Gait Rehabilitation

NCT07201974 | Recruiting

• 1 other identifier: MP-50-2026-2380
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Keywords

Rehabilitation; Intervention; Community Walking; Virtual Reality; Clinical care

Outcome Measures

Primary Outcomes (16)

• Feasibility: adherence to intervention - number of completed sessions

  Training logbook filled by clinicians

  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.

  Post-Intervention (week4)

• Feasibility: Number of participants recruited in each program

  Number of early discharged participants vs. outpatient program participants

  Pre-intervention (week0)

• Feasibility: Characteristics of stroke participants: age

  Collected via medical charts

  Pre-intervention (week 0)

• Feasibility: Characteristics of stroke participants: sex

  Collected via medical charts

  Pre-intervention (week 0)

• Feasibility: Characteristics of stroke participants: gender

  Collected via medical charts

  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.

  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.

  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.

  Pre-intervention (week 0)

• Feasibility: Characteristics of clinicians

  collected via paper-based questionnaire

  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.

  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.

  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").

  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.

  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.

  Post-intervention (Week4)

• Acceptability: Overall experience

  Investigated through open-ended questions

  Post-Intervention (Week4)

Study Arms (1)

VR training

EXPERIMENTAL

Participants will engage in a 4-week VR intervention that comprises of 1-hour training sessions, 2 times/week.

Other: Virtual Reality Training

Interventions

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.

VR training

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• McGill University: lead
• Jewish Rehabilitation Hospital: collaborator

Study Sites (1)

Jewish Rehabilitation Hospital

Laval, Quebec, H7V1R2, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Anouk Lamontagne, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anouk Lamontagne, PhD

CONTACT

450-688-9550; anouk.lamontagne@mcgill.ca

Myriamn Villeneuve, Mec

CONTACT

514-216-1295; myriam.villeneuve@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention study involving a single group, multiple-pre, multiple-post, sequential design

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 1, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: De-identified data will be deposited in a REDCap database and made available to collaborators. Data may also be made available to other researchers via an institutional data repository that will allow adhering to FAIR principles.

Locations

CA (1)