An interventional study of Virtual Reality and Field Training (VRFT) in Stroke, sponsored by McGill University. Recruiting at 2 sites in Canada. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by McGill University · Not applicable, Interventional, and Supportive care
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Participants will engage in a 4-week VRFT intervention that comprises of 1-hour training sessions, 3 times/week.
Other: 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.
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.
Time frame: 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.
Time frame: Post-intervention (Week8) and Follow-up (Week12)
Dynamic Gait Index
Developed to assess the likelihood of falling in older adults
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
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)
Assesses mobility and community life habits based on the levels of accomplishment and assistance required as well as satisfaction
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Adherence to intervention
Training logbook filled by researchers/clinicians (virtual reality) and subjects (field training) component)
Time frame: 3x/week over the 4-week intervention for the virtual reality component; 2x/week over the 4-week intervention for the field training component
Safety of the intervention
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc).
Time frame: 3x/week over the 4-week intervention of the virtual reality component
Acceptability of the intervention
Assesses using the Technology Acceptance Model based Questionnaire (Tam-Q) based on the technology acceptance model, in which subjects 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.
Time frame: Post-intervention (Week8)
Cadence
Cadence is the rate at which a person walks (steps per minute) and will be measured with the GaitRite system.
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
Step length
Step length is the distance (in meters) from a point of contact with the ground of one foot to the following occurrence of the same point of contact with the other foot and will be measured with the GaitRite system.
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
Step duration
Step duration is the period of time (in seconds) taken for one step is measured from an event of one foot to the following occurrence of the same event with the other foot and will be measured with the GaitRite system.
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
Stance phase
Stance phase is the period of time when the foot is in contact with the ground (%) and will be measured with the GaitRite system.
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
Swing phase
Swing phase is the period of time when the foot is not in contact with the ground (%) and will be measured with the GaitRite system.
Time frame: Pre-intervention (Week4) and post-intervention (Week8)
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measure will be made available.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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