NCT04559373 Virtual Reality and Field Training to Enhance Community Walking After Stroke
| NCT ID | NCT04559373 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-04-01 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: * Subjects with comorbidities interfering with walking * Subjects with comorbidities interfering with visual perception * Subjects without medical clearance for exercise
Contact & Investigator
Anouk Lamontagne, PhD
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT04559373 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 74 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04559373 currently recruiting?
Yes, NCT04559373 is actively recruiting participants. Contact the research team at anouk.lamontagne@mcgill.ca for enrollment information.
Where is the NCT04559373 trial being conducted?
This trial is being conducted at Laval, Canada, Québec, Canada.
Who is sponsoring the NCT04559373 clinical trial?
NCT04559373 is sponsored by McGill University. The principal investigator is Anouk Lamontagne, PhD at McGill University. The trial plans to enroll 40 participants.
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