Clinical trial NCT04559373: Virtual Reality and Field Training to Enhance Community Walking After Stroke
Official title: A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Aging
Biomechanics
Community ambulation
Intervention
Locomotion
Rehabilitation
Sensorimotor integration
Virtual reality
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Jewish Rehabilitation Hospital
name: Integrated University Health and Social Services Center of the Capitale-Nationale
name: Laval University
First posted: 2020-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention study involving a single group, multiple-pre, multiple-post, sequential design.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

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

Primary outcomes:
measure: Post-intervention change in the Six Minute Walk Test (6MWT)
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
measure: Change in the Six Minute Walk Test (6MWT) at Follow-up
timeFrame: Post-intervention (Week8) and Follow-up (Week12)
Secondary outcomes:
measure: Dynamic Gait Index
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
measure: 5m Walk Test
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
measure: Activities-Specific Balance Confidence Scale
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
measure: Trip Activity Log
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
measure: Environmental Analysis of Mobility Questionnaire
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
measure: Assessment of Life Habits (Life-H: mobility and community life domains)
timeFrame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
Other outcomes:
measure: Adherence to intervention
timeFrame: 3x/week over the 4-week intervention for the virtual reality component; 2x/week over the 4-week intervention for the field training component
measure: Safety of the intervention
timeFrame: 3x/week over the 4-week intervention of the virtual reality component
measure: Acceptability of the intervention
timeFrame: Post-intervention (Week8)
measure: Cadence
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
measure: Step length
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
measure: Step duration
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
measure: Stance phase
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
measure: Swing phase
timeFrame: Pre-intervention (Week4) and post-intervention (Week8)
Locations:
city: Laval
country: Canada
facility: Jewish Rehabilitation Hospital
state: Quebec
city: Québec
country: Canada
facility: Institut de réadaptation en déficience physique de Québec
Study officials:
affiliation: McGill University
name: Anouk Lamontagne, PhD
role: PRINCIPAL_INVESTIGATOR
References: