Virtual Reality and Field Training to Enhance Community Walking After Stroke

A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Virtual Reality and Field Training (VRFT)

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anouk Lamontagne, PhD; Phone Number: 514-938-4397; Email: anouk.lamontagne@mcgill.ca
• Study Contact Backup: Name: Andréanne Blanchette, PhD; Phone Number: 403579 418-656-2131; Email: andreanne.blanchette@fmed.ulaval.ca

Study Locations

• Canada
  • Québec, Canada, G1W 1P7
    • Not yet recruiting
    • Institut de réadaptation en déficience physique de Québec
    • Contact: Andréanne Blanchette, PhD; Phone Number: 403579 418-656-2131; Email: andreanne.blanchette@fmed.ulaval.ca
  • Quebec
    • Laval, Quebec, Canada, H7V1R2
      • Recruiting
      • Jewish Rehabilitation Hospital
      • Contact: Anouk Lamontagne, PhD; Phone Number: 84168 450-688-9550; Email: anouk.lamontagne@mcgill.ca
      • Contact: Vira Rose; Phone Number: 84300 450-688-9550; Email: vrose_hjr@ssss.gouv.qc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality and Field Practice Training (VRFT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Post-intervention (Week8) and Follow-up (Week12)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic Gait Index	Developed to assess the likelihood of falling in older adults	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	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.	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	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	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	Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to intervention	Training logbook filled by researchers/clinicians (virtual reality) and subjects (field training) component)	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).	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.	Post-intervention (Week8)
Cadence	Cadence is the rate at which a person walks (steps per minute) and will be measured with the GaitRite system.	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.	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.	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.	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.	Pre-intervention (Week4) and post-intervention (Week8)

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Laval University; Jewish Rehabilitation Hospital; Integrated University Health and Social Services Center of the Capitale-Nationale
• Investigators: Principal Investigator: Anouk Lamontagne, PhD, McGill University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Aging; Biomechanics; Intervention; Virtual reality; Locomotion; Community ambulation; Sensorimotor integration
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PJT-148917

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measure will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months of study completion
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No