Virtual Reality and Field Training to Enhance Community Walking After Stroke

• ClinicalTrials.gov Identifier: NCT04559373
• Recruitment Status: Not yet recruiting
• First Posted: September 22, 2020
• Last Update Posted: February 24, 2021
• Sponsor: McGill University
• Collaborators: Jewish Rehabilitation Hospital; Laval University; Integrated University Health and Social Services Center of the Capitale-Nationale
• Information provided by (Responsible Party): Anouk Lamontagne, McGill University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke	Other: Virtual Reality and Field Training (VRFT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Intervention study involving a single group, multiple-pre, multiple-post, sequential design.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Virtual Reality and Field Training Toolkit to Enhance Community Ambulation and Participation in Stroke Survivors
• Estimated Study Start Date: April 1, 2021
• Estimated Primary Completion Date: May 31, 2022
• Estimated Study Completion Date: August 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Post-intervention change in the Six Minute Walk Test (6MWT) [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   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.
2. Change in the Six Minute Walk Test (6MWT) at Follow-up [ Time Frame: Post-intervention (Week8) and Follow-up (Week12) ]
   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.

Secondary Outcome Measures :

1. Dynamic Gait Index [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   Developed to assess the likelihood of falling in older adults
2. 5m Walk Test [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   Assesses walking speed in meters per seconds over a short duration
3. Activities-Specific Balance Confidence Scale [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   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.
4. Trip Activity Log [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   Questionnaire to record the number of trips and walking-related activities in the community (e.g. outside home) 3 days preceding its administration
5. Environmental Analysis of Mobility Questionnaire [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   Self-reported tool to assess mobility problems due to the environment
6. Assessment of Life Habits (Life-H: mobility and community life domains) [ Time Frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12) ]
   Assesses mobility and community life habits based on the levels of accomplishment and assistance required as well as satisfaction

Other Outcome Measures:

1. Adherence to intervention [ 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 ]
   Training logbook filled by researchers/clinicians (virtual reality) and subjects (field training) component)
2. Safety of the intervention [ Time Frame: 3x/week over the 4-week intervention of the virtual reality component ]
   Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc).
3. Acceptability of the intervention [ Time Frame: Post-intervention (Week8) ]
   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.
4. Cadence [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   Cadence is the rate at which a person walks (steps per minute) and will be measured with the GaitRite system.
5. Step length [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   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.
6. Step duration [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   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.
7. Stance phase [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   Stance phase is the period of time when the foot is in contact with the ground (%) and will be measured with the GaitRite system.
8. Swing phase [ Time Frame: Pre-intervention (Week4) and post-intervention (Week8) ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Anouk Lamontagne, PhD; 514-938-4397; anouk.lamontagne@mcgill.ca

Contact: Andréanne Blanchette, PhD; 418-656-2131 ext 403579; andreanne.blanchette@fmed.ulaval.ca

Sponsors and Collaborators

McGill University

Jewish Rehabilitation Hospital

Laval University

Integrated University Health and Social Services Center of the Capitale-Nationale

Investigators

• Principal Investigator: Anouk Lamontagne, PhD; McGill University

More Information

• Responsible Party: Anouk Lamontagne, Associate Professor, McGill University
• ClinicalTrials.gov Identifier: NCT04559373
• Other Study ID Numbers: PJT-148917
• First Posted: September 22, 2020
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: De-identified individual participant data for all primary and secondary outcome measure will be made available.
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anouk Lamontagne, McGill University:

Aging; Biomechanics; Community ambulation; Intervention; Locomotion; Rehabilitation; Sensorimotor integration; Virtual reality

Additional relevant MeSH terms:

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