Virtual Reality and Field Training to Enhance Community Walking After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04559373
• Other study ID #: PJT-148917
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: October 2023
• Source: McGill University
• Contact: Anouk Lamontagne, PhD
• Phone: 514-938-4397
• Email: anouk.lamontagne[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Jewish Rehabilitation Hospital	Laval	Quebec
Canada	Institut de réadaptation en déficience physique de Québec	Québec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University	Integrated University Health and Social Services Center of the Capitale-Nationale, Jewish Rehabilitation Hospital, Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)