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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
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.
Jewish Rehabilitation Hospital
Laval, Quebec, Canada
RECRUITINGInstitut de réadaptation en déficience physique de Québec
Québec, Quebec, Canada
NOT_YET_RECRUITINGPost-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.
Time frame: 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.
Time frame: Post-intervention (Week8) and Follow-up (Week12)
Dynamic Gait Index
Developed to assess the likelihood of falling in older adults
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Week0), pre-intervention (Week4), post-intervention (Week8) and follow-up (Week12)
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