Stroke Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish Rehabilitation Hospital | Laval | Quebec |
Canada | Institut de réadaptation en déficience physique de Québec | Québec |
Lead Sponsor | Collaborator |
---|---|
McGill University | Integrated University Health and Social Services Center of the Capitale-Nationale, Jewish Rehabilitation Hospital, Laval University |
Canada,
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) |
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