The goal of this clinical trial is to: (1) implement and test the feasibility of a new VR-ODT intervention offered as part of usual therapy time of patients with a sub-acute stoke; (2) explore the acceptability of the intervention from the perspective of clinicians and patients and; (3) implement measures to optimize the uptake and sustainability of the intervention within the clinical setting. Participants will engage in a personalized VR-ODT training for 4 weeks (2X 1hr/week) targeting six well-established community walking demands related to (1) walking speed and (2) distance; (3) postural transitions; (4) obstacle avoidance; (5) dual-task walking and; (6) a combination of demands 1-5. For each demand, patients will progress through levels of increasing difficulty according to personalized goals and success criteria.
The project involves the VR-ODT set-up and intervention aimed at improving community walking in stroke survivors, to be implemented and tested within the clinical setting. The set-up comprises of a VR headset (HTC Vive) and an ODT (Infinadeck- to our knowledge the only one in Canada) allowing users to walk at self-selected speed in any direction (360 degrees) in a virtual environment representing a shopping mall in Montreal and nearby streets. Stroke individuals with an altered walking capacity (speed: 0.3 - 0.95m/s) will be recruited from the JRH in- and outpatient programs for 12 consecutive months. Feasibility (Obj. 1) will be examined using the following measures collated post intervention: number of eligible vs. referred patients and treating clinicians involved; patient and clinician characteristics; adherence to the intervention and adverse events. Perceived mental and physical demands (NASA Tax Load Index), sense of presence (Single- Item Presence Questionnaire) and cybersickness (Simulator Sickness Questionnaire) will also be assessed. Acceptability (Obj. 2) patients and clinicians will be assessed using a Technology Acceptance Model Questionnaire that includes questions related to perceived ease of use and usefulness, as well as with open-ended questions. To optimize uptake and sustainability (Obj. 3), two clinicians (1 occupationnel therapist \& 1 physiotherapist) from the JRH stroke program will be trained as clinician-champions (CC) on using the VR-ODT intervention and supporting other clinicians with intervention delivery. The CC, in collaboration with the team, will generate instructional materials (written and video) that detail the intervention, targeted users and step-by-step procedures for clinical use. The CC will also be involved in demonstrations (X2) on the use of the intervention for clinicians. They will be the resource for any question or required assistance with the VR-ODT set-up \& intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
The VR intervention involves the intensive practice of community ambulation skills. The training sessions will be performed in a virtual environment. 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
Feasibility: adherence to intervention - number of completed sessions
Training logbook filled by clinicians
Time frame: 2x/week over the 4-week intervention
Feasibility: presence of adverse or undesirable effects during the intervention
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc). Collected with open-ended questions.
Time frame: Post-Intervention (week4)
Feasibility: Number of participants recruited in each program
Number of early discharged participants vs. outpatient program participants
Time frame: Pre-intervention (week0)
Feasibility: Characteristics of stroke participants: age
Collected via medical charts
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: sex
Collected via medical charts
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: gender
Collected via medical charts
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: walking capacity
Collected via medical charts. According to physiotherapy evaluations, walking capacity is characterized as severely, moderately or mildly affected.
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: cognitive function
Collected via medical charts. According to occupationnal therapy evaluations, cognitive fonction is characterised as severely affected, moderately affected, mildly affected, or intact.
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of stroke participants: visual-perceptual function
Collected via medical charts. According to occupationnal therapy evaluations, visual-perceptual function is characterised as severely affected, moderately affected, mildly affected, or intact.
Time frame: Pre-intervention (week 0)
Feasibility: Characteristics of clinicians
collected via paper-based questionnaire
Time frame: Pre-intervention (week0)
Feasibility: Number of eligible vs. referred participants
Assessed using the number of participants referred to the study in comparison to the list of admitted patients in the targeted stroke programs.
Time frame: Post-intervention (week4)
Feasibility: Perceived mental and physical demands
Collected using the NASA Tax Load Index. It assesses work load on five 7-point scales. Increments of high, medium and low estimates for each point result in 21 gradations on the scales.
Time frame: Post-Intervention (week4)
Feasibility: Sense of presence
Collected with the Single-Item Presence Questionnaire, a brief measure used to assess a participant's sense of presence in a virtual environment. It consists of one question rated on a 7-point Likert scale, ranging from 1 ("not at all") to 7 ("completely").
Time frame: Post-Intervention (week4)
Feasibility: Presence of cybersickness
Collected via the Simulator Sickness Questionnaire, used for assessing symptoms of motion or simulator sickness following exposure to virtual environments. It includes 16 symptoms rated on a 4-point scale from 0 ("none") to 3 ("severe"), covering nausea, oculomotor discomfort, and disorientation.
Time frame: Post-Intervention (week4)
Acceptability of the intervention
Assesses using the Technology Acceptance Model based Questionnaire (Tam-Q) based on the technology acceptance model, in which participants (patients and cliniciens) 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.
Time frame: Post-intervention (Week4)
Acceptability: Overall experience
Investigated through open-ended questions
Time frame: Post-Intervention (Week4)
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