iWalk in VR: Integration of Virtual Reality-based Locomotor Rehabilitation in Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility: adherence to intervention - number of completed sessions
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients with stroke referred by clinicians of the inpatient and outpatient stroke rehabilitation programs at the Jewish Rehabilitation Hospital (CISSS Laval) for mobility problems over a period of 6 months will be recruited. They will:
- •be aged between 40 and 74 years;
- •have normal/corrected visual and auditory acuity present;
- •present a first-ever supratentorial unilateral stroke of 1-24 weeks duration;
- •present the ability to walk independently with/without walking aids for at least 1 min at a speed of 0.4-0.9 m/s;
- •present intact or mildly affected cognitive function (MoCA scores ≥ 22/30);
- •present intact to moderately affected visual- perceptual function (positive scores on a max. of 3/6 tasks on the Behavioural Inattention Test).
排除标准
- •Subjects with comorbidities interfering with walking
- •Subjects with comorbidities interfering with visual perception
- •Subjects without medical clearance for exercise
结局指标
主要结局
Feasibility: adherence to intervention - number of completed sessions
时间窗: 2x/week over the 4-week intervention
Training logbook filled by clinicians
Feasibility: Characteristics of stroke participants: visual-perceptual function
时间窗: Pre-intervention (week 0)
Collected via medical charts. According to occupationnal therapy evaluations, visual-perceptual function is characterised as severely affected, moderately affected, mildly affected, or intact.
Feasibility: Sense of presence
时间窗: Post-Intervention (week4)
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").
Acceptability of the intervention
时间窗: Post-intervention (Week4)
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.
Feasibility: presence of adverse or undesirable effects during the intervention
时间窗: Post-Intervention (week4)
Assesses by systematically collecting any occurrence of adverse/unwanted events (falls, injuries, fatigue, etc). Collected with open-ended questions.
Feasibility: Number of participants recruited in each program
时间窗: Pre-intervention (week0)
Number of early discharged participants vs. outpatient program participants
Feasibility: Presence of cybersickness
时间窗: Post-Intervention (week4)
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.
Feasibility: Characteristics of stroke participants: age
时间窗: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: sex
时间窗: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: gender
时间窗: Pre-intervention (week 0)
Collected via medical charts
Feasibility: Characteristics of stroke participants: walking capacity
时间窗: Pre-intervention (week 0)
Collected via medical charts. According to physiotherapy evaluations, walking capacity is characterized as severely, moderately or mildly affected.
Feasibility: Characteristics of stroke participants: cognitive function
时间窗: Pre-intervention (week 0)
Collected via medical charts. According to occupationnal therapy evaluations, cognitive fonction is characterised as severely affected, moderately affected, mildly affected, or intact.
Feasibility: Characteristics of clinicians
时间窗: Pre-intervention (week0)
collected via paper-based questionnaire
Feasibility: Perceived mental and physical demands
时间窗: Post-Intervention (week4)
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.
Feasibility: Number of eligible vs. referred participants
时间窗: Post-intervention (week4)
Assessed using the number of participants referred to the study in comparison to the list of admitted patients in the targeted stroke programs.
Acceptability: Overall experience
时间窗: Post-Intervention (Week4)
Investigated through open-ended questions
次要结局
未报告次要终点
研究者
Anouk Lamontagne
Associate Professor
McGill University