Идёт набор NCT07201974

Virtual Reality for Post-Stroke Gait Rehabilitation

Без фазы С лечением Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Virtual Reality Training.
Кому может быть актуально: Состояния в реестре: Stroke. Базовые параметры: 40 лет — 84 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

iWalk in VR: Integration of Virtual Reality-based Locomotor Rehabilitation in Clinical Care

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Virtual Reality Training
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.

Первичные конечные точки

Feasibility: adherence to intervention - number of completed sessions [Срок оценки: 2x/week over the 4-week intervention]
Feasibility: presence of adverse or undesirable effects during the intervention [Срок оценки: Post-Intervention (week4)]
Feasibility: Number of participants recruited in each program [Срок оценки: Pre-intervention (week0)]
Feasibility: Characteristics of stroke participants: age [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of stroke participants: sex [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of stroke participants: gender [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of stroke participants: walking capacity [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of stroke participants: cognitive function [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of stroke participants: visual-perceptual function [Срок оценки: Pre-intervention (week 0)]
Feasibility: Characteristics of clinicians [Срок оценки: Pre-intervention (week0)]

Критерии участия

Критерии включения

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).