Virtual Reality for Post-Stroke Gait Rehabilitation

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

• Subjects with comorbidities interfering with walking
• Subjects with comorbidities interfering with visual perception
• Subjects without medical clearance for exercise

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Canada · 1 center

• Jewish Rehabilitation Hospital — Laval

Identifiers

NCT: NCT07201974 · MP-50-2026-2380

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗