Feasibility of Real-Time Visual Feedback in Augmented Reality to Reduce Gait Asymmetry Post-Stroke

Official title

Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality Environment to Reduce Spatial Gait Asymmetry in Adults Post-Stroke

Overview

Unilateral motor deficits, such as paresis and tone disorders, are frequent consequences of stroke and lead to gait impairments. Among these, spatial asymmetry is characterized by differences in step length between the paretic and non-paretic limbs, resulting in balance problems and an increased risk of falls. Conventional rehabilitation has shown limited effectiveness in addressing this issue, highlighting the need for innovative approaches. Real-time feedback interventions, particularly through augmented reality (AR), may help improve gait asymmetry by providing a more natural and interactive learning environment. This study aims to compare the effectiveness of two types of real-time visual feedback, an avatar-based system and visual bars, in improving gait symmetry and other locomotor parameters in individuals post-stroke. It will also assess the acceptability and usability of the intervention, participants' sense of presence, and the potential for cybersickness induced by these systems. A repeated-measures design will be used to evaluate the immediate effectiveness of the two types of visual feedback on gait asymmetry and other locomotor parameters in adults in the subacute phase after stroke. Participants, aged 18 to 65 and presenting spatial asymmetry, will perform walking trials in an AR environment while being exposed to both feedback modalities in randomized order. Spatiotemporal and kinematic data will be collected using inertial sensors, while questionnaires will assess acceptability, usability, sense of presence, and cybersickness. Participants will be evaluated in a 45-m long corridor (free of traffic) and will perform nine walking trials (three per condition) under three randomized conditions: (1) a lateral view avatar displayed on the paretic side, previously shown to provide optimal feedback on step length; (2) a visual bar feedback representing bilateral step lengths; and (3) a "control" condition with no additional feedback. Each walking trial, lasting 2.5 minutes, will consist of a pre-adaptation phase without feedback (30 s), followed by an adaptation phase with feedback (1 min), and a post-adaptation phase without feedback (1 min). The investigators expect that avatar-based feedback will be more effective than visual bars in improving spatial symmetry. The investigators also anticipate that both feedback modalities will be well accepted and usable by participants without inducing cybersickness, but that the sense of presence will be higher with avatar-based feedback. This study will shed light on locomotor adjustment mechanisms and may lay the groundwork for future clinical trials. By offering a personalized, evidence-based approach, these results could help transform post-stroke rehabilitation through the integration of innovative tools to optimize functional recovery.

Interventions

• Device Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality
  Participants will walk in a corridor (45 m), equipped with "Xsens" inertial sensors recording their kinematics and an "HTC Vive Elite-XR" AR headset superimposing virtual feedback onto the real world. Three real-time feedback conditions (3 trials/condition) will be evaluated randomly: (1) an avatar reflecting the participant's movements; (2) visual bars indicating step lengths; (3) control condition without feedback. Participants take part in an evaluation/intervention session.

Primary outcome measures

• Step length ratio [Time frame: For each condition the step length ratio will be assessed at each trial: before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]

Secondary outcome measures (11)

• Walking speed [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Step width [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Gait cycle duration percentages [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Trunk and pelvis maximum range of motion [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Hip and knee range of motion [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Ankle range of motion [Time frame: For each condition : before the pre-adaptation phase (T1: 0 s), after the pre-adaptation phase (T2: 0.5 min), after the adaptation phase (T3: 1.5 min), and after the post-adaptation phase (T4: 2.5 min).]
• Acceptability [Time frame: Investigators will compare these parameters before et after the session.]
• Usability [Time frame: Investigators will compare these parameters before and after the intervention.]
• Embodiment [Time frame: Investigators will compare these parameters before et after the intervention.]
• Sens of Presence [Time frame: Investigators will compare these parameters before et after the session.]
• Cybersickness [Time frame: Investigators will compare these parameters before et after the session]

Eligibility criteria

Inclusion criteria

• All participants must be in the subacute phase, between 14 days and 6 months following a first supratentorial stroke
• able to walk with or without an assistive device for at least 2.5 minutes
• present spatial asymmetry (step length ratio, SLR > 1.08)

Exclusion criteria

• Abnormal or no-corrected visual acuity (EDTRS < 50/20)
• visual field deficits (Goldmann or computerized perimetry)
• cognitive impairment (Montreal Cognitive Assessment score < 22
• not being able to provide informed consent
• present other conditions besides stroke that limit walking.

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

Treatment

Study locations

Canada · 1 center

• Jewish Rehabilitation Hospital - CISSS Laval — Laval

Identifiers

NCT: NCT07178535 · MP-50-2025-2284 · 2025-2026 - BF7 - 363369

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗