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临床试验/NCT07178535
NCT07178535尚未招募不适用

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

McGill University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1
主要终点
Step length ratio

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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.

研究组 & 干预措施

Participant

Experimental

干预措施: Feasibility of Two Types of Real-Time Visual Feedback in an Augmented Reality (Device)

结局指标

主要结局

Step length ratio

时间窗: 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).

For the ratio calculation, the mean step length values from the left and right sides will be used, with the larger value placed in the numerator to ensure that all individual ratios are \>1.0. A ratio of 1.0 will indicate perfect symmetry. We will compare the step length ratio (SLR)

次要结局

  • Walking speed(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(Investigators will compare these parameters before et after the session.)
  • Step width(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(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(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(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(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).)
  • Embodiment(Investigators will compare these parameters before et after the intervention.)
  • Usability(Investigators will compare these parameters before and after the intervention.)
  • Sens of Presence(Investigators will compare these parameters before et after the session.)
  • Cybersickness(Investigators will compare these parameters before et after the session)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anouk Lamontagne

Associate Professor

McGill University

研究点 (1)

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