Virtual Assistance for Daily Living: Neurophysiological and Functional Effects in Low Vision

Официальное название

Effects of Visual Impairment on Neurophysiological Responses and the Feasibility and Impact of Multimodal Virtual Assistance for Instrumental Activities of Daily Living in Low Vision Populations

Обзор

This study aims to investigate how visual impairment affects neurophysiological and biomechanical responses during real-world navigation and daily activities, with a focus on the rehabilitative feasibility and impact of assistive technologies. These technologies include applications and wearable devices designed to support various aspects of daily living for individuals with visual impairment. The VIS4ION platform (Visually Impaired Smart Service System for Spatial Intelligence \& On-board Navigation), a wearable system providing tactile and auditory feedback, is one component of this broader study. VIS4ION is designed to enhance environmental awareness and reduce cognitive load during mobility tasks for the visually impaired.

Подробное описание

Participants with low vision and matched controls will complete walking, navigation, information gathering, and object identification / reaching tasks in both controlled laboratory and real-world environments. Throughout these tasks, physiological measures (e.g., electrodermal activity, heart rate, brain activity, eye movements), biomechanical data (e.g., gait, posture, limb movements), and cognitive metrics will be collected. VIS4ION will be specifically evaluated for its potential to improve the low vision users' scene understanding, navigation efficiency, increase physical activity (e.g., step count, moderate-equivalent minutes), and contribute to improved outcomes in terms of health, awareness, cognitive load, and safety.

Study tasks include obstacle negotiation, dual-task walking, and object identification / reaching under varying conditions (indoor vs. outdoor; with vs. without VIS4ION). A subset of participants will use VIS4ION over extended periods to assess its impact on activities in daily life in real-world settings.

Вмешательства

• Устройство VIS4ION Platform
  The VIS4ION platform, a non-invasive wearable and smartphone-based system providing auditory (bone-conduction headphones) and haptic (wristband/belt) feedback to enhance mobility and daily living for people with blindness or low vision.

Первичные конечные точки

• Localization Accuracy Percentage [Срок оценки: Baseline]
• Orientation Precision Percentage [Срок оценки: Baseline]
• Percentage of Tasks Successfully Completed [Срок оценки: Baseline]
• Object/Hazard Detection Error Rate [Срок оценки: Baseline]
• Average Time to Complete Activities of Daily Living (ADLs) [Срок оценки: Baseline]
• Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week [Срок оценки: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)]
• Change from Baseline in Average Daily Step Count [Срок оценки: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)]
• Change from Baseline in Blood Pressure [Срок оценки: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12]
• Change from Baseline in Resting Heart Rate [Срок оценки: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12]
• Change from Baseline in Body Weight [Срок оценки: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12]

Вторичные конечные точки (3)

• System Usability Scale (SUS) Score [Срок оценки: End of Intervention Period (Month 6 for Group A; Month 12 for Group B)]
• Change in WHO Quality of Life Brief Instrument (WHO-QoL-BREF) Score [Срок оценки: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)]
• Change in National Eye Institute Visual Function Questionnaire (VFQ-25) Score [Срок оценки: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)]

Критерии участия

Критерии включения

People with Visual Impairment:

• Age between 18 and 80 years.
• Diagnosis of visual impairment (any level, any etiology).
• Current use of a primary mobility assistive device (e.g., white cane or guide dog).
• Ability to travel independently (without assistance from another person).
• Capacity to provide informed consent.
• Willingness to complete all study-related assessments and procedures

Healthy Controls:

• Age between 18 and 80 years.
• No self-reported visual impairment or use of mobility assistive devices.
• Capacity to provide informed consent.
• Willingness to complete all study-related assessments and procedures.

Критерии исключения

• Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
• Previous neurological illness, complicated medical condition (inclusive of comorbid cognitive impairment)
• Significant mobility restrictions; people using walkers and wheelchairs
• Pregnancy
• Profound auditory impairments (i.e., cannot understand human speech)
• Somatosensory impairments to the trunk or torso that precludes use of the haptic interfaces
• Significant depression (score > 11 on the Geriatric Depression scale)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07442461 · 25-00717 · R01EY037505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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