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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of Tasks Successfully Completed
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Technical Evaluation Group
Participants, both sighted-blindfolded and people with blindness or low vision, will complete simple navigation, object-identification, and object-reaching tasks, both with and without VIS4ION's services.
干预措施: VIS4ION Platform (Device)
Extended Use Trial: Group A
Participants with blindness or low vision will complete navigation and object-identification tasks with the device during months 1-6, then without the device during months 6-12.
干预措施: VIS4ION Platform (Device)
Extended Use Trial: Group B
Participants with blindness or low vision will complete navigation and object-identification tasks without the device during months 1-6, then with the device during months 6-12.
干预措施: VIS4ION Platform (Device)
结局指标
主要结局
Percentage of Tasks Successfully Completed
时间窗: Baseline
Phase I only.
Localization Accuracy Percentage
时间窗: Baseline
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Orientation Precision Percentage
时间窗: Baseline
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Object/Hazard Detection Error Rate
时间窗: Baseline
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Average Time to Complete Activities of Daily Living (ADLs)
时间窗: Baseline
Phase I only.
Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week
时间窗: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Phase II only. Data captured via wearable sensors and the International Physical Activity Questionnaire (IPAQ).
Change from Baseline in Average Daily Step Count
时间窗: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Phase II only.
Change from Baseline in Blood Pressure
时间窗: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
Change from Baseline in Resting Heart Rate
时间窗: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
Change from Baseline in Body Weight
时间窗: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
次要结局
- System Usability Scale (SUS) Score(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(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(Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B))