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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
150
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.
NYU Langone Health
New York, New York, United States
Localization Accuracy Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Time frame: Baseline
Orientation Precision Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Time frame: Baseline
Percentage of Tasks Successfully Completed
Phase I only.
Time frame: Baseline
Object/Hazard Detection Error Rate
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Time frame: Baseline
Average Time to Complete Activities of Daily Living (ADLs)
Phase I only.
Time frame: Baseline
Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week
Phase II only. Data captured via wearable sensors and the International Physical Activity Questionnaire (IPAQ).
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Average Daily Step Count
Phase II only.
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Blood Pressure
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Resting Heart Rate
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Body Weight
Phase II only.
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
System Usability Scale (SUS) Score
Phase II only. 10-item assessment evaluating usability of a system. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a standardized score from 0-100; higher scores indicate greater satisfaction.
Time frame: 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
Phase II only. WHO-QoL-BREF is a 26-item questionnaire assessing quality of life. Each item is rated on a 5-point Likert scale to determine a raw item score. The mean score for each six domains of the questionnaire is calculated, resulting in a mean score per domain that is between 4 and 20. This mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score ranging from 16-80, with a higher score indicating a higher QOL.
Time frame: 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
Phase II only. The VFQ-25 is a 25-item assessment of visual function. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-100; higher scores indicate greater vision function and vision quality of life.
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
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