About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
VIS4ION Platform
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Localization Accuracy Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Orientation Precision Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Percentage of Tasks Successfully Completed
Phase I only.
Object/Hazard Detection Error Rate
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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NYU Langone Health
Lead sponsor
National Eye Institute (NEI)
Collaborator
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