Visual Impairment
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVIS4ION 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.
Sponsors
NYU Langone Health
National Eye Institute (NEI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localization Accuracy Percentage | Baseline | Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter. |
| Orientation Precision Percentage | Baseline | Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees. |
| Percentage of Tasks Successfully Completed | Baseline | Phase I only. |
| Object/Hazard Detection Error Rate | Baseline | Phase I only. Object/hazard detection error rate measured during navigation tasks. |
| Average Time to Complete Activities of Daily Living (ADLs) | Baseline | Phase I only. |
| Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week | 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 | Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B) | Phase II only. |
| Change from Baseline in Blood Pressure | Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12 | Phase II only. |
| Change from Baseline in Resting Heart Rate | Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12 | Phase II only. |
| Change from Baseline in Body Weight | Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12 | Phase II only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) Score | End of Intervention Period (Month 6 for Group A; Month 12 for Group B) | 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 | Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B) | 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 | Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B) | 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. |
Countries
United States
Contacts
CONTACTMahya Beheshti
CONTACTGiles Hamilton-Fletcher
PRINCIPAL_INVESTIGATORJohn-Ross Rizzo, MD
NYU Langone Health
Outcome results
None listed