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NCT Number: NCT07442461

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VIS4ION Platform

Device

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.

Primary outcomes

  1. Localization Accuracy Percentage

    Time frame: Baseline

    Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.

  2. Orientation Precision Percentage

    Time frame: Baseline

    Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.

  3. Percentage of Tasks Successfully Completed

    Time frame: Baseline

    Phase I only.

  4. Object/Hazard Detection Error Rate

    Time frame: Baseline

    Phase I only. Object/hazard detection error rate measured during navigation tasks.

  5. Average Time to Complete Activities of Daily Living (ADLs)

    Time frame: Baseline

    Phase I only.

  6. Change from Baseline in Moderate-Equivalent Minutes of Physical Activity Per Week

    Time frame: 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).

  7. Change from Baseline in Average Daily Step Count

    Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)

    Phase II only.

  8. Change from Baseline in Blood Pressure

    Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12

    Phase II only.

  9. Change from Baseline in Resting Heart Rate

    Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12

    Phase II only.

  10. Change from Baseline in Body Weight

    Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12

    Phase II only.

Secondary outcomes

  1. System Usability Scale (SUS) Score

    Time frame: 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.

  2. Change in WHO Quality of Life Brief Instrument (WHO-QoL-BREF) Score

    Time frame: 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.

  3. Change in National Eye Institute Visual Function Questionnaire (VFQ-25) Score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giles Hamilton-Fletcher

CONTACT

[email protected]

646-906-6008

Mahya Beheshti

CONTACT

[email protected]

646-501-9189

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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