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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Visual Impairment
• Intervention / Treatment: Device: VIS4ION Platform

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahya Beheshti; Phone Number: 646-501-9189; Email: Mahya.beheshti@nyulangone.org
• Study Contact Backup: Name: Giles Hamilton-Fletcher; Phone Number: 646-906-6008; Email: Giles.hamilton-fletcher@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: VIS4ION 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.
Experimental: 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.	Device: VIS4ION 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.
Experimental: 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.	Device: VIS4ION 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization Accuracy Percentage	Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.	Baseline
Orientation Precision Percentage	Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.	Baseline
Percentage of Tasks Successfully Completed	Phase I only.	Baseline
Object/Hazard Detection Error Rate	Phase I only. Object/hazard detection error rate measured during navigation tasks.	Baseline
Average Time to Complete Activities of Daily Living (ADLs)	Phase I only.	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).	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.	Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Blood Pressure	Phase II only.	Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Resting Heart Rate	Phase II only.	Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Body Weight	Phase II only.	Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: John-Ross Rizzo, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vision Disorders
• Other Study ID Numbers: 25-00717; R01EY037505 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Mahya.beheshti@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Mahya.beheshti@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No