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
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
March 2, 2026
February 1, 2026
2.8 years
February 25, 2026
February 25, 2026
Conditions
Outcome Measures
Primary Outcomes (10)
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 Outcomes (3)
System Usability Scale (SUS) Score
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
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
Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Study Arms (3)
Technical Evaluation Group
EXPERIMENTALParticipants, 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.
Extended Use Trial: Group A
EXPERIMENTALParticipants 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.
Extended Use Trial: Group B
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John-Ross Rizzo, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 2, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.