Visual ImpairmentNCT07442461
Virtual Assistance for Daily Living: Neurophysiological and Functional Effects in Low Vision
A study testing VIS4ION Platform in people with Visual Impairment, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- What is being tested?
- VIS4ION Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Visual Impairment
- Being tested
- VIS4ION Platform
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIS4ION PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Technical Evaluation Group | Experimental | 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. Receives: Device: VIS4ION Platform |
| Extended Use Trial: Group A | Experimental | 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. Receives: Device: VIS4ION Platform |
| Extended Use Trial: Group B | Experimental | 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. Receives: Device: VIS4ION Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Localization Accuracy Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Measured: Baseline
Orientation Precision Percentage
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Measured: Baseline
Percentage of Tasks Successfully Completed
Phase I only.
Measured: Baseline
Object/Hazard Detection Error Rate
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Measured: Baseline
Average Time to Complete Activities of Daily Living (ADLs)
Phase I only.
Measured: 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).
Measured: 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.
Measured: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Change from Baseline in Blood Pressure
Phase II only.
Measured: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Resting Heart Rate
Phase II only.
Measured: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Change from Baseline in Body Weight
Phase II only.
Measured: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- John-Ross Rizzo, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442461
- Sponsor's protocol ID
- 25-00717
- Other IDs
- R01EY037505
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07442461
- Acronym / sponsor ID
- 25-00717
- Conditions
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Technical Evaluation Group | Experimental | Device: VIS4ION PlatformParticipants, 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 | Experimental | Device: VIS4ION PlatformParticipants 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 | Experimental | Device: VIS4ION PlatformParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIS4ION PlatformThe 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. | Device | Extended Use Trial: Group A, Extended Use Trial: Group B, Technical Evaluation Group |
Primary outcome
Localization Accuracy Percentage
Time frame: Baseline
Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.
Orientation Precision Percentage
Time frame: Baseline
Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.
Percentage of Tasks Successfully Completed
Time frame: Baseline
Phase I only.
Object/Hazard Detection Error Rate
Time frame: Baseline
Phase I only. Object/hazard detection error rate measured during navigation tasks.
Average Time to Complete Activities of Daily Living (ADLs)
Time frame: Baseline
Phase I only.
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).
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.
Change from Baseline in Blood Pressure
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
Change from Baseline in Resting Heart Rate
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
Change from Baseline in Body Weight
Time frame: Baseline, Month 3; Baseline, Month 6; Baseline, Month 9; Baseline, Month 12
Phase II only.
3 secondary outcomes
System Usability Scale (SUS) Score
Time frame: 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
Time frame: 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
Time frame: Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John-Ross Rizzo, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIS4ION Platform in people with Visual Impairment, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahya Beheshti (646-501-9189, Mahya.beheshti@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Localization Accuracy Percentage (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.