Visual ImpairmentVIS4IONNCT03174314
Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices
A study testing Standard object battery and training sequence and VIS4ION System in people with Visual Impairment, run by NYU Langone Health at 4 sites in 2 countries.
Trial summary
This pilot study will integrate multi-sensor fusion techniques (software) to effectively combine information obtained from the newly embedded infrared, ultrasound, and stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform. 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?
- Standard object battery and training sequence and VIS4ION System
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Jul 2017to 23 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 impairments of all different levels and etiologies.
Who cannot join
- Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
- Previous neurological illness, complicated medical condition;
- Significant mobility restrictions; people using walkers and wheelchairs
- Pregnancy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Thailand3 sites
Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities
Salaya
Mahidol University International College
Salaya
Ratchasuda College, Mahidol University
Salaya
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Feasibility and Efficacy of the VIS4ION Platform and Assistive Tactile and Auditory Communicating Devices in Low Vision Subjects
This pilot study will integrate multi-sensor fusion techniques (software) to effectively combine information obtained from the newly embedded infrared, ultrasound, and stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform.
The core of this technology is based on 4 components: (1) a wearable vest with several distinct range and image sensors embedded. These sensors extract pertinent information about obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that communicates this spatial information to the end-user in real-time via an intuitive, ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or 4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers (leaving the ear canal patent for ambient sounds) and a microphone for oral communication-based voice recognition during use of a virtual personal assistant (VPA).
Read more
Blindfolded-sighted, and blind subjects in a real-world, combined obstacle avoidance / navigation task will serve as an independent measure of overall improvements in the system as well as a roadmap for future avenues to enhance performance.
Further, a prospective, randomized crossover, controlled, non-blinded phase will be conducted in Thailand as part of this study to compare and evaluate effectiveness of the wearable vest for increasing navigation and quality of life.
Read the detailed description
Investigators will try to develop algorithms that will recognize multiple objects and persons in real-time (enhanced scene interpretation for multi-object identification). And based on that, human-centered simulation trials and experiments for feasibility and efficacy of the platform's tactile and auditory 'communication' outputs will be conducted. Finally auditory and tactile 'prompts' (system output) based on the end user's immediate needs based on initial testing results, will be integrated into the platform.
Additional activities will occur at the Thailand site. In the second phase, an improved system will be tested in an extended-use experiment, detecting for health-related changes in our participants (increased mobility and QoL). The study team will further test the generalizability of the new mapping technology in a more challenging environment, testing system performance using metrics, comparing results between current and previous systems.
- Conditions
- Visual Impairment
- Being tested
- Standard object battery and training sequence, VIS4ION System
- Keywords
- Visual Impairment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard object battery and training sequenceBehavioural
Used to examine human localization and identification performance. Object battery will include: trip hazards ('pucks' with various height/width combinations to represent children's toys, street debris, rocks, pets, etc.), furniture (chairs, desks, couches, benches), people, walls, and corridors. Objects will be recorded by placing them to the right or left on the path-of-travel. Raw sensor outputs for single obstacles and walls in isolation (trip-hazard pucks with 8 heights, chair, desk, person, wall) and the same set of single obstacles against a wall. This set of 23 raw sensor traces can be used in various combinations (e.g., encountering a curb and then a person, or a chair) to create a training sequence that will help experimentally naïve subjects to understand the correspondence between tactile stimulation and the real-world scenario it is intended to depict.
VIS4ION SystemDevice
When in "Assistive Mode," participants will navigate campus while receiving navigation assistance (acquiring data and simultaneously providing assistance/audio feedback). When in "Passive Mode," participants will navigate campus wearing the backpack without receiving navigation assistant.
| Study group | Role | What they receive |
|---|---|---|
| Visually impaired | Experimental | Visually impaired subjects will provide continuity across iterations of the testing, allowing for direct comparisons of responses within an individual for a single behavioral measure across different iterations of the device architecture and output configuration. Receives: Behavioral: Standard object battery and training sequence |
| Healthy controls | Active comparator | Healthy (naive) subjects invaluable insights as well as a range of body types, cognitive abilities, and other idiosyncrasies that will keep our design and testing process from tailoring the device to a small set of individuals rather than the broader population. Receives: Behavioral: Standard object battery and training sequence |
| Thailand Site - Group A: Assistive Mode then Passive Mode | Experimental | During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days Receives: Device: VIS4ION System |
| Thailand Site - Group B: Passive Mode then Assistive Mode | Active comparator | Group B will go through a passive mode for the first 15 days and then an assistive mode for the second half of the month Receives: Device: VIS4ION System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Correct Responses by Feedback Devices
Assessment of ability of the feedback devices (vibrating belt- wrist band/haptic interface and audio output/open-ear headset) to provide correct responses on alternative force choice tasks during simulation experiments.
Measured: Month 6
Total Time to Complete Activities of Daily Living
Such activities can include navigation, shopping and cooking.
Measured: Month 6
Path Length
Total length of the path taken when participants perform navigation task.
Measured: Month 6
Success Rate
Percentage of participants who achieve the destination and/or target in the navigation task.
Measured: Month 6
Secondary outcomes (3)
Change in International Physical Activity Questionnaire (IPAQ) Score
7-item questionnaire assessing the types and intensity of physical activity and sitting time that people do as part of their daily lives; the total score is total physical activity, which is quantified in metabolic equivalent (MET) minutes per week.
Measured: Baseline, Month 6
Change in World Health Organization Quality of Life (WHOQOL)-BREF Score
WHOQOL-BREF is a 26-item questionnaire assessing how patients have felt about their quality of life and health over the past 4 weeks. Each item is rated on a scale from 1-5. The raw score is the sum of responses and is rescaled to a total score of 0-100; higher scores indicate greater health states.
Measured: Baseline, Month 6
Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score
25-item assessment of how participants feel about their vision or vision condition. Each item is rated on a scale from 1-6. The raw score is the sum of responses and is converted to a 0-100 scale for the total score; higher scores indicate greater visual functioning.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start26 Jul 2017
- Primary completion2 Jun 2023
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John R Rizzo, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174314
- Sponsor's protocol ID
- 17-00317
- Acronym
- VIS4ION
- Status last verified
- May 2025
- First submitted
- 30 May 2017
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beheshti M, Naeimi T, Hudson TE, Feng C, Mongkolwat P, Riewpaiboon W, Seiple W, Vedanthan R, Rizzo JR. A Smart Service System for Spatial Intelligence and Onboard Navigation for Individuals with Visual Impairment (VIS4ION Thailand): study protocol of a randomized controlled trial of visually impaired students at the Ratchasuda College, Thailand. Trials. 2023 Mar 7;24(1):169. doi: 10.1186/s13063-023-07173-8.
PubMed 36879333
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Efficacy of the VIS4ION Platform and Assistive Tactile and Auditory Communicating Devices in Low Vision Subjects
- ClinicalTrials.gov ID
- NCT03174314
- Acronym / sponsor ID
- VIS4ION / 17-00317
- Conditions
- Visual Impairment
- Keywords
- Visual Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 2 Jun 2017 (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 pilot study will integrate multi-sensor fusion techniques (software) to effectively combine information obtained from the newly embedded infrared, ultrasound, and stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform.
The core of this technology is based on 4 components: (1) a wearable vest with several distinct range and image sensors embedded. These sensors extract pertinent information about obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that communicates this spatial information to the end-user in real-time via an intuitive, ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or 4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers (leaving the ear canal patent for ambient sounds) and a microphone for oral communication-based voice recognition during use of a virtual personal assistant (VPA).
Blindfolded-sighted, and blind subjects in a real-world, combined obstacle avoidance / navigation task will serve as an independent measure of overall improvements in the system as well as a roadmap for future avenues to enhance performance.
Further, a prospective, randomized crossover, controlled, non-blinded phase will be conducted in Thailand as part of this study to compare and evaluate effectiveness of the wearable vest for increasing navigation and quality of life.
Detailed description
Investigators will try to develop algorithms that will recognize multiple objects and persons in real-time (enhanced scene interpretation for multi-object identification). And based on that, human-centered simulation trials and experiments for feasibility and efficacy of the platform's tactile and auditory 'communication' outputs will be conducted. Finally auditory and tactile 'prompts' (system output) based on the end user's immediate needs based on initial testing results, will be integrated into the platform.
Additional activities will occur at the Thailand site. In the second phase, an improved system will be tested in an extended-use experiment, detecting for health-related changes in our participants (increased mobility and QoL). The study team will further test the generalizability of the new mapping technology in a more challenging environment, testing system performance using metrics, comparing results between current and previous systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Visually impaired | Experimental | Behavioral: Standard object battery and training sequenceVisually impaired subjects will provide continuity across iterations of the testing, allowing for direct comparisons of responses within an individual for a single behavioral measure across different iterations of the device architecture and output configuration. |
| Healthy controls | Active comparator | Behavioral: Standard object battery and training sequenceHealthy (naive) subjects invaluable insights as well as a range of body types, cognitive abilities, and other idiosyncrasies that will keep our design and testing process from tailoring the device to a small set of individuals rather than the broader population. |
| Thailand Site - Group A: Assistive Mode then Passive Mode | Experimental | Device: VIS4ION SystemDuring the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days |
| Thailand Site - Group B: Passive Mode then Assistive Mode | Active comparator | Device: VIS4ION SystemGroup B will go through a passive mode for the first 15 days and then an assistive mode for the second half of the month |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- People with visual impairments of all different levels and etiologies.
Key exclusion criteria (4 listed)
- Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)
- Previous neurological illness, complicated medical condition;
- Significant mobility restrictions; people using walkers and wheelchairs
- Pregnancy
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 |
|---|---|---|
| Standard object battery and training sequenceUsed to examine human localization and identification performance. Object battery will include: trip hazards ('pucks' with various height/width combinations to represent children's toys, street debris, rocks, pets, etc.), furniture (chairs, desks, couches, benches), people, walls, and corridors. Objects will be recorded by placing them to the right or left on the path-of-travel. Raw sensor outputs for single obstacles and walls in isolation (trip-hazard pucks with 8 heights, chair, desk, person, wall) and the same set of single obstacles against a wall. This set of 23 raw sensor traces can be used in various combinations (e.g., encountering a curb and then a person, or a chair) to create a training sequence that will help experimentally naïve subjects to understand the correspondence between tactile stimulation and the real-world scenario it is intended to depict. | Behavioural | Healthy controls, Visually impaired |
| VIS4ION SystemWhen in "Assistive Mode," participants will navigate campus while receiving navigation assistance (acquiring data and simultaneously providing assistance/audio feedback). When in "Passive Mode," participants will navigate campus wearing the backpack without receiving navigation assistant. | Device | Thailand Site - Group A: Assistive Mode then Passive Mode, Thailand Site - Group B: Passive Mode then Assistive Mode |
Primary outcome
Percentage of Correct Responses by Feedback Devices
Time frame: Month 6
Assessment of ability of the feedback devices (vibrating belt- wrist band/haptic interface and audio output/open-ear headset) to provide correct responses on alternative force choice tasks during simulation experiments.
Total Time to Complete Activities of Daily Living
Time frame: Month 6
Such activities can include navigation, shopping and cooking.
Path Length
Time frame: Month 6
Total length of the path taken when participants perform navigation task.
Success Rate
Time frame: Month 6
Percentage of participants who achieve the destination and/or target in the navigation task.
3 secondary outcomes
Change in International Physical Activity Questionnaire (IPAQ) Score
Time frame: Baseline, Month 6
Change in World Health Organization Quality of Life (WHOQOL)-BREF Score
Time frame: Baseline, Month 6
Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score
Time frame: Baseline, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 36879333Beheshti M, Naeimi T, Hudson TE, Feng C, Mongkolwat P, Riewpaiboon W, Seiple W, Vedanthan R, Rizzo JR. A Smart Service System for Spatial Intelligence and Onboard Navigation for Individuals with Visual Impairment (VIS4ION Thailand): study protocol of a randomized controlled trial of visually impaired students at the Ratchasuda College, Thailand. Trials. 2023 Mar 7;24(1):169. doi: 10.1186/s13063-023-07173-8.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
John R Rizzo, MD principal investigator
NYU Langone Health
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard object battery and training sequence and VIS4ION System in people with Visual Impairment, run by NYU Langone Health at 4 sites in 2 countries.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Correct Responses by Feedback Devices (time frame: Month 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03174314, which also lists 1 linked publication.
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 30 May 2025.