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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard object battery and training sequence | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Total Time to Complete Activities of Daily Living | Such activities can include navigation, shopping and cooking. | Month 6 |
| Path Length | Total length of the path taken when participants perform navigation task. | Month 6 |
| Success Rate | Percentage of participants who achieve the destination and/or target in the navigation task. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John R Rizzo, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States | ||
| Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36879333 | Derived | 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. |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| VIS4ION System | Device | 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. |
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| 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. |
| 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. | Baseline, Month 6 |
| Salaya |
| Thailand |
| Mahidol University International College | Salaya | Thailand |
| Ratchasuda College, Mahidol University | Salaya | Thailand |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |