Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

NCT ID: NCT03174314

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2024-07-23

Brief 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.

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.

Conditions

Visual Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Visually impaired

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.

Group Type: EXPERIMENTAL

Standard object battery and training sequence

Intervention Type: 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.

Healthy controls

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.

Group Type: ACTIVE_COMPARATOR

Standard object battery and training sequence

Intervention Type: 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.

Thailand Site - Group A: Assistive Mode then Passive Mode

During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days

Group Type: EXPERIMENTAL

VIS4ION System

Intervention Type: 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.

Thailand Site - Group B: Passive Mode then Assistive Mode

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

Group Type: ACTIVE_COMPARATOR

VIS4ION System

Intervention Type: 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.

Interventions

Standard object battery and training sequence

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.

Intervention Type: BEHAVIORAL

VIS4ION System

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• People with visual impairments of all different levels and etiologies.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Rizzo, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities

Salaya, , Thailand

Mahidol University International College

Salaya, , Thailand

Ratchasuda College, Mahidol University

Salaya, , Thailand

Countries

United States; Thailand

References

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.

Reference Type: DERIVED

PMID: 36879333 (View on PubMed)

Other Identifiers

17-00317

Identifier Type: -

Identifier Source: org_study_id