Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

NCT03174314 | Completed

• 1 other identifier: 17-00317
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 4

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.

Conditions

Visual Impairment

Keywords

Visual Impairment

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (3)

• Change in International Physical Activity Questionnaire (IPAQ) Score

  Baseline, Month 6

• Change in World Health Organization Quality of Life (WHOQOL)-BREF Score

  Baseline, Month 6

• Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score

  Baseline, Month 6

Study Arms (4)

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.

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.

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

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

Device: VIS4ION System

Interventions

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.

Healthy controls; Visually impaired

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.

Thailand Site - Group A: Assistive Mode then Passive Mode; Thailand Site - Group B: Passive Mode then Assistive Mode

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (4)

New York University School of Medicine

New York, New York, 10016, United States

Location

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

Salaya, Thailand

Location

Mahidol University International College

Salaya, Thailand

Location

Ratchasuda College, Mahidol University

Salaya, Thailand

Location

Related Publications (1)

• 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.

  PMID: 36879333 DERIVED

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John R Rizzo, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: July 26, 2017
• Primary Completion: June 2, 2023
• Study Completion: July 23, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1); TH (3)