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Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices (VIS4ION)

Primary Purpose

Visual Impairment

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Standard object battery and training sequence
VIS4ION System
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Impairment focused on measuring Visual Impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York University School of Medicine
  • Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities
  • Mahidol University International College
  • Ratchasuda College, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Visually impaired

Healthy controls

Thailand Site - Group A: Assistive Mode then Passive Mode

Thailand Site - Group B: Passive Mode then Assistive Mode

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.
Total Time to Complete Activities of Daily Living
Such activities can include navigation, shopping and cooking.
Path Length
Total length of the path taken when participants perform navigation task.
Success Rate
Percentage of participants who achieve the destination and/or target in the navigation task.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 30, 2017
Last Updated
September 18, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03174314
Brief Title
Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices
Acronym
VIS4ION
Official Title
Feasibility and Efficacy of the VIS4ION Platform and Assistive Tactile and Auditory Communicating Devices in Low Vision Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
June 2, 2023 (Actual)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment
Keywords
Visual Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visually impaired
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Thailand Site - Group A: Assistive Mode then Passive Mode
Arm Type
Experimental
Arm Description
During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days
Arm Title
Thailand Site - Group B: Passive Mode then Assistive Mode
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard object battery and training sequence
Intervention Description
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
Device
Intervention Name(s)
VIS4ION System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Correct Responses by Feedback Devices
Description
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.
Time Frame
Month 6
Title
Total Time to Complete Activities of Daily Living
Description
Such activities can include navigation, shopping and cooking.
Time Frame
Month 6
Title
Path Length
Description
Total length of the path taken when participants perform navigation task.
Time Frame
Month 6
Title
Success Rate
Description
Percentage of participants who achieve the destination and/or target in the navigation task.
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Change in International Physical Activity Questionnaire (IPAQ) Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in World Health Organization Quality of Life (WHOQOL)-BREF Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score
Description
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.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Rizzo, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities
City
Salaya
Country
Thailand
Facility Name
Mahidol University International College
City
Salaya
Country
Thailand
Facility Name
Ratchasuda College, Mahidol University
City
Salaya
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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