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

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NYU Langone Health

Status

Completed

Conditions

Visual Impairment

Treatments

Device: VIS4ION System
Behavioral: Standard object battery and training sequence

Study type

Interventional

Funder types

Other

Identifiers

NCT03174314
17-00317

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 4 patient groups

Visually impaired
Experimental group
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.
Treatment:
Behavioral: Standard object battery and training sequence
Healthy controls
Active Comparator group
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.
Treatment:
Behavioral: Standard object battery and training sequence
Thailand Site - Group A: Assistive Mode then Passive Mode
Experimental group
Description:
During the first 15 days, group A will go through an assistive mode and then a passive mode for the next 15 days
Treatment:
Device: VIS4ION System
Thailand Site - Group B: Passive Mode then Assistive Mode
Active Comparator group
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
Treatment:
Device: VIS4ION System

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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