Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

Visual Impairment Clinical Trial

— VIS4ION  

Official title:

Feasibility and Efficacy of the VIS4ION Platform and Assistive Tactile and Auditory Communicating Devices in Low Vision Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03174314
• Other study ID #: 17-00317
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 26, 2017
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2025
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Behavioral:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Thailand	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
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Countries where clinical trial is conducted

United States,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total Time to Complete Activities of Daily Living	Such activities can include navigation, shopping and cooking.	Month 6
Primary	Path Length	Total length of the path taken when participants perform navigation task.	Month 6
Primary	Success Rate	Percentage of participants who achieve the destination and/or target in the navigation task.	Month 6
Secondary	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
Secondary	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
Secondary	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