Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

Not Applicable

Active, not recruiting

• Conditions: Visual Impairment
• Interventions: Behavioral: Standard object battery and training sequence; Device: VIS4ION System

• Registration Number: NCT03174314
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-02
• Study Start: 2017-07-26
• Primary Completion: 2023-06-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of Correct Responses by Feedback Devices	Month 6	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	Month 6	Such activities can include navigation, shopping and cooking.
Path Length	Month 6	Total length of the path taken when participants perform navigation task.
Success Rate	Month 6	Percentage of participants who achieve the destination and/or target in the navigation task.

Secondary Outcome Measures

Name	Time	Method
Change in International Physical Activity Questionnaire (IPAQ) Score	Baseline, Month 6	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	Baseline, Month 6	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	Baseline, Month 6	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.

Trial Locations

Locations (4)

New York University School of Medicine; 🇺🇸 New York, New York, United States

Ratchasuda College, Mahidol University; 🇹🇭 Salaya, Thailand

Mahidol University International College; 🇹🇭 Salaya, Thailand

Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities; 🇹🇭 Salaya, Thailand