Clinical trial NCT03174314: Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices
Official title: Feasibility and Efficacy of the VIS4ION Platform and Assistive Tactile and Auditory Communicating Devices in Low Vision Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Keywords: Visual Impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Correct Responses by Feedback Devices
timeFrame: Month 6
measure: Total Time to Complete Activities of Daily Living
timeFrame: Month 6
measure: Path Length
timeFrame: Month 6
measure: Success Rate
timeFrame: Month 6
Secondary outcomes:
measure: Change in International Physical Activity Questionnaire (IPAQ) Score
timeFrame: Baseline, Month 6
measure: Change in World Health Organization Quality of Life (WHOQOL)-BREF Score
timeFrame: Baseline, Month 6
measure: Change in Visual Functioning Questionnaire - 25 (VFQ-25) Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Salaya
country: Thailand
facility: Mahidol University College of Music, Engineering, Science, Religious Studies, Social Sciences and Humanities
city: Salaya
country: Thailand
facility: Mahidol University International College
city: Salaya
country: Thailand
facility: Ratchasuda College, Mahidol University
Study officials:
affiliation: NYU Langone Health
name: John R Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
References: