Virtual Assistance for Daily Living: Neurophysiological and Functional Effects in Low Vision

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNYU Langone Health

About this trial

This study aims to investigate how visual impairment affects neurophysiological and biomechanical responses during real-world navigation and daily activities, with a focus on the rehabilitative feasibility and impact of assistive technologies. These technologies include applications and wearable devices designed to support various aspects of daily living for individuals with visual impairment. The VIS4ION platform (Visually Impaired Smart Service System for Spatial Intelligence \& On-board Navigation), a wearable system providing tactile and auditory feedback, is one component of this broader study. VIS4ION is designed to enhance environmental awareness and reduce cognitive load during mobility tasks for the visually impaired.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age between 18 and 80 years.

Diagnosis of visual impairment (any level, any etiology).

Current use of a primary mobility assistive device (e.g., white cane or guide dog).

Ability to travel independently (without assistance from another person).

Disqualifiers

Significant cognitive dysfunction (score <24 on Folsteins' Mini Mental Status Examination)

Previous neurological illness, complicated medical condition (inclusive of comorbid cognitive impairment)

Significant mobility restrictions; people using walkers and wheelchairs

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • VIS4ION Platform

    Device

    The VIS4ION platform, a non-invasive wearable and smartphone-based system providing auditory (bone-conduction headphones) and haptic (wristband/belt) feedback to enhance mobility and daily living for people with blindness or low vision.

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: Technical Evaluation GroupExperimental treatment 1 intervention
Group B: Extended Use Trial: Group AExperimental treatment 1 intervention
Group C: Extended Use Trial: Group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Localization Accuracy Percentage

Phase I only. Successful location accuracy defined as percentage of attempts with localization accuracy within 1 meter.

Time frame
Baseline
2

Orientation Precision Percentage

Phase I only. Successful location accuracy defined as percentage of attempts with orientation precision within 5 degrees.

Time frame
Baseline
3

Percentage of Tasks Successfully Completed

Phase I only.

Time frame
Baseline
4

Object/Hazard Detection Error Rate

Phase I only. Object/hazard detection error rate measured during navigation tasks.

Time frame
Baseline

Secondary outcomes

1

System Usability Scale (SUS) Score

Phase II only. 10-item assessment evaluating usability of a system. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a standardized score from 0-100; higher scores indicate greater satisfaction.

Time frame
End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
2

Change in WHO Quality of Life Brief Instrument (WHO-QoL-BREF) Score

Phase II only. WHO-QoL-BREF is a 26-item questionnaire assessing quality of life. Each item is rated on a 5-point Likert scale to determine a raw item score. The mean score for each six domains of the questionnaire is calculated, resulting in a mean score per domain that is between 4 and 20. This mean domain score is then multiplied by 4 in order to transform the domain score into a scaled score ranging from 16-80, with a higher score indicating a higher QOL.

Time frame
Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)
3

Change in National Eye Institute Visual Function Questionnaire (VFQ-25) Score

Phase II only. The VFQ-25 is a 25-item assessment of visual function. Each item is rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-100; higher scores indicate greater vision function and vision quality of life.

Time frame
Baseline, End of Intervention Period (Month 6 for Group A; Month 12 for Group B)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Eye Institute (NEI)

Collaborator

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