SmartHMD for Improved Mobility

NCT03781583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-12-12

Study results available
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Summary

The National Eye Institute estimated about 3 million people over age 40 in the US had low vision in 2010 and projects an increase to nearly 5 million in 2030 and 9 million in 2050. Current assistive technologies are a patchwork of mostly low-technology aids with limited capabilities that are often difficult to use, and are not widely adopted. This shortfall in capabilities of assistive technology often stems from lack of a user-centered design approach and is a critical barrier to improve the everyday activities of life (EDAL) and the quality of life (QOL) for individuals with low vision.

An intuitive head mounted display (HMD) system on enhancing orientation and mobility (O\&M) and crosswalk navigation, could improve independence, potentially decrease falls, and improve EDAL and QOL. The central hypothesis is that an electronic navigation system incorporating computer vision will enhance O\&M for individuals with low vision. The goal is to develop and validate a smartHMD by incorporating advanced computer vision algorithms and flexible user interfaces that can be precisely tailored to an individual's O\&M need. This project will address the specific question of mobility while the subject crosses a street at a signaled crosswalk. This is a dangerous and difficult task for visually impaired patients and a significant barrier to independent mobility.

Conditions

  • Low Vision
  • Orientation
  • Mobility Limitation
  • Navigation, Spatial
  • Visual Impairment

Interventions

DEVICE

SmartHMD version 1

First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds.

DEVICE

SmartHMD version 2

Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones.

DEVICE

SmartHMD version 3

Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software.

DEVICE

SmartHMD version 4

Fourth iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and a specific version of custom software.

Sponsors & Collaborators

  • James Weiland

    lead OTHER

Principal Investigators

  • James Weiland, PhD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-26
Primary Completion
2022-11-07
Completion
2022-11-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781583 on ClinicalTrials.gov