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Completed

NCT Number: NCT03781583

SmartHMD for Improved Mobility

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.

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Key information

Conditions

Low Vision Behavior Eye Diseases Mobility Limitation Navigation, Spatial Nervous System Diseases Neurologic Manifestations Orientation Orientation, Spatial Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Spatial Behavior Spatial Navigation Vision Disorders Vision, Low Visual Impairment

Age range

14 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Campus Research Complex

Ann Arbor, Michigan, 48105, United States

About this study

This study was originally intended as a single-arm study. Early results and unanticipated events related to component availability made it clear that multiple configurations of the device would be necessary to produce a functional device. Therefore, the study was split into multiple cohorts representing each iteration of the device and testing process, as follows:

As the trial progressed, the participants recruited were consistently unable to perform tasks without smartHMD. This is due to the recruitment of participants with severe vision loss. Due to this finding, data was only acquired when participants used the smartHMD when active instead of collecting data with and without the system being active.

The participants performed a subset of experiments due to time constraints. Some performed only outdoor trials; some performed only indoor trials; others performed both. The outcome measures depend on which experiments were performed.

After the first test involving the initial three participants, the ODG system became unsupported by the company that produced the device. In response, the study team developed a prototype system (RGBD), which was used in the ODG system's place for the remaining tests. The RGBD was initially used indoors with laptop and subsequently outdoors with mobile hardware and new software.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with low vision
  • Self reported difficulty with mobility and finding doors (either indoors or outdoors) and using signalized crosswalks.
  • Ability to cooperate for tests
  • Able to participate in all visits

Exclusion criteria

  • Unable to use head mounted display technology
  • Unstable age-related macular degeneration within the past 3 months
  • Unstable diabetic retinopathy within the past 3 months
  • Unstable diabetes within the past 3 months
  • Ocular infection or ocular inflammation in the past 3 months
  • Ocular trauma within the past 6 months
  • Intraocular surgery within 6 months
  • Optical coherence tomography retinal findings of concern to investigator for unstable vision during the study
  • Women who are pregnant (due to risk of falls and change in gait).
  • Uncontrolled seizure disorder in the past 6 months
  • Cerebrovascular accident occurring in the past 6 months
  • Parkinson disease or neurological condition that limits mobility
  • Alzheimer disease or other forms of dementia
  • Conditions of concern to investigator that would confound orientation and mobility, such as severe arthritis, pain that limits ambulatory activities, or orthopedic surgery (e.g., hand, arm, shoulder, knee, or hip surgery within 12 months)

Treatment and study plan

SmartHMD version 1

Device

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

SmartHMD version 2

Device

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

SmartHMD version 3

Device

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

SmartHMD version 4

Device

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.

Primary outcomes

  1. Time-to-Complete

    Time frame: 2 hours

    Duration from start of trial to subject completing their assigned task (seconds).

Secondary outcomes

  1. Percentage of Preferred Walking Speed

    Time frame: 2 hours

    Percentage of preferred walking speed is a measure of how fast the participant is walking relative to their natural (or preferred) walking speed. Measure preferred walking speed was measured by having them walk with a researcher in an open area. Percentage preferred walking speed was obtained by dividing the measured walking speed during a trial by the preferred walking speed.

  2. Number of Unintended Contacts With Obstacles and Walls

    Time frame: 2 hours

    This outcome measure only applies to the RGBD & Jetson Indoor Test, as there were no walls/obstacles relevant in the other tests.

  3. Number of Incorrect Turns

    Time frame: 2 hours

    Number of incorrect turns or responses to device cues during testing.

  4. Number of Interventions

    Time frame: 2 hours

    Upon real-world application of the study protocol, the outcome measure originally conceived of as "requests for assistance" became pragmatically inseparable from "number of interventions" by study staff. Therefore, the two measures have been combined and are presented here as "number of interventions". The types of assistance requested could not be categorized, as they were not collected.

Sponsors and collaborators

Lead sponsor

James Weiland

Other

Registry information

Official study title

Smart Head Mounted Display (smartHMD) for Improved Mobility

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2018
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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