SmartHMD for Improved Mobility

NCT03781583 | Completed Results FDA Device

• 1 other identifier: HUM00141598
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Time-to-Complete

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

  2 hours

Secondary Outcomes (4)

• Percentage of Preferred Walking Speed

  2 hours

• Number of Unintended Contacts With Obstacles and Walls

  2 hours

• Number of Incorrect Turns

  2 hours

• Number of Interventions

  2 hours

Study Arms (4)

Outdoor and ODG

EXPERIMENTAL

Participants used the first version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds. Participants used the device to navigate across an outdoor crosswalk.

Device: SmartHMD version 1

Indoor and Laptop

EXPERIMENTAL

Participants use the second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones. Participants use the device to locate the door within an indoor course.

Device: SmartHMD version 2

RGBD & Jetson - Indoor Course

EXPERIMENTAL

Participants use a new iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software. Participants use the device to navigate their way through an indoor course.

Device: SmartHMD version 3

RGBD & Jetson - Outdoor Crosswalk

EXPERIMENTAL

Participants use the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and a specific version of custom software. Participants use the device to navigate their way through an outdoor crosswalk.

Device: SmartHMD version 4

Interventions

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.

Outdoor and ODG

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.

Indoor and Laptop

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.

RGBD & Jetson - Indoor Course

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.

RGBD & Jetson - Outdoor Crosswalk

Eligibility Criteria

• Age: 14 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• James Weiland: lead

Study Sites (1)

North Campus Research Complex

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Vision, Low; Orientation, Spatial; Mobility Limitation; Spatial Navigation; Vision Disorders

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spatial Behavior; Behavior

Results Point of Contact

• Title: James Weiland
• Organization: University of Michigan Medical School

weiland@umich.edu

734-764-9793

Study Officials

• James Weiland, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Biomedical Engineering

Model Details: Testing will be done in three conditions: baseline (no HMD), sham (smartHMD worn but not active), and smartHMD (smartHMD worn and active)

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 20, 2018
• Study Start: April 26, 2019
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)