SmartHMD for Improved Mobility

Smart Head Mounted Display (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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation; Visual Impairment; Low Vision; Orientation; Navigation, Spatial
• Intervention / Treatment: Device: SmartHMD version 1; Device: SmartHMD version 2; Device: SmartHMD version 3; Device: SmartHMD version 4

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • North Campus Research Complex

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 89 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outdoor and ODG; 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; First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds.
Experimental: Indoor and Laptop; 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; Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones.
Experimental: RGBD & Jetson - Indoor Course; 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; Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software.
Experimental: RGBD & Jetson - Outdoor Crosswalk; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time-to-Complete	Duration from start of trial to subject completing their assigned task (seconds).	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Preferred Walking Speed	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 hours
Number of Unintended Contacts With Obstacles and Walls	This outcome measure only applies to the RGBD & Jetson Indoor Test, as there were no walls/obstacles relevant in the other tests.	2 hours
Number of Incorrect Turns	Number of incorrect turns or responses to device cues during testing.	2 hours
Number of Interventions	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.	2 hours

Collaborators and Investigators

• Sponsor: James Weiland
• Investigators: Principal Investigator: James Weiland, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2019
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Sensation Disorders; Vision, Low; Mobility Limitation; Vision Disorders
• Other Study ID Numbers: HUM00141598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes