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.
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
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
21
First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds.
Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones.
Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software.
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.
North Campus Research Complex
Ann Arbor, Michigan, United States
Time-to-Complete
Duration from start of trial to subject completing their assigned task (seconds).
Time frame: 2 hours
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.
Time frame: 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.
Time frame: 2 hours
Number of Incorrect Turns
Number of incorrect turns or responses to device cues during testing.
Time frame: 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.
Time frame: 2 hours
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