Low Vision, Mobility Limitation, Navigation, Spatial, Orientation, Visual Impairment
Conditions
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.
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.
Interventions
DEVICESmartHMD version 1
First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds.
DEVICESmartHMD version 2
Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones.
DEVICESmartHMD version 3
Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software.
DEVICESmartHMD 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
James Weiland
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Testing will be done in three conditions: baseline (no HMD), sham (smartHMD worn but not active), and smartHMD (smartHMD worn and active)
Eligibility
Sex/Gender
ALL
Age
14 Years to 89 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Complete | 2 hours | Duration from start of trial to subject completing their assigned task (seconds). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Preferred Walking Speed | 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. |
| Number of Unintended Contacts With Obstacles and Walls | 2 hours | This outcome measure only applies to the RGBD & Jetson Indoor Test, as there were no walls/obstacles relevant in the other tests. |
| Number of Incorrect Turns | 2 hours | Number of incorrect turns or responses to device cues during testing. |
| Number of Interventions | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of 21 people consented, 2 individuals failed post start-up screening, and 1 never came in for any assignment. That brings the 21 consented to 18. Participants could consent and enroll in multiple cohorts, reconsenting for each cohort in which they participated. The numbers shown in each arm represent each individual who initially enrolled in that cohort. Some continued on to participate in further tests, but no participant appears in more than one arm in Participant Flow.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A: Outdoor and ODG This cohort began their participation by testing this iteration of the SmartHMD device. Some participants, as shown below via milestones, also participated in subsequent tests.
SmartHMD version 1 assessed with Outdoor Crosswalk Test: 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. | 4 |
| Cohort B: Indoor and Laptop This cohort began their participation by testing this iteration of the SmartHMD device. Some participants, as shown below via milestones, also participated in subsequent tests.
SmartHMD version 2 assessed with Indoor Door Location Test: 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. | 5 |
| Cohort C: RBDG & Jetson -Indoor This cohort began their participation by testing this iteration of the SmartHMD device. Some participants, as shown below via milestones, also participated in subsequent tests.
SmartHMD assessed with 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. | 8 |
| Cohort D: RGBD & Jetson - Outdoor Crosswalk This cohort began their participation by testing this iteration of the SmartHMD device.
SmartHMD assessed with 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. | 1 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Participant was not sufficiently visually impaired | 0 | 1 | 0 | 0 |
| Overall Study | Pilot test of course took place in different location, data not comparable to other participant data | 0 | 1 | 0 | 0 |
| Overall Study | Technical issue prevents the device from starting properly | 1 | 0 | 0 | 0 |
| Overall Study | Technology did not work for that person in that environment | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort C: RBDG & Jetson -Indoor | Cohort B: Indoor and Laptop | Cohort A: Outdoor and ODG | Cohort D: RGBD & Jetson - Outdoor Crosswalk | Total |
|---|---|---|---|---|---|
| Age, Customized Age | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 4 Participants | 1 Participants | 18 Participants |
| Preferred Walking Speed Preferred walking speed of those testing the indoor course (Test C) | .968 meters/second | .622 meters/second | — | — | .899 meters/second |
| Preferred Walking Speed Preferred walking speed of those testing the outdoor course (Test D) | 0.76 meters/second | .817 meters/second | — | 1.15 meters/second | .909 meters/second |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 4 Participants | 1 Participants | 18 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 8 Participants | 5 Participants | 4 Participants | 1 Participants | 18 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 0 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants | 0 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 6 | 0 / 10 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 6 | 0 / 10 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 6 | 0 / 10 | 0 / 3 |
Outcome results
Primary
Time-to-Complete
Duration from start of trial to subject completing their assigned task (seconds).
Time frame: 2 hours
Population: Data are not included for those participants who did not show up, equipment malfunctions or persons unable to complete the task.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Participants | Time-to-Complete | Outdoor Crosswalk with ODG Test | 14.75 Seconds |
| Study Participants | Time-to-Complete | Indoor Door Finding Test | 32.75 Seconds |
| Study Participants | Time-to-Complete | Indoor Course Navigation Test | 148.17 Seconds |
| Study Participants | Time-to-Complete | Outdoor Crosswalk with RGBD, Jetson New Software Test | 17.3 Seconds |
Secondary
Number of Incorrect Turns
Number of incorrect turns or responses to device cues during testing.
Time frame: 2 hours
Population: Data was only collected for the RGBD \& Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Number of Incorrect Turns | RGBD & Jetson indoor test | 0 Count of incorrect turns |
| Study Participants | Number of Incorrect Turns | RGBD and Jetson Outdoor Crosswalk test | 1 Count of incorrect turns |
Secondary
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
Population: Data was only collected for the RGBD \& Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Participants | Number of Interventions | Indoor Course Navigation Test | 0 Counts of interventions |
| Study Participants | Number of Interventions | Outdoor Crosswalk with RGBD, Jetson New Software Test | 0 Counts of interventions |
Secondary
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
Population: This includes all participants who completed this test and for whom usable data was collected.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Participants | Number of Unintended Contacts With Obstacles and Walls | 0 Count of contacts |
Secondary
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
Population: Participants in this study could participate in multiple tests within the study. The total number in this arm reflects the number of unique participants. The number analyzed within each test reflects the number of participants who participated in that specific test and for whom usable data was collected. Some participants did participate in more than one test.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Study Participants | Percentage of Preferred Walking Speed | RGBD & Jetson indoor test | 67.2 percentage of preferred walking speed |
| Study Participants | Percentage of Preferred Walking Speed | RGBD and Jetson Outdoor Crosswalk test | 95.76 percentage of preferred walking speed |