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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-to-Complete | Duration from start of trial to subject completing their assigned task (seconds). | 2 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Weiland, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Campus Research Complex | Ann Arbor | Michigan | 48105 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Cohort C: RGBD & Jetson - Indoor Course | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The numbers shown in each arm below represent one person beginning in that cohort.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age information was not collected |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-Complete | Duration from start of trial to subject completing their assigned task (seconds). | Data are not included for those participants who did not show up, equipment malfunctions or persons unable to complete the task. | Posted | Mean | Full Range | Seconds | 2 hours |
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AEs could have been collected during on-site participation, up to two hours. Follow-up calls took place two weeks later, during which participants could have reported AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Outdoor and ODG Test Participants | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Weiland | University of Michigan Medical School | 734-764-9793 | weiland@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2021 | Jul 31, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| D000072458 | Orientation, Spatial |
| D051346 | Mobility Limitation |
| D065854 | Spatial Navigation |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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Testing will be done in three conditions: baseline (no HMD), sham (smartHMD worn but not active), and smartHMD (smartHMD worn and active)
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| Technology did not work for that person in that environment |
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| Participant was not sufficiently visually impaired |
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| Pilot test of course took place in different location, data not comparable to other participant data |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Preferred Walking Speed | Baseline Measure data was only collected for tests C and D. | Baseline Measure data was only collected for tests C and D. | Mean | Full Range | meters/second |
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| Units |
|---|
| Counts |
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| Participants |
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| 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. | 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. | Posted | Mean | Full Range | percentage of preferred walking speed | 2 hours |
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| 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. | This includes all participants who completed this test and for whom usable data was collected. | Posted | Mean | Full Range | Count of contacts | 2 hours |
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| Secondary | Number of Incorrect Turns | Number of incorrect turns or responses to device cues during testing. | Data was only collected for the RGBD & Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test | Posted | Median | Full Range | Count of incorrect turns | 2 hours |
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| 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. | Data was only collected for the RGBD & Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test | Posted | Median | Full Range | Counts of interventions | 2 hours |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Cohort B: Indoor and Laptop Test Participants | 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. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Cohort C: RGBD & Jetson - Indoor Test Participants | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants | 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. Participants use the device to navigate their way through an outdoor crosswalk. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013037 | Spatial Behavior |
| D001519 | Behavior |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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