Trial Outcomes & Findings for SmartHMD for Improved Mobility (NCT NCT03781583)
NCT ID: NCT03781583
Last Updated: 2024-12-12
Results Overview
Duration from start of trial to subject completing their assigned task (seconds).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
2 hours
Results posted on
2024-12-12
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
8
|
1
|
|
Overall Study
Participated and Completed Indoor Doorfinding Test
|
1
|
3
|
0
|
0
|
|
Overall Study
RGBD & Jetson Test
|
0
|
2
|
8
|
0
|
|
Overall Study
RGBD Outdoor Crosswalk Test
|
0
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
2
|
3
|
8
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
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
|
|
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
|
Baseline Characteristics
Age information was not collected
Baseline characteristics by cohort
| Measure |
Cohort A: Outdoor and ODG
n=4 Participants
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.
|
Cohort B: Indoor and Laptop
n=5 Participants
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.
|
Cohort C: RBDG & Jetson -Indoor
n=8 Participants
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.
|
Cohort D: RGBD & Jetson - Outdoor Crosswalk
n=1 Participants
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.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
0 Participants
Age information was not collected
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=1 Participants
|
10 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
8 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=1 Participants
|
18 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=1 Participants
|
18 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=8 Participants
|
1 Participants
n=1 Participants
|
18 Participants
n=18 Participants
|
|
Preferred Walking Speed
Preferred walking speed of those testing the indoor course (Test C)
|
—
|
.622 meters/second
n=2 Participants • Baseline Measure data was only collected for tests C and D.
|
.968 meters/second
n=8 Participants • Baseline Measure data was only collected for tests C and D.
|
—
|
.899 meters/second
n=10 Participants • Baseline Measure data was only collected for tests C and D.
|
|
Preferred Walking Speed
Preferred walking speed of those testing the outdoor course (Test D)
|
—
|
.817 meters/second
n=1 Participants • Baseline Measure data was only collected for tests C and D.
|
0.76 meters/second
n=1 Participants • Baseline Measure data was only collected for tests C and D.
|
1.15 meters/second
n=1 Participants • Baseline Measure data was only collected for tests C and D.
|
.909 meters/second
n=3 Participants • Baseline Measure data was only collected for tests C and D.
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Data are not included for those participants who did not show up, equipment malfunctions or persons unable to complete the task.
Duration from start of trial to subject completing their assigned task (seconds).
Outcome measures
| Measure |
Study Participants
n=16 Participants
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.
|
|---|---|
|
Time-to-Complete
Outdoor Crosswalk with ODG Test
|
14.75 Seconds
Interval 13.0 to 17.0
|
|
Time-to-Complete
Indoor Door Finding Test
|
32.75 Seconds
Interval 18.0 to 55.0
|
|
Time-to-Complete
Indoor Course Navigation Test
|
148.17 Seconds
Interval 40.0 to 479.0
|
|
Time-to-Complete
Outdoor Crosswalk with RGBD, Jetson New Software Test
|
17.3 Seconds
Interval 12.15 to 20.2
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Study Participants
n=11 Participants
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.
|
|---|---|
|
Percentage of Preferred Walking Speed
RGBD & Jetson indoor test
|
67.2 percentage of preferred walking speed
Interval 26.6 to 150.0
|
|
Percentage of Preferred Walking Speed
RGBD and Jetson Outdoor Crosswalk test
|
95.76 percentage of preferred walking speed
Interval 86.5 to 104.25
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: This includes all participants who completed this test and for whom usable data was collected.
This outcome measure only applies to the RGBD \& Jetson Indoor Test, as there were no walls/obstacles relevant in the other tests.
Outcome measures
| Measure |
Study Participants
n=10 Participants
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.
|
|---|---|
|
Number of Unintended Contacts With Obstacles and Walls
|
0 Count of contacts
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Data was only collected for the RGBD \& Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test
Number of incorrect turns or responses to device cues during testing.
Outcome measures
| Measure |
Study Participants
n=11 Participants
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.
|
|---|---|
|
Number of Incorrect Turns
RGBD & Jetson indoor test
|
0 Count of incorrect turns
Interval 0.0 to 7.0
|
|
Number of Incorrect Turns
RGBD and Jetson Outdoor Crosswalk test
|
1 Count of incorrect turns
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: 2 hoursPopulation: Data was only collected for the RGBD \& Jetson indoor test and the RGBD and Jetson Outdoor Crosswalk test
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.
Outcome measures
| Measure |
Study Participants
n=11 Participants
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.
|
|---|---|
|
Number of Interventions
Indoor Course Navigation Test
|
0 Counts of interventions
Interval 0.0 to 5.0
|
|
Number of Interventions
Outdoor Crosswalk with RGBD, Jetson New Software Test
|
0 Counts of interventions
Interval 0.0 to 3.0
|
Adverse Events
Outdoor and ODG Test Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort B: Indoor and Laptop Test Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort C: RGBD & Jetson - Indoor Test Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort D: RGBD & Jetson - Outdoor Crosswalk Test Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place