Low VisionNCT03781583
SmartHMD for Improved Mobility
A study testing SmartHMD version 1, SmartHMD version 2 and SmartHMD version 3 in people with Low Vision and Orientation, run by James Weiland at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Vision, Orientation, Mobility Limitation
- What is being tested?
- SmartHMD version 1, SmartHMD version 2 and SmartHMD version 3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2019to 7 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
North Campus Research Complex
Ann Arbor, Michigan, 48105
About this study
Official title: 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.
Read the 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.
- Being tested
- SmartHMD version 1, SmartHMD version 2, SmartHMD version 3, SmartHMD version 4
- Medical subject headings
- Vision, Low, Orientation, Spatial, Mobility Limitation, Spatial Navigation, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartHMD version 1Device
First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds.
SmartHMD version 2Device
Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones.
SmartHMD version 3Device
Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software.
SmartHMD version 4Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SmartHMD version 1 |
| 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. Receives: Device: SmartHMD version 2 |
| 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. Receives: Device: SmartHMD version 3 |
| 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. Receives: Device: SmartHMD version 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-to-Complete
Duration from start of trial to subject completing their assigned task (seconds).
Measured: 2 hours
Secondary outcomes (4)
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.
Measured: 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.
Measured: 2 hours
Number of Incorrect Turns
Number of incorrect turns or responses to device cues during testing.
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start26 Apr 2019
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low VisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Testing will be done in three conditions: baseline (no HMD), sham (smartHMD worn but not active), and smartHMD (smartHMD worn and active)
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- James Weiland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Weiland, University of Michigan
- Investigators
- James Weiland, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781583
- Sponsor's protocol ID
- HUM00141598
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2018
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Head Mounted Display (smartHMD) for Improved Mobility
- ClinicalTrials.gov ID
- NCT03781583
- Acronym / sponsor ID
- HUM00141598
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- James WeilandUniversity, hospital or other
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Testing will be done in three conditions: baseline (no HMD), sham (smartHMD worn but not active), and smartHMD (smartHMD worn and active)
| Arm | Type | Receives |
|---|---|---|
| Outdoor and ODG | Experimental | Device: SmartHMD version 1Participants 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. |
| Indoor and Laptop | Experimental | Device: SmartHMD version 2Participants 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. |
| RGBD & Jetson - Indoor Course | Experimental | Device: SmartHMD version 3Participants 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. |
| RGBD & Jetson - Outdoor Crosswalk | Experimental | Device: SmartHMD version 4Participants 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. |
Who may qualify
- Ages
- 14 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmartHMD version 1First version of the SmartHMD device, which used custom software running on commercially available ODG R7 smart glasses and accompanying earbuds. | Device | Outdoor and ODG |
| SmartHMD version 2Second version of the SmartHMD device, which uses RGB-D smart glasses, custom software running on a laptop, and bone-conducting earphones. | Device | Indoor and Laptop |
| SmartHMD version 3Third iteration of the SmartHMD device, which uses RGB-D smart glasses, bone-conducting earphones, a Jetson mobile computer, and custom software. | Device | RGBD & Jetson - Indoor Course |
| SmartHMD version 4Fourth 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. | Device | RGBD & Jetson - Outdoor Crosswalk |
Primary outcome
Time-to-Complete
Time frame: 2 hours
Duration from start of trial to subject completing their assigned task (seconds).
4 secondary outcomes
Percentage of Preferred Walking Speed
Time frame: 2 hours
Number of Unintended Contacts With Obstacles and Walls
Time frame: 2 hours
Number of Incorrect Turns
Time frame: 2 hours
Number of Interventions
Time frame: 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Weiland, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SmartHMD version 1, SmartHMD version 2 and SmartHMD version 3 in people with Low Vision and Orientation, run by James Weiland at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-to-Complete (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.