SmartHMD for Improved Mobility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03781583|
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : May 16, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Low Vision Orientation Mobility Limitation Navigation, Spatial Visual Impairment||Device: No smartHMD used Device: smartHMD worn but not active Device: smartHMD worn and active||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|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)|
|Masking:||None (Open Label)|
|Official Title:||Smart Head Mounted Display (smartHMD) for Improved Mobility|
|Actual Study Start Date :||April 26, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2022|
The ODG R-7 Smartglasses (ODG, San Francisco) system is commercially available and designed for human use. The ODG R-7 has a camera, microprocessors, and microdisplays in front of each eye. The device has been programmed to obtain scene information for the detection and guidance modules. The detection module identifies places or objects of interest in a scene while tracking and detecting any changes. The guidance module plans an optimal path, based on the detected objects, and guides the user to the destination using audio and/ or vibration feedback. All participants will receive the same 3 interventions: no smartHMD used, smartHMD worn but not active, and smartHMD worn and active.
Device: No smartHMD used
Participants will use their existing mobility skills and strategies to navigate a signaled crosswalk. If the participant cannot perform this task, the participant will not be forced to.
Device: smartHMD worn but not active
Participants will wear the smartHMD, but the smartHMD will not be active. This will test whether or not the smartHMD physical components obscure the participants remaining vision and reduce the participants ability to navigate a signaled crosswalk.
Device: smartHMD worn and active
Participants will wear the smartHMD and the smartHMD will be active. This will test the smartHMD function for crosswalk navigation.
- Mobility accuracy: Percentage Correct Alignment [ Time Frame: 2 hours ]Percentage Trials correctly aligned at the crosswalk (Yes/No Classification). Alignment of feet position relative to lines on sidewalk parallel to street and perpendicular to crosswalk. +/- 10 degrees will be considered correct.
- Mobility accuracy: Veering [ Time Frame: 2 hours ]The amount of deviation, in degrees, from optimal path (Optimal path for baseline and sham conditions: straight down the middle of pathway; optimal path for smartHMD condition: cued path from smartHMD)
- Mobility accuracy: Percentage Cue Usage [ Time Frame: 2 hours ]Percentage Times subject needed cues from smartHMD and how well they responded to the cues (smartHMD condition only)
- Detection of Signal [ Time Frame: 2 hours ]Percentage Trials subject correctly identified the displayed signal on the Pedestrian Signal (Yes/No Classification)
- Time-to-Complete [ Time Frame: 2 hours ]Duration from start of trial to subject locating the pedestrian signal (seconds)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781583
|Contact: V Swetha Jeganathan, MDemail@example.com|
|United States, Michigan|
|North Campus Research Complex||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: V Swetha Jeganathan 734-512-6456 firstname.lastname@example.org|
|Principal Investigator:||James Weiland, PhD||University of Michigan|