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SmartHMD for Improved Mobility

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ClinicalTrials.gov Identifier: NCT03781583
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
James Weiland, University of Michigan

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.


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

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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)
Primary Purpose: Other
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

Arm Intervention/treatment
Experimental: smartHMD
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.




Primary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. Detection of Signal [ Time Frame: 2 hours ]
    Percentage Trials subject correctly identified the displayed signal on the Pedestrian Signal (Yes/No Classification)

  2. Time-to-Complete [ Time Frame: 2 hours ]
    Duration from start of trial to subject locating the pedestrian signal (seconds)



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 89 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Binocular visual field < 20 degrees
  • Stratify vision with half best corrected vision better than or equal to 20/100, and other half best corrected vision worse than 20/100
  • Ability to use smart phone
  • Ability to cooperate for tests
  • Able to participate in all visits
  • Mini Mental State Examination (MMSE) score > 25 or MMSE-blind score > 17

Exclusion Criteria:

  • Visual field > 20 degrees in either eye
  • Unable to use head mounted display or smart phone technology
  • Use of leader dog
  • 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)

Information from the National Library of Medicine

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


Contacts
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Contact: V Swetha Jeganathan, MD 7345126456 jvswetha@med.umich.edu

Locations
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United States, Michigan
North Campus Research Complex Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: V Swetha Jeganathan    734-512-6456    jvswetha@med.umich.edu   
Sponsors and Collaborators
James Weiland
Investigators
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Principal Investigator: James Weiland, PhD University of Michigan

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Responsible Party: James Weiland, Professor of Biomedical Engineering, University of Michigan
ClinicalTrials.gov Identifier: NCT03781583     History of Changes
Other Study ID Numbers: HUM00141598
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Mobility Limitation
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms