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SmartHMD for Improved Mobility

Primary Purpose

Low Vision, Orientation, Mobility Limitation

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No HMD used
HMD worn but not active
HMD worn and active
Sponsored by
James Weiland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Low Vision

Eligibility Criteria

14 Years - 89 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed with low vision
  • Self reported difficulty with mobility and finding doors (either indoors or outdoors) and using signalized crosswalks.
  • 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

Exclusion Criteria:

  • Unable to use head mounted display or smart phone 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
  • 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)

Sites / Locations

  • North Campus Research ComplexRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HMD

Arm Description

We have several versions (listed below) of a headworn smartHMD. Each can provide verbal and/or tactile feedback to the user. Feedback is controlled by either the experimenter or by computer vision algorithms. 1. The ODG Smartglasses is commercially available. This system uses computer vision to guide a user to the destination using audio and/ or vibration feedback. 2) Tactile stimulator array. This device uses an Arduino Micro, HC-05 Bluetooth Module, L293D Motor Driver and coin vibration motors attached to a head-worn headband or glasses frame. The motors can be controlled directly by an experimenter or by computer vision algorithms. 3) Computer Vision Navigation prototyping system consists of two components: Intel RealSense camera and Alienware M15 laptop. All participants will receive the same 3 interventions: no HMD used, HMD worn but not active, and HMD worn and active. Participants may be tested with any or all of the systems described above.

Outcomes

Primary Outcome Measures

Mobility accuracy: Percentage Correct Alignment
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
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
Percentage Times subject needed cues from smartHMD and how well they responded to the cues (smartHMD condition only)

Secondary Outcome Measures

Detection of Signal
Percentage Trials subject correctly identified the displayed signal on the Pedestrian Signal (Yes/No Classification)
Time-to-Complete
Duration from start of trial to subject locating the pedestrian signal (seconds)

Full Information

First Posted
December 12, 2018
Last Updated
February 23, 2023
Sponsor
James Weiland
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1. Study Identification

Unique Protocol Identification Number
NCT03781583
Brief Title
SmartHMD for Improved Mobility
Official Title
Smart Head Mounted Display (smartHMD) for Improved Mobility
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
February 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
James Weiland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision, Orientation, Mobility Limitation, Navigation, Spatial, Visual Impairment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HMD
Arm Type
Experimental
Arm Description
We have several versions (listed below) of a headworn smartHMD. Each can provide verbal and/or tactile feedback to the user. Feedback is controlled by either the experimenter or by computer vision algorithms. 1. The ODG Smartglasses is commercially available. This system uses computer vision to guide a user to the destination using audio and/ or vibration feedback. 2) Tactile stimulator array. This device uses an Arduino Micro, HC-05 Bluetooth Module, L293D Motor Driver and coin vibration motors attached to a head-worn headband or glasses frame. The motors can be controlled directly by an experimenter or by computer vision algorithms. 3) Computer Vision Navigation prototyping system consists of two components: Intel RealSense camera and Alienware M15 laptop. All participants will receive the same 3 interventions: no HMD used, HMD worn but not active, and HMD worn and active. Participants may be tested with any or all of the systems described above.
Intervention Type
Device
Intervention Name(s)
No HMD used
Intervention Description
Participants will use their existing mobility skills and strategies to navigate toward a goal. If the participant cannot perform this task, the participant will not be forced to.
Intervention Type
Device
Intervention Name(s)
HMD worn but not active
Intervention Description
Participants will wear the HMD, but the HMD will not be active. This will test whether or not the HMD physical components obscure the participants remaining vision and reduce the participants ability to navigate toward a goal.
Intervention Type
Device
Intervention Name(s)
HMD worn and active
Intervention Description
Participants will wear the HMD and the HMD will be active. This will test the HMD function for navigation toward a goal.
Primary Outcome Measure Information:
Title
Mobility accuracy: Percentage Correct Alignment
Description
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.
Time Frame
2 hours
Title
Mobility accuracy: Veering
Description
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)
Time Frame
2 hours
Title
Mobility accuracy: Percentage Cue Usage
Description
Percentage Times subject needed cues from smartHMD and how well they responded to the cues (smartHMD condition only)
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Detection of Signal
Description
Percentage Trials subject correctly identified the displayed signal on the Pedestrian Signal (Yes/No Classification)
Time Frame
2 hours
Title
Time-to-Complete
Description
Duration from start of trial to subject locating the pedestrian signal (seconds)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed with low vision Self reported difficulty with mobility and finding doors (either indoors or outdoors) and using signalized crosswalks. 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 Exclusion Criteria: Unable to use head mounted display or smart phone 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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Weiland, PhD
Phone
(734) 764-9793
Email
weiland@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Weiland, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Campus Research Complex
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Weiland
Phone
734-764-9793
Email
weiland@umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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SmartHMD for Improved Mobility

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