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Head Mounted Display for Low Vision

N/A
Recruiting
Led By James Weiland, PhD
Research Sponsored by James Weiland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self reported difficulty with mobility and finding doors (either indoors or outdoors) and using signalized crosswalks
Ability to cooperate for tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

Study Summary

This trial will test whether or not a head mounted display system can help improve orientation and mobility for individuals with low vision, potentially decreasing falls and improving everyday activities and quality of life.

Who is the study for?
This trial is for individuals diagnosed with low vision who can use a smartphone and participate in all study visits. They should have difficulty with mobility, particularly finding doors and using signalized crosswalks. Participants are split into two groups based on their vision quality. Those with recent ocular issues, major surgeries, neurological conditions like Parkinson's or Alzheimer's, unstable diabetes or retinopathy, pregnancy, or inability to use the HMD technology cannot join.Check my eligibility
What is being tested?
The study tests an intuitive head mounted display (HMD) system designed to help people with low vision navigate streets more safely and independently. It compares three scenarios: no HMD used, HMD worn but inactive, and HMD active while crossing at signaled crosswalks.See study design
What are the potential side effects?
While not explicitly mentioned in the provided information, potential side effects may include discomfort from wearing the device, eye strain from prolonged use of visual aids within the HMD if it has a display component or distraction leading to increased risk of accidents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have trouble moving around and finding doors or using crosswalks.
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I can follow instructions for medical tests.
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I can attend all required visits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mobility accuracy: Percentage Correct Alignment
Mobility accuracy: Percentage Cue Usage
Mobility accuracy: Veering
Secondary outcome measures
Detection of Signal
Time-to-Complete

Trial Design

1Treatment groups
Experimental Treatment
Group I: HMDExperimental Treatment3 Interventions
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.

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Who is running the clinical trial?

James WeilandLead Sponsor
James Weiland, PhDPrincipal Investigator - University of Michigan
University of Michigan

Media Library

Limited Mobility Clinical Trial 2023: SmartHMD Highlights & Side Effects. Trial Name: NCT03781583 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age restriction of this experiment limited to persons 30 years old or younger?

"As per the study's admission requirements, individuals between 14 and 89 years old are eligible to participate."

Answered by AI

Are new participants still being welcomed into this experiment?

"As evidenced on clinicaltrials.gov, this medical trial is currently enrolling participants. The study was first uploaded on April 26th 2019 and its most recent update came about 3 years later on April 20th 2022."

Answered by AI

What is the current sample size for this clinical investigation?

"Affirmative. Clinicaltrials.gov documents this medical investigation, which was originally made available on April 26th 2019, is now open for enrollment. The study needs to admit 30 patients from a single site."

Answered by AI

Are there opportunities for me to participate in this study?

"To qualify for consideration, individuals should be cognizant and aged between 14 to 89 years old. Around thirty patients are being recruited into this trial."

Answered by AI
~5 spots leftby Mar 2025