N/A
N=18
SmartHMD for Improved Mobility
Low Vision · Orientation · Mobility Limitation · Navigation, Spatial · Visual Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03781583 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Time-to-Complete — 14.75; 32.75; 148.17; 17.3 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SmartHMD version 1 (Device); SmartHMD version 2 (Device); SmartHMD version 3 (Device); SmartHMD version 4 (Device)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- James Weiland
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-Complete |
14.75; 32.75; 148.17; 17.3 | — |
| SECONDARY Percentage of Preferred Walking Speed |
67.2; 95.76 | — |
| SECONDARY Number of Unintended Contacts With Obstacles and Walls |
— | — |
| SECONDARY Number of Incorrect Turns |
0; 1 | — |
| SECONDARY Number of Interventions |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT03781583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.