NCT03781583

SmartHMD for Improved Mobility

Completed NA Results posted Last updated 12 December 2024

What this trial tests

NA trial testing SmartHMD version 1 in Low Vision in 21 participants. Completed in 7 November 2022.

Timeline

26 April 2019

Primary endpoint
7 November 2022

7 November 2022

Quick facts

Lead sponsor	James Weiland
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	21
Start date	26 April 2019
Primary completion	7 November 2022
Estimated completion	7 November 2022
Sites	1 location across United States

Drugs / interventions tested

• SmartHMD version 1
• SmartHMD version 2
• SmartHMD version 3
• SmartHMD version 4

Conditions studied

• Low Vision — all drugs for Low Vision →
• Orientation — all drugs for Orientation →
• Mobility Limitation — all drugs for Mobility Limitation →
• Navigation, Spatial — all drugs for Navigation, Spatial →

Sponsor

James Weiland

Who can join

Adults 14 to 89, any sex, with Low Vision or Orientation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-to-Complete Primary · 2 hours

Duration from start of trial to subject completing their assigned task (seconds).

Outdoor Crosswalk with ODG Test

Group	Value	95% CI
Study Participants	14.75	13 – 17

Indoor Door Finding Test

Group	Value	95% CI
Study Participants	32.75	18 – 55

Indoor Course Navigation Test

Group	Value	95% CI
Study Participants	148.17	40 – 479

Outdoor Crosswalk with RGBD, Jetson New Software Test

Group	Value	95% CI
Study Participants	17.3	12.15 – 20.2

Percentage of Preferred Walking Speed Secondary · 2 hours

Percentage of preferred walking speed is a measure of how fast the participant is walking relative to their natural (or preferred) walking speed. Measure preferred walking speed was measured by having them walk with a researcher in an open area. Percentage preferred walking speed was obtained by dividing the measured walking speed during a trial by the preferred walking speed.

RGBD & Jetson indoor test

Group	Value	95% CI
Study Participants	67.2	26.6 – 150

RGBD and Jetson Outdoor Crosswalk test

Group	Value	95% CI
Study Participants	95.76	86.5 – 104.25

Number of Unintended Contacts With Obstacles and Walls Secondary · 2 hours

This outcome measure only applies to the RGBD \& Jetson Indoor Test, as there were no walls/obstacles relevant in the other tests.

Group	Value	95% CI
RGBD & Jetson Test (Indoor Course)	0	0 – 0

Number of Incorrect Turns Secondary · 2 hours

Number of incorrect turns or responses to device cues during testing.

RGBD & Jetson indoor test

Group	Value	95% CI
Study Participants	0	0 – 7

RGBD and Jetson Outdoor Crosswalk test

Group	Value	95% CI
Study Participants	1	0 – 8

Number of Interventions Secondary · 2 hours

Upon real-world application of the study protocol, the outcome measure originally conceived of as "requests for assistance" became pragmatically inseparable from "number of interventions" by study staff. Therefore, the two measures have been combined and are presented here as "number of interventions". The types of assistance requested could not be categorized, as they were not collected.

Indoor Course Navigation Test

Group	Value	95% CI
Study Participants	0	0 – 5

Outdoor Crosswalk with RGBD, Jetson New Software Test

Group	Value	95% CI
Study Participants	0	0 – 3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.