Opti Gait Wearable Gait Tracker

Not yet recruiting

• Conditions: Seniors

• Registration Number: NCT07158580
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

The purpose of this observational study is to test a shoe mounted gait monitoring device that was refined with the input of older adults and assess the efficacy of the refinements through a series of tests that involve walking with and without the device.

Detailed Description

In this testing, researchers seek to validate the precision, accuracy and robustness of the community-corefined device with healthy older adults, aged 65 years and above, by conducting walking tests on a state of the art GaitRite gaitmat to assess various gait metrics and on a flight of stairs to assess gait height. Following this, researchers will conduct a semi structured interview that will comprise a series of yes/no questions and open ended questions to understand the efficacy of the refinements and further refinement directions.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Study First Posted: 2025-09-08
• Last Update Submitted: 2025-10-15
• Last Update Posted: 2025-10-20
• Study Start: 2025-11-01
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Aged 65 years and older
• Able to speak and understand English,
• Able to provide consent

Exclusion Criteria

• Current or recent (< 1 year) major psychiatric condition
• Significant medical condition such that usability evaluation could pose substantial health or safety risk
• Individuals with an activated power of attorney will be excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in walking speed	3 hours	Participants will walk 4 meters with and without the shoe mounted device to assess the change in walking speed
Change in natural gait	3 hours	Participants will walk on a gait mat to assess natural gait, and then will walk on the gait mat wearing the device to assess the change in natural gait. Gait metrics captured by OptiGait will be compared with those captured by GaitRite to understand accuracy and precision.
Gait height	3 hours	Participants will climb a flight of five stairs, wearing the device, to measure gait height.

Trial Locations

Locations (1)

University of Wisconsin - Madison; 🇺🇸 Madison, Wisconsin, United States