Opti Gait Wearable Gait Tracker

NCT07158580 | Not Yet Recruiting

• 5 other identifiers: 2025-1220R33AG061699-06ENGR/ELECTRICAL & COMPUTER ENGASProtocol Version 8/13/2025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Seniors

Outcome Measures

Primary Outcomes (3)

• Change in walking speed

  Participants will walk 4 meters with and without the shoe mounted device to assess the change in walking speed

  3 hours

• Change in natural gait

  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.

  3 hours

• Gait height

  Participants will climb a flight of five stairs, wearing the device, to measure gait height.

  3 hours

Study Arms (1)

No gait or mobility issues

Participants aged 65 or older who are able to walk for at least 10 minutes and can walk up and down a flight of stairs

Device: Gait Tracker

Interventions

Gait Tracker DEVICE

Opti Gait is a wearable gait tracker

Also known as: OptiGait Wearable Gait Tracker

No gait or mobility issues

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 65 years and older that have low technology literacy, and are from underserved urban and rural areas.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Jayer Fernandes, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayer Fernandes, PhD

CONTACT

608-358-3799; jfernandes@wisc.edu

Kristen Pickett, PhD

CONTACT

kristen.pickett@wisc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 8, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 1, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)