SeniorsNCT07158580
Opti Gait Wearable Gait Tracker
An observational study of Seniors, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seniors
- What is being tested?
- Gait Tracker
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Adults aged 65 years and older that have low technology literacy, and are from underserved urban and rural areas.
Who may be able to join
- Aged 65 years and older
- Able to speak and understand English,
- Able to provide consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Pickett, PhD contact
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Jayer Fernandes, PhD, 608-358-3799, jfernandes@wisc.edu
About this study
Official title: Opti Gait Wearable Gait Tracker: Pilot Trial l With Healthy Older Adults
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.
Read the 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.
- Conditions
- Seniors
- Being tested
- Gait Tracker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait TrackerDevice
Also called OptiGait Wearable Gait Tracker
Opti Gait is a wearable gait tracker
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Gait Tracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed
Participants will walk 4 meters with and without the shoe mounted device to assess the change in walking speed
Measured: 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.
Measured: 3 hours
Gait height
Participants will climb a flight of five stairs, wearing the device, to measure gait height.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeniorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jayer Fernandes, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158580
- Sponsor's protocol ID
- 2025-1220
- Other IDs
- R33AG061699-06, ENGR/ELECTRICAL & COMPUTER ENG, AS, Protocol Version 8/13/2025
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opti Gait Wearable Gait Tracker: Pilot Trial l With Healthy Older Adults
- ClinicalTrials.gov ID
- NCT07158580
- Acronym / sponsor ID
- 2025-1220
- Conditions
- Seniors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No gait or mobility issues | – | Device: Gait TrackerParticipants aged 65 or older who are able to walk for at least 10 minutes and can walk up and down a flight of stairs |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Adults aged 65 years and older that have low technology literacy, and are from underserved urban and rural areas.
Key inclusion criteria (3 listed)
- Aged 65 years and older
- Able to speak and understand English,
- Able to provide consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait TrackerAlso: OptiGait Wearable Gait TrackerOpti Gait is a wearable gait tracker | Device | No gait or mobility issues |
Primary outcome
Change in walking speed
Time frame: 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
Time frame: 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
Time frame: 3 hours
Participants will climb a flight of five stairs, wearing the device, to measure gait height.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristen Pickett, PhD contact
Jayer Fernandes, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seniors, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jayer Fernandes, PhD (608-358-3799, jfernandes@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.