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Wearable device tracks walking patterns to spot dementia risk

NCT ID NCT07127133

Diagnosis Sponsor: HealthPartners Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times

Summary

This study tests a wearable insole and ankle device that measures walking patterns to detect early cognitive decline in older adults. Researchers will collect gait data from 150 participants—some healthy, some with mild cognitive impairment or dementia—first in a lab and then during a week of everyday use at home. The goal is to see if the device can accurately identify people at risk for Alzheimer's disease or related dementias.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
wearable insole and ankle device
What this could lead to
If successful, this could provide a simple, at-home way to detect early cognitive decline, potentially leading to earlier diagnosis and monitoring of Alzheimer's disease.
What could go wrong
This is an early-stage study with only 150 participants, focused on measuring gait accuracy, not on treatment. The device may not reliably distinguish cognitive decline from normal aging or other conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 55 or older * Ability to ambulate without the use of an assistive device. For this study, we will assume participants are ambulatory if they can complete the functional outcome measures (i.e., TUG) without the use of an assistive device * Ability to understand and provide informed consent, or has a legally authorized representative (LAR) to provide consent on their behalf * Ability to don and doff the insole and leg module independently or have assistance for the duration of the study Exclusion Criteria: * Non-English Speaking * Use of ankle-foot orthosis for ambulation that prevents use of the system * Self-reported acute thrombophlebitis including deep vein thrombosis * Untreated lymphedema or lesion of any kind, swelling, infection, inflamed area of skin or eruptions on or near product use (foot and ankle) * Untreated fractures in the foot and ankle * Any other significant medical condition that may affect participation or performance in the study, as determined by investigators

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia Mild cognitive impairment (MCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesota, 55130, United States

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