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Monitoring Cognitive Decline with an Insole and Ankle Device

This study is testing an "Insole and ankle device" to see if it can help detect cognitive decline in people at risk for Alzheimer's disease or related dementias. The device, worn in a shoe and around the ankle, measures how you walk (gait parameters). The goal is to find an affordable and practical way to track changes in walking that might signal cognitive decline. To join, you must be 55 or older and able to walk without assistance. The study will look at how accurately the device measures walking speed in a lab setting, and how well a model developed from the device's data can identify changes over one week in your home and community. The current recruitment status is unclear, and the study plans to enroll 150 participants.

Study design
This is an interventional study planning to enroll 150 participants. It involves testing a device in two parts: either for several hours in a lab or for one week in your home and community.
What's involved
You would wear the leg module and insole device for several hours in a lab setting or for one week in your home and community. You would also complete functional tests like the Short Physical Performance Battery and Timed Up and Go.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at Day 1 for in-lab testing and at one week for in-community testing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07127133

An Insole and Ankle Device for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)

Not Yet Recruiting
NAAges 55+InterventionalDiagnostic
HealthPartners Institute
~150 participants
Updated 2026-09-15 on ClinicalTrials.gov
What's tested:Insole and ankle device

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and Go
Measured over Day 1
+1 more outcome measured

Conditions

Mild Cognitive Impairment (MCI)
Dementia

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NCT07127133

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • HealthPartners Neuroscience Center

    Saint Paul, Minnesotastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Clinical Research Coordinator
[email protected]
651-495-6363
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • In Lab Testing Primary Outcome: Mean absolute error of gait speed from the Short Physical Performance Battery and Timed Up and GoDay 1

    Mean Absolute Error (MAE) of the gait speed during the Short Physical Performance Battery (SPPB) and Timed Up and GO (TUG)

  • In-Community Testing Primary Outcome: balanced accuracy of model developed using gait dataOne week

    Balanced accuracy of cognitive impairment classification. This is the mean between recall of the positive and negative classes.