Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: 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)

This study tests an innovative system and service for collecting objective, consistent, and in-community gait parameters suitable for use as AD/ADRD biomarkers. The system is designed to be affordable, scalable, and practical for longitudinal, unsupervised, in-community use by older adults, including those with dementia symptoms. This study will be performed in two parts and involves collecting gait data from participants using the leg module and insole device either (1) for several hours in a lab setting (in-lab testing) or (2) within their home and community for 1 week (in-community testing). Thirty people who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-lab testing, in which they will perform walking tasks and cognitive testing for several hours within a lab environment. After completion of in-lab testing, 120 individuals who are healthy, have mild cognitive impairment, or who have Alzheimer's disease or related dementia will be recruited to participate in the in-community testing, in which they will wear the insole and ankle device within their community for 1-week for collection of gait data in real world settings.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mild Cognitive Impairment (MCI) Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location contact

Amanda Herrmann, PhD

PRINCIPAL_INVESTIGATOR

Clinical Research Coordinator

CONTACT

[email protected]

651-495-6363

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insole and ankle device

Device

Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline

Primary outcomes

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

    Time frame: Day 1

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

  2. In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data

    Time frame: One week

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

Secondary outcomes

  1. In Lab Testing Secondary Outcome: Average score on user feedback survey

    Time frame: Day 1

    Survey is on 5-point Likert scale, with higher score being more positive feedback.

  2. In Community Secondary Outcome: Average score on user feedback survey

    Time frame: 1 week

    Survey is 5-point Likert scale, with higher score being more positive feedback.

  3. In Community Secondary Outcome: Device Failure Rate

    Time frame: 1 week

    Mechanical and software failures reported as per subject per day worn rate

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Innovative Design Labs
  • National Institute on Aging (NIA)

Registry information

Official study title

A Gait and Path Tortuosity System for Monitoring Cognitive Decline in Individuals at Risk for Alzheimer's Disease and/or Alzheimer's Disease Related Dementias (AD/ADRD)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2025
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.