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NCT07127133 · ClinicalTrials.gov registry record · NA
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)
A NA study, sponsored by HealthPartners Institute.
- Not yet
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT07127133: Clinical Trial NA study, sponsored by HealthPartners Institute.
NCT07127133 is a NA study that has not yet begun recruiting, run by HealthPartners Institute. The registered enrollment target is 150 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07127133, a NA study, has not yet begun recruiting, sponsored by HealthPartners Institute.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Mean Absolute Error (MAE) of the gait speed during the Short Physical Performance Battery (SPPB) and Timed Up and GO (TUG)
Interventions
- DEVICE Insole and ankle device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2027-08-31 |
| Phase | NA |
What is known before NCT07127133 opens enrollment
NCT07127133 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Insole and ankle device is the first listed.
NCT07127133 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07127133 about?
NCT07127133 is a clinical study titled "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, includin...
What is the current status of trial NCT07127133?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2026-08-01. Estimated completion is 2027-08-31.
What interventions are being tested in trial NCT07127133?
The interventions under investigation include: Insole and ankle device (DEVICE).
Who is sponsoring clinical trial NCT07127133?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07127133's enrollment target sits among peer trials
150 661st of 2000 higher than 1,299 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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