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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insole and ankle device.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Dementia. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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.
Interventions
- Device Insole and ankle device
Device that is worn as a shoe insole and around the ankle which will measure gait parameters to detect cognitive decline
Primary outcome measures
- 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]
- In-Community Testing Primary Outcome: balanced accuracy of model developed using gait data [Time frame: One week]
Secondary outcome measures (3)
- In Lab Testing Secondary Outcome: Average score on user feedback survey [Time frame: Day 1]
- In Community Secondary Outcome: Average score on user feedback survey [Time frame: 1 week]
- In Community Secondary Outcome: Device Failure Rate [Time frame: 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- HealthPartners Neuroscience Center — Saint Paul
Identifiers
NCT: NCT07127133 · A24-016 · R44AG063679