Insole and Ankle Device for Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new insole and ankle device designed to gather important movement data for individuals with dementia or similar cognitive issues. The device collects information on walking patterns, which might aid in diagnosing or tracking Alzheimer's and related conditions. Participants will wear the device in a lab for a few hours and at home and in their community for a week. Suitable candidates are those aged 55 or older who can walk without a cane or walker and have mild cognitive issues or dementia symptoms. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance understanding and management of cognitive conditions.
Do I need to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that this device is safe for use in individuals with dementia?
Research has shown that wearable devices like the insole and ankle device are generally safe. Studies on similar technology have found no major issues with their use. For example, smart insoles that monitor walking patterns have undergone extensive testing and revealed no problems, even after many uses.
These devices are easy to use, allowing people to wear them with minimal discomfort or side effects. The technology in these insoles already tracks walking patterns and assists with health checks. Overall, evidence suggests that this type of device is safe for everyday use.12345Why are researchers excited about this trial?
Researchers are excited about the insole and ankle device for dementia because it offers a non-invasive, wearable option that could potentially improve mobility and cognitive function. Unlike standard medications that target neurotransmitters, this device uses real-time data collection to monitor and potentially enhance physical activity and movement patterns. The unique aspect of this treatment is its ability to be used both in a controlled lab setting and in the comfort of a patient's home, providing a flexible and user-friendly approach to managing dementia symptoms.
What evidence suggests that this insole and ankle device is effective for dementia?
Research has shown that insoles can help older adults improve balance and gait. A review of several studies found that insoles enhance standing balance and walking ability immediately after use. Another study found that both flat and textured insoles effectively help older people maintain balance. These findings suggest that insoles might assist individuals with Alzheimer's disease or related dementias by improving movement and stability. In this trial, participants will use the insole and ankle device, which could monitor and enhance walking in everyday life.13678
Are You a Good Fit for This Trial?
This trial is for individuals who are healthy or have symptoms of dementia, mild cognitive impairment, or Alzheimer's disease and related dementias. Participants will be involved in testing a new system that monitors walking patterns as potential biomarkers for cognitive decline.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-Lab Testing
Participants perform walking tasks and cognitive testing for several hours within a lab environment
In-Community Testing
Participants wear the insole and ankle device within their community for 1 week for collection of gait data in real world settings
Follow-up
Participants are monitored for safety and effectiveness after testing
What Are the Treatments Tested in This Trial?
Interventions
- Insole and Ankle Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
HealthPartners Institute
Lead Sponsor
National Institute on Aging (NIA)
Collaborator
Innovative Design Labs
Industry Sponsor