Insole and Ankle Device for Dementia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Non-English speaking, Ankle-foot orthosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

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. ^{1 2 3 4 5}

Why 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. ^{1 3 6 7 8}

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

I am 55 years old or older.

I can walk without any help from devices like canes or walkers.

I can put on and take off the study device by myself or have someone to help me.

Exclusion Criteria

Any other significant medical condition that may affect participation or performance in the study, as determined by investigators

I have had a blood clot in my vein recently.

I have untreated fractures in my foot or ankle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-Lab Testing

Participants perform walking tasks and cognitive testing for several hours within a lab environment

1 day

1 visit (in-person)

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

1 week

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Insole and Ankle Device

Trial Overview The study tests an insole and ankle device designed to collect gait data. It includes two parts: one where participants perform tasks in a lab setting, and another where they wear the devices at home and community settings for a week.

How Is the Trial Designed?

Group I: Individuals using the insole and ankle device Experimental Treatment 1 Intervention

Participants will use the wearable leg module and insole device for either several hours in a lab environment or 1 week within their home and the community. Data will be recorded by the device

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Innovative Design Labs

Industry Sponsor

Trials

3

Recruited

230+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07127133

Study Details | NCT07127133 | An Insole and Ankle Device ... This study will be performed in two parts and involves collecting gait data from participants using the leg module and insole device either (1) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5822856/

The effect of flat and textured insoles on the balance of ... The results suggest that foot orthoses (both flat and textured insoles) are effective in improving balance in primary care elderly people.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0958259220301061

Review Immediate effect of insoles on balance in older adults This meta-analysis provides evidence that insoles improve standing balance and gait performance in older adults as soon as they are applied.

4. science.org science.org/doi/10.1126/sciadv.adu1598

A wireless, self-powered smart insole for gait monitoring ... We report a fully integrated, self-powered, wireless smart insole designed for plantar pressure monitoring and real-time visualization and analysis of gait.

5. mdpi.com mdpi.com/1424-8220/24/21/7059

Wearable Technology Applications and Methods to Assess ... This article highlights recent achievements and developments in wearable sensor-based foot and ankle clinical assessment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11548473/

Wearable Technology Applications and Methods to Assess ... This article highlights recent achievements and developments in wearable sensor-based foot and ankle clinical assessment.

7. mdpi.com mdpi.com/2079-6374/13/8/833

Insole Systems for Disease Diagnosis and Rehabilitation Nowadays, various insole systems based on different sensing techniques have been developed to monitor gait and aid in medical research. Hence, a detailed review ...

8. news-medical.net news-medical.net/news/20250417/Smart-insoles-offer-real-time-gait-tracking-and-early-health-warnings.aspx

Smart insoles offer real time gait tracking and early health ... According to the study, these smart insoles showed no notable deterioration in performance after 180,000 cycles of compression and decompression ...