Smartshoes for Parkinson's Disease

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Peripheral neuropathy, Orthotics, Dementia, others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests smart shoes designed to help people with Parkinson's disease, particularly those experiencing freezing of gait (when feet feel stuck to the ground). The shoes send vibrations to the feet to determine if they can improve walking. Participants will perform walking tasks with and without these vibrations to assess the shoes' safety and effectiveness. Individuals with Parkinson's, whether or not they experience freezing episodes, and healthy individuals who can walk for 10 minutes, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance mobility for those with Parkinson's.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your Parkinson's medication, as the trial includes participants in the 'ON phase' of their medication.

What prior data suggests that these Smartshoes are safe for Parkinson's disease patients and healthy controls?

Research shows that smartshoes, which use gentle vibrations, are generally well-received by people with Parkinson's disease. The FDA has approved these smartshoes, indicating their safety. Previous studies found that these shoes can help people with Parkinson's walk more safely and independently. Although specific side effects aren't mentioned in the sources, the emphasis on improving walking suggests the shoes are designed to be comfortable and safe. For those considering joining the trial, it's reassuring that smartshoes have shown promise in other studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these smartshoes because they offer a new way to help people with Parkinson's disease manage their symptoms, particularly freezing episodes. Unlike traditional treatments, such as medication or physical therapy, these shoes provide vibrotactile feedback—a kind of gentle vibration—to guide walking rhythm and improve movement. This method is non-invasive and could be personalized to match each person's natural walking speed, potentially making everyday activities easier and safer for those affected by Parkinson's.

What evidence suggests that Smartshoes are effective for treating freezing of gait in Parkinson's disease?

Research has shown that wearable devices, like smartshoes, can help manage symptoms of Parkinson's disease. About 29% of studies have focused on the use of smartshoes for Parkinson's. In this trial, participants will be divided into groups, including those with Parkinson's disease with and without freezing episodes, as well as healthy controls. These devices provide feedback that can improve walking. By giving gentle vibrations, smartshoes may help prevent feet from feeling stuck to the ground, a symptom known as freezing of gait. This technology supports better movement in everyday life. Early evidence suggests that smartshoes could be a promising tool for people with Parkinson's. ^{2 6 7 8 9}

Who Is on the Research Team?

Hengameh Zahed, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience freezing of gait (FOG). Participants should be able to walk at least 10 feet independently and have a stable medication regimen. People with implanted medical devices affecting movement or those unable to follow study procedures are excluded.

Inclusion Criteria

I have Parkinson's disease, experience freezing of gait, and am in stages 2 to 3.

I have Parkinson's disease, stage 2 to 3, and don't experience freezing of gait.

I am between 40-80 years old, can walk for 10 minutes, consent to participate, and read/write English at an 8th grade level.

Exclusion Criteria

For all participants (PD with or without freezing, or age-matched controls): moderate to severe peripheral neuropathy (based on self report or clinical exam using vibration tuning fork) which may limit ability to sense the vibratory feedback, use of orthotics incompatible with the haptic wearable shoes, severe balance deficits or daily falls at baseline, patients with dementia (MoCA<18) who are not able to appropriately provide consent for the study, pregnant persons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform 3 walking tasks with and without vibrotactile feedback to evaluate the safety and tolerability of the smartshoes

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartshoes

Trial Overview The study tests smartshoes equipped with haptic vibration feedback designed to help manage FOG in Parkinson's patients. It's a pilot study, meaning it's an early-stage trial to assess the safety and potential usefulness of these shoes before larger trials.

How Is the Trial Designed?

Group I: Parkinson's disease without freezing episodes Experimental Treatment 1 Intervention

Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.

Group II: Parkinson's disease with freezing episodes Experimental Treatment 1 Intervention

Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.

Group III: Healthy Controls Experimental Treatment 1 Intervention

Participants perform 3 walking tasks in random order: 1 with receiving vibrotactile feedback in swing-phase of gait, 1 with receiving vibrotactile feedback in metronome (regularly timed) vibration (set at low/medium/fast based on preferred/natural walking speed of the patient at baseline), and another with no vibration.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10770131/

Machine Learning in the Parkinson's disease smartwatch ... The dataset includes all 469 individual assessments and detailed descriptions on how to work with the data.

2. nature.com nature.com/articles/s41531-024-00721-2

Using a smartwatch and smartphone to assess early ... Digital measures may provide objective, sensitive, real-world measures of disease progression in Parkinson's disease (PD).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11137004/

Digital outcome measures from smartwatch data relate to ... Monitoring of Parkinson's disease (PD) has seen substantial improvement over recent years as digital sensors enable a passive and continuous ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0957417423010436

Deep learning and wearable sensors for the diagnosis and ... This paper provides the reader with a summary of the current applications of DL and wearable devices for the diagnosis, prognosis, and monitoring of PD.

5. mdpi.com mdpi.com/2076-3417/7/10/986

An Overview of Smart Shoes in the Internet of Health Things In their study, the authors found that 29% of the included articles address Parkinson's disease, 17% Cerebral Palsy, and 13% orthoses, as summarized in Figure 6 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07001072

Smartshoes for Freezing of Gait in Parkinson's Disease This is a pilot research study aimed at evaluating whether an FDA listed wearable shoe with capability to deliver vibration feedback can be safe and tolerable ...

7. ieeexplore.ieee.org ieeexplore.ieee.org/document/10550344/

Smart Shoe Technology: Empowering Parkinson's Patients ... The Smart Shoe is a wearable gadget that combines several technologies to improve safety and independence for individuals with Parkinson's disease.

8. withpower.com withpower.com/trial/phase-parkinson-disease-8-2025-45d28

Smartshoes for Parkinson's Disease · Info for Participants This is a pilot research study aimed at evaluating whether an FDA listed wearable shoe with capability to deliver vibration feedback can be safe and ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352648322000721

Closed-looped sensing and stimulation system for ... Along with pressure sensors embedded in smart shoes, Zhang et al. have used data from inertial sensors to monitor the abnormal motion of PD patients [31]. Show ...