NUSHU Shoe Device for Parkinson's Disease

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Atypical parkinsonism, Stroke, Epilepsy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new shoe device called NUSHU, designed to help people with Parkinson's disease manage walking difficulties. The shoe contains sensors to measure walking patterns and provides vibrations that might improve gait problems. Researchers aim to determine the effectiveness of these shoes for individuals at different stages of Parkinson's. Those diagnosed with Parkinson's for at least three years, or individuals without neurological issues who can walk independently, may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility for Parkinson's patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the NUSHU shoe device is safe for Parkinson's patients?

Research has shown that the NUSHU shoe device is safe for use. The FDA has registered it as a Class 2 device, indicating it is safe for its intended purpose, with sufficient evidence supporting its safety.

Designed to assist people with Parkinson's disease, the shoe uses vibrations to enhance walking and collects data on gait. Studies have not reported any major negative effects from using NUSHU. Overall, the device is well-tolerated and approved for use in both the US and Europe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NUSHU Shoe Device is unique because it offers a non-invasive approach to managing Parkinson's Disease symptoms through a new delivery method: vibration therapy integrated into footwear. Unlike traditional medications that primarily focus on dopamine replacement or modulation, this device aims to enhance mobility and gait by directly stimulating the feet. Researchers are excited about this treatment because it could provide a complementary or alternative option to existing pharmacological treatments, potentially reducing the reliance on drugs and their associated side effects. Additionally, its use across different stages of Parkinson's, from early to advanced, highlights its versatility and potential to improve quality of life for a wide range of patients.

What evidence suggests that the NUSHU shoe device is effective for Parkinson's disease?

Research shows that the NUSHU shoe device can assist people with Parkinson's disease who have difficulty walking. In this trial, participants with early, moderate, and advanced Parkinson's disease, along with healthy controls, will test the NUSHU shoes. Studies have found that these shoes use smart sensors to gather detailed information about walking patterns, aiding in understanding and tracking movement changes. The NUSHU shoes also provide gentle vibrations, which may help correct walking patterns. This technology offers a new way to manage symptoms between doctor visits, potentially improving daily life for those with Parkinson's. ^{1 2 3 6 7}

Who Is on the Research Team?

Harini Sarva, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who experience gait changes. The study involves using a novel shoe device, NUSHU, which has built-in sensors to measure walking patterns and provides vibrational feedback.

Inclusion Criteria

Can converse in English and read and perform all study activities

Has willingness and ability to comply with study requirements

No neurological disease or other significant gait impairment as deemed by the study investigator

Exclusion Criteria

Resides in a nursing home or assisted care facility

History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator

Inability to wear interventional device

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the NUSHU shoe device for gait analysis and vibrational feedback over 4 visits

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NUSHU

Trial Overview The NUSHU shoe by Magnes AG is being tested to see if it can accurately measure gait in Parkinson's patients and improve their walking difficulties through vibrational feedback.

How Is the Trial Designed?

Group I: Parkinson's Disease (Moderate) Experimental Treatment 1 Intervention

The moderate PD group will be those with 4-7 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.

Group II: Parkinson's Disease (Early) Experimental Treatment 1 Intervention

The early PD group will be those within 3 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.

Group III: Parkinson's Disease (Advanced) Experimental Treatment 1 Intervention

The advanced PD group will be those with at least 8 years of diagnosis. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.

Group IV: Healthy Controls Active Control 1 Intervention

Healthy controls will include those without any neurological disease or other significant gait impairment. Each group will be administered the same administration of 4 visits, with 3 of the visits wearing the shoes with and without vibration in clinic.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06975059

Novel Shoe Device NUSHU to Measure Gait Analysis ... The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8074136/

An Intelligent In-Shoe System for Gait Monitoring and ... To perform gait analysis, a pair of motion sensing shoes called Nushu is developed in this study for data acquisition. ... Parkinson's disease and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700807/

Commercial symptom monitoring devices in Parkinson's ... Specifically designed to assess PD, these devices offer a new approach by providing quantitative data on motor symptoms outside traditional ...

4. withpower.com withpower.com/trial/nushu-shoe-device-for-parkinsons-disease-b3553

NUSHU Shoe Device for Parkinson's Disease The aim of this study is to collect gait measurements in Parkinson's patients through sensors in a novel shoe device, NUSHU by Magnes AG. The shoe additionally ...

5. magnes.ch magnes.ch/solutions/nushu/

Nushu - Magnes AG Magnes' innovative smart sensors in shoes monitor gait in neurological disorders, providing AI-generated feedback. Improves efficacy in clinical trials ...

6. app.trialscreen.org app.trialscreen.org/trials/novel-shoe-device-nushu-to-measure-gait-analysis-parkinson-s-patients-trial-nct06975059

Novel Shoe Device NUSHU to Measure Gait Analysis ... Gait Monitoring in Parkinson's with NUSHU Shoe. Evaluating a Novel Shoe Device for Gait Analysis and Feedback in Parkinson's Patients.

7. parkinsonsnewstoday.com parkinsonsnewstoday.com/news/smart-shoes-magnes-ease-parkinsons-gait-available-eu-us/

Smart shoes by Magnes to ease Parkinson's gait cleared in ... NUSHU, a sneaker-like shoe, has sensors for real-time feedback to assist walking and to collect for analysis of gait issues.