Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06975059

Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced Parkinson's Disease Patients and Healthy Controls

Led by Weill Medical College of Cornell University · Updated on 2025-10-01

40

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying gait changes in people with Parkinson's disease (PD), which can be complex and hard to detect during brief clinic visits. The study evaluates a novel shoe device called NUSHU by Magnes AG, designed to collect gait data and provide vibrational feedback that might help with walking difficulties experienced by PD patients. The trial includes adults diagnosed with early, moderate, or advanced PD, as well as healthy individuals without neurological diseases. Participants are grouped based on how long they have had PD: early (within 3 years), moderate (4-7 years), and advanced (8 or more years). Each group, including healthy controls, will attend four visits. During three of these visits, participants will wear the NUSHU shoes with and without vibrational feedback while in the clinic. The device uses sensors and machine learning to measure walking and provide feedback. During the study, participants will complete various assessments including walking tests and questionnaires to measure comfort, ease of use, and gait changes over 12 weeks. Researchers will monitor participants' satisfaction with the device, gait parameters like stride length and speed, and overall study completion rates over 18 weeks. The study aims to understand the device's impact and usability in people with different stages of Parkinson's disease and healthy controls.

CONDITIONS

Brief Title

Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Diagnosis of Parkinson's disease
  • Able to give written informed consent
  • Can read, speak English, and perform all study activities
  • Willing and able to comply with study requirements
  • Healthy controls must have no neurological disease or significant gait impairment
Not Eligible

You will not qualify if you...

  • Diagnosis of atypical parkinsonism, drug-induced parkinsonism, essential tremor, or other movement disorders besides Parkinson's disease
  • Significant central nervous system diseases other than Parkinson's disease, such as stroke, multiple sclerosis, or epilepsy
  • Other disorders significantly affecting gait as determined by the investigator
  • History of brain MRI showing clinically significant abnormalities
  • Unable to wear the study device
  • Cannot walk independently even with an assistive device without personal assistance
  • Pregnant or planning pregnancy during the study period
  • Montreal Cognitive Assessment score below 22 at screening
  • Living in a nursing home or assisted care facility

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 12 weeks

Participants wear the NUSHU shoe device during clinic visits to measure gait and receive vibrotactile feedback as a therapeutic intervention.

4 visits in total, with 3 visits involving wearing the shoes with and without vibration in clinic

Safety Follow-up

Duration - 6 weeks

Participants complete satisfaction surveys and safety assessments regarding the device after the intervention period.

1 visit (in-person) at Week 18

Trial Site Locations

Total: 1 location

1

Weill Cornell

New York, New York, United States, 10021

Actively Recruiting

Loading map...

Research Team

H

Harini Sarva, MD

C

Clinical Research Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

Similar Trials

Accelerated Transcranial Magnetic Stimulation Combined with ...

Parkinson's Disease (PD)

Actively Recruiting

1 location

Investigating the Role of Attention in Perceptual and Cognit...

Essential Tremor

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here