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

Trial Summary

What is the purpose of this trial?

Gait changes in Parkinson's disease are complex, variable, and difficult to detect during short clinic assessments. 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 provides vibrational feedback that can potentially help gait difficulties experienced by Parkinson's patients.

Research Team

Harini Sarva, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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 under 4 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 10 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+