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

NCT06975059 | Recruiting

• 1 other identifier: 24-05027451
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (3)

• Mean Score of Comfort Level of Device in Satisfaction Survey

  The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How would you rate the comfort level of the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning most uncomfortable and 5 meaning most comfortable. Mean score for each individual question will be provided.

  At Safety Follow Up (Week 18)

• Mean Score of Ease of Using Device in Satisfaction Survey

  The satisfaction survey contains 2 demographic questions and 5 questions about participant satisfaction completed at end of study participation. The comfort level of the device question is the following: How easy was it to use the device? The scale is 0, 1, 2, 3, 4, 5, with 0 meaning very easy and 5 meaning very difficult. Mean score for each individual question will be provided.

  At Safety Follow Up (Week 18)

• Ratio of Participants Who Completed Study to Total Number of Participants Enrolled

  We would like to measure the retention rate to assess feasibility. The lowest ratio would be 0, and the highest ratio would be 1.

  Through study completion, 18 weeks

Secondary Outcomes (11)

• Mean Change from Baseline to Week 12 in TUG test

  At Baseline and In 12 Weeks

• Mean Change from Baseline to Week 12 in FOG Questionnaire

  At Baseline and In 12 Weeks

• Mean Change from Baseline to Week 12 in MDS-UPDRS III

  At Baseline and In 12 Weeks

• Mean Change from Baseline to Week 12 in Stride Time

  At Baseline and In 12 Weeks

• Mean Change from Baseline to Week 12 in Stride Length

  At Baseline and In 12 Weeks

Study Arms (4)

Parkinson's Disease (Early)

EXPERIMENTAL

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.

Device: NUSHU shoe

Parkinson's Disease (Moderate)

EXPERIMENTAL

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.

Device: NUSHU shoe

Parkinson's Disease (Advanced)

EXPERIMENTAL

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.

Device: NUSHU shoe

Healthy Controls

ACTIVE COMPARATOR

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.

Device: NUSHU shoe

Interventions

NUSHU shoe DEVICE

The NUSHU shoe, created by Magnes AG, can measure real-time detection of gait analysis while providing vibrotactile stimulus to the study participant through machine learning sensors. This may provide a feedback mechanism that acts as therapy for gait difficulties.

Healthy Controls; Parkinson's Disease (Advanced); Parkinson's Disease (Early); Parkinson's Disease (Moderate)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• A diagnosis of Parkinson's disease
• Able to give written informed consent (as determined by the investigator)
• Can converse in English and read and perform all study activities
• Has willingness and ability to comply with study requirements

You may not qualify if:

• Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
• A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
• Persons with disorders other than PD significantly affecting gait as determined by the investigator
• History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
• Inability to wear interventional device
• Unable to ambulate independently at least with assistive walking device but without additional person assistance
• Pregnant or planning pregnancy within study timeframe
• Montreal Cognitive Assessment (MoCA) score \< 22 at screening
• Resides in a nursing home or assisted care facility
• Healthy Controls:
• Male or female ≥ 18 years of age.
• No neurological disease or other significant gait impairment as deemed by the study investigator

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell

New York, New York, 10021, United States

RECRUITING

Study Officials

• Harini Sarva, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harini Sarva, MD

CONTACT

212-746-1685; has9059@med.cornell.edu

Clinical Research Coordinator

CONTACT

kyn4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)