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NCT06975059 | RECRUITING | Parkinson's Disease (PD)

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

Weill Medical College of Cornell University

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.

Condition or disease

Parkinson's Disease (PD)

Intervention/treatment

NUSHU shoe

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
Actual Study Start Date : 2025-05-30
Estimated Primary Completion Date : 2027-07
Estimated Study Completion Date : 2030-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Parkinson's Disease
  • Inclusion Criteria
    • 1. Male or female ≥ 18 years of age.
    • 2. A diagnosis of Parkinson's disease
    • 3. Able to give written informed consent (as determined by the investigator)
    • 4. Can converse in English and read and perform all study activities
    • 5. Has willingness and ability to comply with study requirements
    Exclusion Criteria
    • 1. Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD
    • 2. A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy
    • 3. Persons with disorders other than PD significantly affecting gait as determined by the investigator
    • 4. History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator
    • 5. Inability to wear interventional device
    • 6. Unable to ambulate independently at least with assistive walking device but without additional person assistance
    • 7. Pregnant or planning pregnancy within study timeframe
    • 8. Montreal Cognitive Assessment (MoCA) score \< 22 at screening
    • 9. Resides in a nursing home or assisted care facility
    • Healthy Controls
      • Inclusion Criteria
        • 1. Male or female ≥ 18 years of age.
        • 2. No neurological disease or other significant gait impairment as deemed by the study investigator
Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients

Location Details

NCT06975059

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Locations

RECRUITING

United States, New York

Weill Cornell

New York, New York, United States, 10021