Status:

RECRUITING

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

Lead Sponsor:

Weill Medical College of Cornell University

Conditions:

Parkinson's Disease (PD)

Eligibility:

All Genders

18+ years

Phase:

NA

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 throug...

Eligibility Criteria

Inclusion

  • Parkinson's Disease:
  • 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

Exclusion

  • 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:
  • Inclusion Criteria:
  • Male or female ≥ 18 years of age.
  • No neurological disease or other significant gait impairment as deemed by the study investigator

Key Trial Info

Start Date :

May 30 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2030

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06975059

Start Date

May 30 2025

End Date

July 1 2030

Last Update

October 1 2025

Active Locations (1)

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1

Weill Cornell

New York, New York, United States, 10021