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Recruiting NCT06975059

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

No phase Interventional Parkinson's Disease (PD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NUSHU shoe.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls

Overview

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.

Interventions

  • Device NUSHU shoe
    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.

Primary outcome measures

  • Mean Score of Comfort Level of Device in Satisfaction Survey [Time frame: At Safety Follow Up (Week 18)]
  • Mean Score of Ease of Using Device in Satisfaction Survey [Time frame: At Safety Follow Up (Week 18)]
  • Ratio of Participants Who Completed Study to Total Number of Participants Enrolled [Time frame: Through study completion, 18 weeks]
Secondary outcome measures (11)
  • Mean Change from Baseline to Week 12 in TUG test [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in FOG Questionnaire [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in MDS-UPDRS III [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stride Time [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stride Length [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Swing Time [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stance Time [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Velocity [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Cadence [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Swing Phase [Time frame: At Baseline and In 12 Weeks]
  • Mean Change from Baseline to Week 12 in Stance Phase [Time frame: At Baseline and In 12 Weeks]

Eligibility criteria

Parkinson's Disease:

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell — New York

Identifiers

NCT: NCT06975059 · 24-05027451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗