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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About 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.

Who May Be Eligible (Plain English)

Parkinson's Disease: Who May Qualify: 1. Male or female ≥ 18 years of age. 2. A diagnosis of Parkinson's disease 3. Able to give written willing to sign a consent form (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 Who Should NOT Join This Trial: 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: Who May Qualify: 1. Male or female ≥ 18 years of age. 2. No neurological disease or other significant gait impairment as deemed by the study investigator Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

Weill Cornell
New York, New York, United States