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

Weill Cornell Medicine (WCM)

Status: Begins enrollment this month

Conditions: Parkinson's Disease (PD)

Treatments: Device: NUSHU shoe

Study type: Interventional

Funder types: Other

Identifiers

NCT06975059

24-05027451

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Parkinson's Disease (Early)

Experimental group

Description:

The early PD group will be those under 4 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.

Treatment:

Device: NUSHU shoe

Parkinson's Disease (Moderate)

Experimental group

Description:

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.

Treatment:

Device: NUSHU shoe

Parkinson's Disease (Advanced)

Experimental group

Description:

The advanced PD group will be those with at least 10 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.

Treatment:

Device: NUSHU shoe

Healthy Controls

Active Comparator group

Description:

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.

Treatment:

Device: NUSHU shoe