Clinical trial NCT06975059: Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients
Official title: Using the NUSHU Shoe to Analyze Gait Balance and Vibrotactile Feedback in Early, Moderate and Advanced PD Patients and Healthy Controls
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson&#39;s Disease (PD)
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean Score of Comfort Level of Device in Satisfaction Survey
timeFrame: At Safety Follow Up (Week 18)
measure: Mean Score of Ease of Using Device in Satisfaction Survey
timeFrame: At Safety Follow Up (Week 18)
measure: Ratio of Participants Who Completed Study to Total Number of Participants Enrolled
timeFrame: Through study completion, 18 weeks
Secondary outcomes:
measure: Mean Change from Baseline to Week 12 in TUG test
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in FOG Questionnaire
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in MDS-UPDRS III
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Stride Time
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Stride Length
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Swing Time
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Stance Time
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Velocity
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Cadence
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Swing Phase
timeFrame: At Baseline and In 12 Weeks
measure: Mean Change from Baseline to Week 12 in Stance Phase
timeFrame: At Baseline and In 12 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Harini Sarva, MD
role: PRINCIPAL_INVESTIGATOR
References: