Novel Shoe Device NUSHU to Measure Gait Analysis in Parkinson's Patients
Recruiting · NCT06975059 · Interventional (participants receive a specific treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
NUSHU shoe
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Weill Cornell - New York, New York, United States