[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591025":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":34,"centralContacts":38,"locations":46,"responsibleParty":64,"collaborators":33,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":33,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":33,"enrollmentInfo":76,"targetDuration":33,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":33,"overallStatus":49,"whyStopped":33,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Parkinson's Disease (Early)","EXPERIMENTAL","The early PD group will be those within 3 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.",[13],"Device: NUSHU shoe",{"label":15,"type":10,"description":16,"interventionNames":17},"Parkinson's Disease (Moderate)","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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Parkinson's Disease (Advanced)","The advanced PD group will be those with at least 8 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.",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Healthy Controls","ACTIVE_COMPARATOR","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.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[23,19,9,15],null,[35],{"name":36,"affiliation":5,"role":37},"Harini Sarva, MD","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":33,"email":42},"CONTACT","212-746-1685","has9059@med.cornell.edu",{"name":44,"role":40,"phone":33,"phoneExt":33,"email":45},"Clinical Research Coordinator","kyn4002@med.cornell.edu",[47],{"facility":48,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Weill Cornell","RECRUITING","New York","10021","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-74.00597,40.71427,{"lat":58,"lon":57},[61,63],{"name":62,"role":40,"phone":41,"phoneExt":33,"email":42},"Principal Investigator, MD",{"name":44,"role":40,"phone":41,"phoneExt":33,"email":45},{"type":65,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100591025","novel-shoe-device-nushu-to-measure-gait-analysis-in-parkinsons-patients-100591025",false,"NCT06975059","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","Parkinson's Disease:\n\nInclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. A diagnosis of Parkinson's disease\n3. Able to give written informed consent (as determined by the investigator)\n4. Can converse in English and read and perform all study activities\n5. Has willingness and ability to comply with study requirements\n\nExclusion Criteria:\n\n1. Diagnosis of an atypical parkinsonism syndrome, drug-induced parkinsonism, essential tremor, or other diagnoses that explain movement symptoms other than PD\n2. A diagnosis of significant CNS disease other than PD such as stroke, multiple sclerosis, epilepsy\n3. Persons with disorders other than PD significantly affecting gait as determined by the investigator\n4. History of MRI brain scan indicative of clinically significant abnormality as determined by the investigator\n5. Inability to wear interventional device\n6. Unable to ambulate independently at least with assistive walking device but without additional person assistance\n7. Pregnant or planning pregnancy within study timeframe\n8. Montreal Cognitive Assessment (MoCA) score \\\u003C 22 at screening\n9. Resides in a nursing home or assisted care facility\n\nHealthy Controls:\n\nInclusion Criteria:\n\n1. Male or female ≥ 18 years of age.\n2. No neurological disease or other significant gait impairment as deemed by the study investigator",true,"ALL","18 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.",[84],"Parkinson's Disease (PD)","2025-09-25",{"date":87,"type":88},"2025-10-01","ACTUAL",{"date":90,"type":88},"2025-05-30",{"date":92,"type":78},"2030-07",{"name":5,"class":6},1]