[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555991":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":29,"locations":38,"responsibleParty":60,"collaborators":62,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":10,"enrollmentInfo":89,"targetDuration":92,"studyType":93,"phases":10,"briefSummary":94,"conditions":95,"keywords":10,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Freezing Of Gait Patients",null,"15 patients with Parkinson disease with freezing of gait (group) in ON \\& OFF states",[13,14],"Device: Opals","Device: Axivity",{"label":16,"type":10,"description":17,"interventionNames":18},"Non Freezing Of Gait Patients","5 patients with Parkinson disease without freezing of gait (cohort) in ON \\& OFF states",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Opals","Five Oplas sensors were strategically placed on participants: one on each shin, one on each foot, and one on the lower back.",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Axivity","At the end of the first session, participants with FOG, will be fitted with an Axivity monitor. This is wearable sensor that will be attached to the participant's lower back (lumbar vertebrae 4-5) with hypoallergic medical tape by the researcher, and will be worn continuously for seven days.\n\nThe Axivity monitor is a small (23 x 32.5 x 8.9 mm) and lightweight (11g) device that measures mobility via a tri-axial accelerometer and gyroscope and stores this data onboard, no GPS or other localization options are possible with this monitor. Participants will be given following guidelines concerning the use:\n\nThe sensor is to be worn continuously during the seven-day period, i.e. also while sleeping and showering.\n\nThe sensor is waterproof and can be worn during showering.",[9,16],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Omri Batori, B.sc","CONTACT","+972546670256","omrib@tlvmc.gov.il",{"name":36,"role":32,"phone":10,"phoneExt":10,"email":37},"Jeffery Hausdorff, Professor","jeffh@tlvmc.gov.il",[39],{"facility":40,"status":41,"city":42,"state":10,"zip":10,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Tel Aviv Saurasky Medical Center","RECRUITING","Tel Aviv","Israel","IL",{"type":46,"coordinates":47},"Point",[48,49],34.78057,32.08088,{"lat":49,"lon":48},[52,54,58],{"name":53,"role":32,"phone":33,"phoneExt":10,"email":34},"omri Batori, B.sc",{"name":55,"role":32,"phone":56,"phoneExt":10,"email":57},"Shahar Siman Toc, B.sc","+972526736689","shaharst@tlvmc.gov.il",{"name":59,"role":32,"phone":10,"phoneExt":10,"email":10},"Jeffery Hausdorff, Proffesor",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[63,66,68,70,73,75,77],{"name":64,"class":65},"KU Leuven","OTHER",{"name":67,"class":65},"Oregon Health and Science University",{"name":69,"class":65},"University of Sydney",{"name":71,"class":72},"Radbound University Medical Center","UNKNOWN",{"name":74,"class":65},"University of Waterloo",{"name":76,"class":65},"Emory University",{"name":78,"class":65},"University of Rochester","100555991","freezing-of-gait---clinical-outcomes-assessment-100555991",false,"NCT06519279","Freezing of Gait - Clinical Outcomes Assessment","An International Multimodal Protocol for Assessing Freezing of Gait in Individuals Living with Parkinson's Disease","FOG-COA","Inclusion Criteria:\n\n1. Diagnosis of idiopathic Parkinson's disease (PD) made by a neurologist according to the Movement Disorders Society guidelines;\n2. Able to walk independently for a distance of 10 meters, without walking aid;\n3. Absence of a Deep Brain Stimulator;\n4. Stable PD treatment in the 4 weeks prior to participation that is not expected to change in the course of the study.\n5. For patients with FOG: a score of ≥ 1 on the New Freezing Of Gait Questionnaire (NFOG-Q).\n\nExclusion Criteria:\n\n1. Occurrence of any of the following within 3 months prior to informed consent: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD), active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class \\>3), acute psychosis or major psychiatric disorders or continued substance abuse, other neurological (than PD) or orthopaedic impairment that significantly impacts on gait.\n2. Unwilling to temporarily delay the morning anti-Parkinsonian medication.\n3. Preganacy and","ALL","18 Years",{"count":90,"type":91},20,"ESTIMATED","1 Month","OBSERVATIONAL","To develop a reliable and accurate clinician-reported outcome (ClinRO) measure (against a new and precise definition) and patient reported outcome (PRO) for use by clinicians and researchers to quantify the severity of Freezing of Gait (FOG).",[96],"PD - Parkinson's Disease","2025-01-23",{"date":99,"type":100},"2025-01-28","ACTUAL",{"date":102,"type":100},"2024-10-01",{"date":104,"type":91},"2025-12",{"name":5,"class":6},1]