[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571631":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":25,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":10,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Responder group",null,"Patients with iNPH were divided into responder group and non-responder group after CSF tap test.\n\nThe responder group consists of patients who underwent the tap test and exhibited improvements in gait and balance, including increased gait speed as measured by the 10-Meter Walk Test (10MWT), reduced time on the Timed Up and Go Test (TUGT), and resolution of shuffling, magnetic, and wide-based gait patterns. Classification were done by a multidisciplinary team including physiatrist, neurologist, and neurosurgeon.\n\nSurgical treatment was carefully considered for the responder group. Patients who declined surgery or were considered at high risk for surgical complications due to advanced age or comorbidities were excluded. Patients who were able to get an operation primarily underwent shunt surgery.\n\nAdditional gait and balance analyses were performed on patients who underwent surgery within 24 hours after their last operation.",{"label":13,"type":10,"description":14,"interventionNames":10},"Non-Responder group","Patients with iNPH were divided into responder group and non-responder group after CSF tap test.\n\nThe non-responder group consists of patients who underwent the tap test but did not exhibit improvements in gait or balance. Classification were done by a multidisciplinary team including physiatrist, neurologist, and neurosurgeon.\n\nSurgical treatment was not considered for the responder group.",[16,21],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"Na Young Kim, MD, PhD","CONTACT","+82 010 9127 4482","kny8452@yuhs.ac",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Seung Ick Choi","+82 010 8821 5297","rehab1@yuhs.ac",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":10,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Yongin Severance Hospital","RECRUITING","Yongin-si","Gyeonggi-do","16995","South Korea",{"type":34,"coordinates":35},"Point",[36,37],127.08042,37.29686,{"lat":37,"lon":36},[40,41,42],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},{"name":17,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100571631","identifying-gait-changes-from-a-csf-tap-test-using-a-smart-insole-in-inph-100571631",false,"NCT06722768","Identifying Gait Changes From a CSF Tap Test Using a Smart Insole in iNPH","Identifying Gait Changes From a Cerebrospinal Fluid Tap Test Using a Smart Insole in Idiopathic Normal Pressure Hydrocephalus","Inclusion Criteria:\n\n* individuals who have more than 1 symptom in the clinical triad including gradually developed gait disturbances mainly showing shuffling, magnetic, wide based gait\n* individuals who assessed a standardized cranial MRI scan and those with an Evans ratio greater than 0.30 were included in the study (Microvascular lesions in the white matter were accepted only if they were mild.)\n* individuals who voluntarily agree to participate in the study and sign a consent form\n\nExclusion Criteria:\n\n* individuals with history of hemorrhage\n* individuals unable to walk independently on flat ground for 10 meters\n* individuals with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, or endocrine systems\n* individuals considered clinically unsuitable for the trial by the trial manager or person in charge based on significant medical findings","ALL",{"count":55,"type":56},50,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to to evaluate various gait parameters by a sensor-embedded smart insole before and after the cerebrospinal fluid (CSF) tap test in idiopathic normal pressure hydrocephalus (iNPH) patients.\n\nThe main questions it aims to answer are:\n\n* Does the CSF tap test enhance gait and balance parameters in participants?\n* Does the CSF tap test enhance cognitive and urinary symptoms in participants?\n\nResearchers will compare pre- and post-CSF tap test gait and balance parameters by a sensor-embedded smart insole.\n\nParticipants will:\n\n* Participate in physical function assessments including the 10-meter walk test, Timed Up and Go test, and Berg Balance Scale wearing sensor-embedded smart insoles before and after the CSF tap test.\n* Complete survey about cognitive and unary symptoms before and after the CSF tap test.",[60],"Normal Pressure Hydrocephalus",[62,63,64],"gait analysis","smart insole","Cerebrospinal fluid tap test","2024-12-03",{"date":67,"type":68},"2024-12-09","ACTUAL",{"date":70,"type":68},"2021-06-01",{"date":72,"type":56},"2025-02",{"name":5,"class":6},1]