Nctid:
NCT06615297
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000020330", "term"=>"Bell Palsy"}, {"id"=>"D000005158", "term"=>"Facial Paralysis"}, {"id"=>"D000010243", "term"=>"Paralysis"}, {"id"=>"D000019066", "term"=>"Facies"}], "ancestors"=>[{"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000009059", "term"=>"Mouth Diseases"}, {"id"=>"D000009057", "term"=>"Stomatognathic Diseases"}, {"id"=>"D000006566", "term"=>"Herpesviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000005155", "term"=>"Facial Nerve Diseases"}, {"id"=>"D000003389", "term"=>"Cranial Nerve Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "relevance"=>"LOW"}, {"id"=>"M13157", "name"=>"Paralysis", "asFound"=>"Paralysis", "relevance"=>"HIGH"}, {"id"=>"M6882", "name"=>"Deglutition Disorders", "relevance"=>"LOW"}, {"id"=>"M22138", "name"=>"Bell Palsy", "asFound"=>"Facial Paralysis", "relevance"=>"HIGH"}, {"id"=>"M8301", "name"=>"Facial Paralysis", "asFound"=>"Facial Paralysis", "relevance"=>"HIGH"}, {"id"=>"M21089", "name"=>"Facies", "asFound"=>"Facial", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M9643", "name"=>"Herpesviridae Infections", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M8298", "name"=>"Facial Nerve Diseases", "relevance"=>"LOW"}, {"id"=>"M6605", "name"=>"Cranial Nerve Diseases", "relevance"=>"LOW"}, {"id"=>"T707", "name"=>"Bell's Palsy", "asFound"=>"Facial Paralysis", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"CROSS_SECTIONAL", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-04-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-09-13", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-03-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"facial nerve thickness", "timeFrame"=>"baseline", "description"=>"the thickness of the nerve will be measured by ultrasound"}], "secondaryOutcomes"=>[{"measure"=>"depressor labi inferior", "timeFrame"=>"baseline", "description"=>"the thickness of the muscle will be measured by ultrasound"}, {"measure"=>"depressor anguli oris", "timeFrame"=>"baseline", "description"=>"the thickness of the muscle will be measured by ultrasound"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Facial Paralysis, Central", "Stroke"]}, "descriptionModule"=>{"briefSummary"=>"70 stroke patients with central facial paralysis will be included and their demographic data will be questioned and facial nerve thickness, depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.", "detailedDescription"=>"70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included and their demographic data such as age, gender, marital status, education level, body mass index, stroke etiologies will be questioned and used with the House-Brackmann scale. Involvement levels, facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated. The data obtained will be correlated with total dysphagia score and facial disability index."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Diagnosis of stroke and presence of unilateral central facial paralysis,\n* Agreeing to participate in the study,\n* Cognitive competence to understand the test instructions,\n* Presence of communication skills to respond to the test instructions.\n\nExclusion Criteria:\n\n* Presence of previous facial paralysis or a neurological disease other than stroke that will cause central paralysis,\n* bilateral involvement\n* illiteracy, refusal to participate in the study,\n* jaw joint problem,\n* surgical intervention in the facial area that will affect ultrasound measurements,\n* infected open wound."}, "identificationModule"=>{"nctId"=>"NCT06615297", "briefTitle"=>"Mimic Muscle Volume, Central Facial Palsy Severity and Dysphagia", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Istanbul Physical Medicine Rehabilitation Training and Research Hospital"}, "officialTitle"=>"Demonstration of the Relationship Between Mimic Muscle Volume and Central Facial Palsy Severity and Dysphagia", "orgStudyIdInfo"=>{"id"=>"2024-40"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"central facial paralysis", "description"=>"70 stroke patients with central facial paralysis who were included in the rehabilitation program at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital will be included", "interventionNames"=>["Diagnostic Test: ultrasonographic evaluation"]}], "interventions"=>[{"name"=>"ultrasonographic evaluation", "type"=>"DIAGNOSTIC_TEST", "description"=>"facial nerve thickness (right/left), depressor labi inferior, depressor anguli oris, buccinator and risorius muscles will be evaluated.", "armGroupLabels"=>["central facial paralysis"]}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Istanbul Physical Medicine Rehabilitation Training and Research Hospital", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
