Nctid:
NCT06615310
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000003680", "term"=>"Deglutition Disorders"}, {"id"=>"D000020521", "term"=>"Stroke"}], "ancestors"=>[{"id"=>"D000002561", "term"=>"Cerebrovascular Disorders"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000004935", "term"=>"Esophageal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000010608", "term"=>"Pharyngeal Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M22306", "name"=>"Stroke", "asFound"=>"Stroke", "relevance"=>"HIGH"}, {"id"=>"M6882", "name"=>"Deglutition Disorders", "asFound"=>"Dysphagia", "relevance"=>"HIGH"}, {"id"=>"M5810", "name"=>"Cerebrovascular Disorders", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M8085", "name"=>"Esophageal Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M13515", "name"=>"Pharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>102}, "targetDuration"=>"1 Day", "patientRegistry"=>true}, "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"=>"muscle volume of thyrohyoid", "timeFrame"=>"baseline", "description"=>"the thickness of the muscle will be measured by ultrasound"}], "secondaryOutcomes"=>[{"measure"=>"muscle volume of sternohyoid", "timeFrame"=>"baseline", "description"=>"the thickness of the muscle will be measured by ultrasound"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Stroke", "Dysphagia"]}, "descriptionModule"=>{"briefSummary"=>"ultrasonographic parameters in stroke patients with dysphagia"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who have been diagnosed with stroke at Istanbul Physical Therapy and Rehabilitation Training and Research Hospital and enrolled in a rehabilitation program will be divided into 2 groups according to the presence of dysphagia (3 points and above according to the EAT-10 scale).", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria: Diagnosis of stroke,\n\n* Agreeing to participate in the study,\n* Cognitive competence to understand the test instructions\n* Communication skills to respond to the test instructions.\n\nExclusion Criteria:\n\n* Presence of a neurological disease other than stroke that will cause difficulty in swallowing, -Being illiterate,\n* refusing to participate in the study,\n* jaw joint problem,\n* surgical intervention in the neck area that will affect ultrasound measurements,\n* infected open wound"}, "identificationModule"=>{"nctId"=>"NCT06615310", "briefTitle"=>"Ultrasonographic Parameters in Stroke Patients With Dysphagia", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Istanbul Physical Medicine Rehabilitation Training and Research Hospital"}, "officialTitle"=>"The Relationship of Ultrasonographic Parameters Used in the Evaluation of Dysphagia in Stroke Patients With Swallowing Severity", "orgStudyIdInfo"=>{"id"=>"2024-41"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"dysphagia", "description"=>"3 Points and above according to the EAT-10 scale", "interventionNames"=>["Other: ultrasonograpic evaluotion"]}, {"label"=>"non-dysphagia", "description"=>"Under 3 points on the EAT-10 scale", "interventionNames"=>["Other: ultrasonograpic evaluotion"]}], "interventions"=>[{"name"=>"ultrasonograpic evaluotion", "type"=>"OTHER", "description"=>"The distance between the hyoid and thyroid cartilage, the volume of the geniohyoid, digastric anterior, sternohyoid and thyrohyoid muscles will be evaluated by ultrasound.", "armGroupLabels"=>["dysphagia", "non-dysphagia"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"associate proffesor", "role"=>"CONTACT", "email"=>"cansinmedin@hotmail.com", "phone"=>"800-555-5555"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Istanbul Physical Medicine Rehabilitation Training and Research Hospital", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"associate proffesor", "investigatorFullName"=>"Cansin Medin", "investigatorAffiliation"=>"Istanbul Physical Medicine Rehabilitation Training and Research Hospital"}}}}
