[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608420":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":12,"collaborators":7,"id":16,"slug":17,"hasResults":18,"nctId":19,"briefTitle":20,"officialTitle":21,"acronym":7,"eligibilityCriteria":22,"healthyVolunteers":18,"sex":23,"minAge":24,"maxAge":25,"enrollmentInfo":26,"targetDuration":29,"studyType":30,"phases":7,"briefSummary":31,"conditions":32,"keywords":35,"overallStatus":41,"whyStopped":7,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":7},{"fullName":5,"class":6},"Wroclaw University of Health and Sport Sciences","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"cranial helmet therapy - observational","This observational study involves children undergoing cranial helmet therapy. The intervention is not assigned by the investigator. Repeated measurements are performed within participants to evaluate therapy effects. Stage 1 assesses head shape changes to analyze therapy effectiveness. Stage 2 examines factors influencing effectiveness, considering age, deformity type, and sex.\n\nStage 3 measures body surface temperature using thermal imaging before, during, and after helmet use, with participants analyzed in three age groups: 4-6, 7-9, and 10-12 months. Stage 4 evaluates cervical spine rotation before therapy and after completion, with participants analyzed in the same three age groups.",{"type":13,"investigatorFullName":14,"investigatorTitle":15,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Natalia Zielińska","Master of Physiotherapy","100608420","effects-of-corrective-helmet-therapy-on-cervical-motion-and-thermoregulation-in-children-with-positional-deformities-100608420",false,"NCT07201324","Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities","Analysis of the Relationships Between Cranial Remolding Orthosis Therapy, Cervical Spine Motor Function, and Thermoregulatory Responses in Children With Cranial Deformity","Inclusion Criteria:\n\n* positional head deformity of severe or very severe degree;\n* age at therapy initiation: 4-12 months;\n* minimum therapy duration of 12 weeks (for Stage 1 and Stage 2).\n\nExclusion Criteria:\n\n* craniosynostosis;\n* hydrocephalus;\n* non-adherence to 23-hour daily helmet use;\n* metabolic disorders;\n* torticollis.","ALL","4 Months","12 Months",{"count":27,"type":28},270,"ESTIMATED","6 Months","OBSERVATIONAL","The purpose of the study is to examine how cranial helmet therapy may affect neck movement and body temperature regulation in children with positional head deformity. The study will also look at factors that might influence how well the therapy works, such as the child's age, sex, and the type of head shape deformity.\n\nDuring the study, children will undergo several assessments:\n\nmeasurement of head shape using standard cranial indices, recording of body surface temperature with a thermal imaging camera, evaluation of neck mobility, focusing on rotation of the cervical spine.",[33,34],"Plagiocephaly, Nonsynostotic","Brachycephaly",[36,37,38,39,40],"positional head deformity","helmet therapy","infants","thermoregulation","range of motion of the cervical spine","NOT_YET_RECRUITING","2025-09-23",{"date":44,"type":45},"2025-10-01","ACTUAL",{"date":47,"type":28},"2025-09",{"date":49,"type":28},"2027-05",{"name":5,"class":6}]