[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brachycephaly\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brachycephaly":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,89,110],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"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":20,"type":21},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.",[26,27],"Plagiocephaly, Nonsynostotic","Brachycephaly",[29,30,31,32,33],"positional head deformity","helmet therapy","infants","thermoregulation","range of motion of the cervical spine","NOT_YET_RECRUITING","2025-09-23",{"date":37,"type":38},"2025-10-01","ACTUAL",{"date":40,"type":21},"2025-09",{"date":42,"type":21},"2027-05",{"name":44,"class":45},"Wroclaw University of Health and Sport Sciences","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100509764","effectiveness-of-repositioning-and-cranial-remolding-in-infants-with-cranial-deformation-100509764","NCT05917678","Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation","Effectiveness of Repositioning, Physical Therapy, and Cranial Remolding in Infants With Cranial Deformation","Inclusion Criteria for Control Group:\n\n* Healthy infants with normal physical development and no need for physical therapy intervention\n\nExclusion Criteria for Control Group:\n\n* Infants with abnormal head shapes (plagiocephaly or craniosynostosis)\n* Infants with growth abnormalities (such as genetic conditions)\n* Infants with developmental delay significant to warrant physical therapy or occupational therapy",true,"2 Months","3 Months",{"count":57,"type":21},65,"INTERVENTIONAL",[60],"NA","This study will examine how effective caregiver's repositioning strategies are in correcting an infant's deformational cranial shape, as well as the effectiveness of the use of a custom cranial remolding orthosis for treatment of deformational head shapes. Infants with torticollis will be concurrently enrolled in physical therapy treatment until the torticollis is resolved. A normal, unaffected population will be studied to compare typical growth to the growth of infants undergoing active treatment.",[63,64,27,65,66],"Deformational Plagiocephaly","Deformational Posterior Plagiocephaly","Torticollis","Congenital Muscular Torticollis",[68,69,70,71,72,73,74,75,76,77],"plagiocephaly","brachycephaly","asymmetrical brachycephaly","helmet","cranial remolding","orthosis","repositioning","deformational","torticollis","normal","RECRUITING","2025-08-21",{"date":81,"type":38},"2025-08-28",{"date":83,"type":38},"2023-05-23",{"date":85,"type":21},"2026-07-01",{"name":87,"class":45},"University of Texas Southwestern Medical Center",1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":88},"100548759","monitoring-system-for-cranial-orthoses-100548759","NCT06425172","Monitoring System for Cranial Orthoses","A Monitoring System for Cranial Remolding Orthoses","Inclusion Criteria:\n\n* Infants who are clinically indicated for cranial remolding orthoses for treatment of a deformational head shape (i.e. plagiocephaly \u002F brachycephaly)\n\nExclusion Criteria:\n\n* non-English speaking caregivers\n* infants with craniosynostosis or those not indicated for cranial remolding\n* infants with developmental comorbidities which affect cranial growth","18 Months",{"count":98,"type":21},12,"This is a study which investigates the wear time and fit of a cranial remolding orthosis (a standard-of-care treatment where an infant wears a custom helmet to help reshape their head as they grow).",[101,27,63,64],"Plagiocephaly","2025-07-01",{"date":104,"type":38},"2025-07-03",{"date":106,"type":38},"2024-08-19",{"date":108,"type":21},"2026-06-01",{"name":87,"class":45},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":116,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":88},"100574700","cranial-remolding-orthosis-registry-100574700","NCT06762691","Cranial Remolding Orthosis Registry","Inclusion Criteria:\n\n* Patient has been evaluated and successfully scanned for a MyCRO Band or similar CRO\n* Patient's parent(s) or legal guardian(s) are able to communicate, provide feedback, understand and follow instructions during the course of the registry.\n* Parent(s) or legal guardian(s) are willing to provide informed consent.\n\nExclusion Criteria:\n\n* Patient is geographically inaccessible to comply and participate in the registry.",{"count":117,"type":21},500,"A registry of infants fitted with a cranial remolding orthosis.",[101,27,120],"Asymmetric Head",[122,123,124,125,126],"CRO","MyCRO","Cranial Helmet","Cranial Orthosis","Cranial Remolding Orthosis","2024-12-31",{"date":129,"type":38},"2025-01-07",{"date":131,"type":21},"2025-04",{"date":133,"type":21},"2030-04",{"name":135,"class":136},"Otto Bock HealthCare LP","INDUSTRY"]