[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plagiocephaly\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plagiocephaly":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,78,101],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100620344","associations-of-cranial-outcomes-and-parental-expectations-and-satisfaction-100620344",false,"NCT07356401","Associations of Cranial Outcomes and Parental Expectations and Satisfaction","Association Between Cranial Morphological Changes, Parental Expectations, and Satisfaction Following Cranial Remolding Orthosis Treatment in Infants","Inclusion Criteria:\n\n* Infants diagnosed with positional cranial deformities (e.g., plagiocephaly, brachycephaly, or asymmetrical cranial shape)\n* Infants who received cranial remolding orthosis treatment\n* Use of a custom-made cranial remolding orthosis\n* Availability of pre-treatment and post-treatment cranial measurements\n* Parents or legal guardians who provided informed consent and were able to complete expectation and satisfaction questionnaires\n* Infants who completed the planned cranial remolding orthosis treatment and follow-up period\n\nExclusion Criteria:\n\n* Infants with neurological disorders, genetic syndromes, or congenital conditions affecting cranial growth\n* Infants who underwent previous cranial surgery or other cranial interventions\n* Infants who received non-custom-made or prefabricated cranial orthoses\n* Incomplete clinical records or missing pre- or post-treatment cranial measurements\n* Parents or caregivers unable to complete the questionnaires due to language or cognitive limitations\n* Infants with a diagnosis of microcephaly or macrocéphaly.","ALL","3 Months","18 Months",{"count":20,"type":21},20,"ESTIMATED","1 Month","OBSERVATIONAL","This study aims to investigate the association between objective cranial morphological changes and parental expectations and satisfaction in infants undergoing treatment with a cranial remolding orthosis (CRO). Infants diagnosed with positional cranial deformities and prescribed CRO treatment will be included. Cranial morphological outcomes will be assessed using standardized cranial measurements obtained before and after the treatment period.\n\nParental treatment expectations will be evaluated prior to the initiation of CRO therapy using the Treatment Expectation Questionnaire (TR.TEX-Q), while parental satisfaction with the device and treatment process will be assessed at the end of treatment using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST).\n\nThe primary objective of the study is to examine the relationships between changes in cranial morphology and parental expectations and satisfaction scores. Secondary objectives include exploring the association between baseline expectations and post-treatment satisfaction. The findings are expected to provide insight into how objective treatment outcomes align with family-reported perceptions in cranial remolding orthosis therapy.",[26,27,28,29,30],"Plagiocephaly","Cranial Defect","Orthosis","Expectancy","Satisfaction","RECRUITING","2026-01-22",{"date":34,"type":35},"2026-01-26","ACTUAL",{"date":37,"type":35},"2025-11-25",{"date":39,"type":21},"2026-03-15",{"name":41,"class":42},"Gulhane School of Medicine","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":43},"100504481","opt-in-osteopathic-plagiocephaly-treatment-for-infants-and-neonates-100504481","NCT05848895","OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates","OPT-IN","Inclusions:\n\n* Diagnosed with positional plagiocephaly\n* Under 4-months of age (between birth - 4 months) at the time of enrollment\n\nExclusions:\n\n* Preterm birth (\\\u003C37 weeks)\n* Genetic syndromes\n* Craniofacial defects\u002Fdeformities (e.g. cleft lip\u002Fpalate)\n* Brachycephaly\u002Fscaphocephaly\n* Hypotonia\n* Hypertonia\n* Craniosynostosis\n* Head trauma or other neurological illnesses\n* Lost to follow up\n* Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions\n* Prior helmet therapy, physical therapy, or OMT before the date of enrollment","1 Day","4 Months",{"count":54,"type":21},122,"INTERVENTIONAL",[57],"NA","The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional\u002Fdeformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning.\n\nThis is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants \\\u003C4 months of age) will be organized into one of two groups:\n\n1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.\n2. Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy).\n\nTimeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.",[60,61,26,62],"Plagiocephaly, Nonsynostotic","Plagiocephaly, Positional","Cranium; Deformity",[64,65,66,67,68],"Positional Plagiocephaly","Nonsynostotic Plagiocephaly","Repositioning","Osteopathic Manipulative Treatment","Cranial asymetry","2025-07-30",{"date":71,"type":35},"2025-08-03",{"date":73,"type":35},"2023-10-26",{"date":75,"type":21},"2025-12",{"name":77,"class":42},"Osteopathy's Promise to Children",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"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",{"count":86,"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).",[26,89,90,91],"Brachycephaly","Deformational Plagiocephaly","Deformational Posterior Plagiocephaly","2025-07-01",{"date":94,"type":35},"2025-07-03",{"date":96,"type":35},"2024-08-19",{"date":98,"type":21},"2026-06-01",{"name":100,"class":42},"University of Texas Southwestern Medical Center",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":107,"targetDuration":109,"studyType":23,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":43},"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":108,"type":21},500,"6 Months","A registry of infants fitted with a cranial remolding orthosis.",[26,89,112],"Asymmetric Head",[114,115,116,117,118],"CRO","MyCRO","Cranial Helmet","Cranial Orthosis","Cranial Remolding Orthosis","NOT_YET_RECRUITING","2024-12-31",{"date":122,"type":35},"2025-01-07",{"date":124,"type":21},"2025-04",{"date":126,"type":21},"2030-04",{"name":128,"class":129},"Otto Bock HealthCare LP","INDUSTRY"]