[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509764":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":22,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":22,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":46,"whyStopped":22,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,13,18],{"label":9,"type":6,"description":10,"interventionNames":11},"Repositioning Therapy","Infants will be treated with at-home repositioning strategies for their deformational head shape. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.",[12],"Other: Repositioning Therapy",{"label":14,"type":6,"description":15,"interventionNames":16},"Repositioning Therapy + Cranial Remolding Orthoses","After attempting at 2-4 months of repositioning therapy, infants with residual cranial deformation may be treated with a custom made helmet (cranial remolding orthosis) which is adjusted every few weeks to direct skull growth. It is worn 23 hours per day. Physical therapy will be provided, if indicated, for treatment of torticollis. This is a standard treatment.",[12,17],"Device: Cranial Remolding Orthosis",{"label":19,"type":20,"description":21,"interventionNames":22},"Control","NO_INTERVENTION","Healthy infants without deformational head shapes or need for physical therapy will be followed and measured. No intervention.",null,[24,27],{"type":6,"name":9,"description":25,"armGroupLabels":26,"otherNames":22},"Caregivers will be instructed how to increase tummy time activities and reshape their infant's heads using at-home methods to direct their attention to the non-preferred side.",[9,14],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Cranial Remolding Orthosis","A custom cranial remolding orthosis (FDA Class II device) will be made to fit affected infants. this should be worn 23 hours per day and the Orthotist needs to be seen regularly for adjustments until the head shape is resolved.",[14],[33],"Helmet, Cranial Band, STARband",[35],{"name":36,"affiliation":5,"role":37},"Tiffany Graham","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":22,"email":43},"Tiffany Graham, MSPO","CONTACT","214-645-8250","Tiffany.Graham@utsouthwestern.edu",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Dallas","Texas","75390","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-96.80667,32.78306,{"lat":56,"lon":55},[59,60,63,65,67,69],{"name":40,"role":41,"phone":42,"phoneExt":22,"email":43},{"name":61,"role":62,"phone":22,"phoneExt":22,"email":22},"Rami Hallac, PhD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":22,"phoneExt":22,"email":22},"Jijia Wang, PhD",{"name":66,"role":62,"phone":22,"phoneExt":22,"email":22},"Alex Kane, MD",{"name":68,"role":62,"phone":22,"phoneExt":22,"email":22},"Caitlin Deville, DSc",{"name":70,"role":62,"phone":22,"phoneExt":22,"email":22},"Susan Simpkins, EdD",{"type":37,"investigatorFullName":36,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Assistant Professor",[74],{"name":75,"class":6},"Children's Health","100509764","effectiveness-of-repositioning-and-cranial-remolding-in-infants-with-cranial-deformation-100509764",false,"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,"ALL","2 Months","3 Months",{"count":88,"type":89},65,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95,96,97,98,99],"Deformational Plagiocephaly","Deformational Posterior Plagiocephaly","Brachycephaly","Torticollis","Congenital Muscular Torticollis",[101,102,103,104,105,106,107,108,109,110],"plagiocephaly","brachycephaly","asymmetrical brachycephaly","helmet","cranial remolding","orthosis","repositioning","deformational","torticollis","normal","2025-08-21",{"date":113,"type":114},"2025-08-28","ACTUAL",{"date":116,"type":114},"2023-05-23",{"date":118,"type":89},"2026-07-01",{"name":5,"class":6},1]