[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"orthosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:orthosis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,77],{"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":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100592108","effects-of-orthosis--exercise-on-spondylolisthesis-100592108","NCT06989138","Effects of Orthosis & Exercise on Spondylolisthesis","The Effect of Orthosis and Exercise Training on Pain, Physical Function and Quality of Life in Patients With Spondylolisthesis","Inclusion Criteria:\n\n* Individuals aged 18-65\n* Individuals without indication for surgery\n* Individuals diagnosed with grade 1-2 spondylolysis\n* Individuals without neurological deficits\n* Individuals diagnosed with radicular pain or non-specific chronic low back pain for more than 3 months\n\nExclusion Criteria:\n\n* Surgery recommended after diagnosis\n* History of lumbar surgery\n* Presence of rheumatic inflammatory diseases or diabetic polyneuropathy\n* Individuals with symptoms of cauda equina or ischemic heart disease\n* Presence of back pain with non-mechanical causes or non-radicular neuropathic pain\n* Having received this type of exercise therapy before","18 Years","65 Years",{"count":54,"type":21},48,"INTERVENTIONAL",[57],"NA","In the treatment of spondylolisthesis, conservative methods are initially preferred unless severe neurological symptoms are present; surgical treatment is only performed in refractory cases lasting at least 3-6 months. Conservative treatment consists of orthotic use, activity restriction, pain control, physiotherapy and exercise. Orthotics may promote healing by restricting movement; however, there are not enough studies on this subject. Exercise is the intervention with the highest level of evidence in chronic low back pain. The efficacy of stabilisation exercises in providing positive and long-lasting effects on pain and functional disability in patients with spondylolisthesis has been demonstrated. However, studies evaluating the effect of exercise on spinal stability and radiological findings are limited. Therefore, this study aims to compare the effects of stabilization and conventional exercises with orthosis on radiographic findings, pain, physical function and quality of life.",[60,28,61],"Spondylolisthesis","Exercise Training",[60,28,63,64,65,66],"Exercise","Stabilization","Physical function","Kinesiophobia","NOT_YET_RECRUITING","2025-05-21",{"date":70,"type":35},"2025-05-25",{"date":72,"type":21},"2025-05",{"date":74,"type":21},"2026-07",{"name":76,"class":42},"Medipol University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":85,"targetDuration":4,"studyType":55,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":43},"100293225","orthosis-vs-no-orthosis-after-surgically-treated-traumatic-thoracolumbar-fractures-100293225","NCT03097081","ORthosis vs No Orthosis After Surgically Treated Traumatic Thoracolumbar Fractures","Orthosis Versus no Orthosis After Dorsally Fixated Traumatic Thoracolumbar Fractures","ORNOT","Inclusion Criteria:\n\n* Age 18 - 65 years\n* Traumatic thoracolumbar spine fracture from thoracic 7 - lumbar 4\n* AO fracture types A-C\n* Undergoing surgical dorsal fixation for fracture\n\nExclusion Criteria:\n\n* Inadequate knowledge of Dutch language or to fill in questionnaire\n* Complete or partial spinal cord injury (ASIA A to D)\n* (Additional) anterior surgical stabilization\n* Thoracolumbar fracture of other aetiology than traumatic, e.g. pathologic, infectious\n* Not able to walk before fracturing vertebra\n* Unable to come to the outpatient clinic (e.g. residing outside the Netherlands)\n* Injury Severity Score (ISS) ≥ 16\n* Brain injury with Abbreviated Injury Score (AIS) ≥ 4\n* Solitary Lumbar 5 fracture\n* Inability to wear an orthosis, most probable reasons:\n\n  * BMI \\> 35\n  * Thoraco-abdominal wounds (through trauma or secondary from surgery) on places at which the orthosis contacts the body so aggravation of pain or chances of infection increase significantly.\n\n    12 of 27\n  * Pre-existing spine deformities (scoliosis or very severe kyphosis\u002Flordosis) which impair the use of the orthosis or aggravate pain.",{"count":86,"type":21},45,[57],"Rationale: There is no evidence in the current literature regarding the additional value of an orthosis after surgically treated thoracolumbar spine fractures.\n\nObjective: To assess whether an orthosis provides additional pain relief compared to no orthosis after posteriorly fixated thoracolumbar spine fractures. Primary outcome is difference in pain at six weeks post-operatively. Secondary objectives are pain at other moments, pain medication used, pain related disability, quality of life, long-term kyphosis, possible complications, hospital stay, return to work and subjective feeling on benefit or disadvantage from the orthosis.\n\nStudy design: Randomized controlled intervention study, non-inferiority trial.\n\nStudy population: Dutch speaking patients presented at the VU university medical centre, 18 - 65 years old with a traumatic thoracolumbar spine fracture from Th7 - L4 surgically treated by posterior fixation.\n\nIntervention: One group receives standard care and wears an orthosis after surgery for 12 weeks, to use when in vertical position. The intervention group does not wear an orthosis after surgery.\n\nMain study parameters\u002Fendpoints: Main study outcome is the difference in pain noted on the NRS-score at six weeks, ≥ 2 (SD 2,5) change corresponds with a clinically significant change in pain score.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The current guideline for postoperative care regarding dorsal stabilization of spine fractures recommends the use of a post-operative orthosis. While patients generally receive an orthosis for 12 weeks, individual surgeon's believes sometimes gives reason to deviate from this guideline. This is founded by literature that increasingly questions the use of orthoses in the conservative treatment of spine fractures. With the fracture operatively stabilized, the orthosis mainly provides support of gesture and thereby potentially results in pain relief and confidence for patients. On the other hand some patients have a hard time weaning from the orthosis or report discomfort due to the device and prefer not to use it. With subjects being randomized between the use of an orthosis or no orthosis there is no additional risk. This is in part because it is hypothesized that there is no difference in postoperative pain and there might be a lower risk of complications related to the orthosis.",[90,28,91,92],"Spine Fracture","Traumatic Fracture","Posterior Fixation","2023-01-21",{"date":95,"type":35},"2023-01-25",{"date":97,"type":4},"2016-11",{"date":99,"type":21},"2026-11",{"name":101,"class":42},"Amsterdam UMC, location VUmc"]