[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658751":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":16,"studyPopulation":17,"armGroups":18,"interventions":24,"overallOfficials":29,"centralContacts":34,"locations":13,"responsibleParty":41,"collaborators":13,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":13,"eligibilityCriteria":50,"healthyVolunteers":47,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":13,"studyType":57,"phases":13,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":67,"whyStopped":13,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":13},{"fullName":5,"class":6},"Balgrist University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"1) Data completeness 2) Recruitment rate and dropout 3) Graph quality 4) Parent questionnaire 5) Time and logistical effort required by the study team","Data completeness: ≥80% of measurements successfully recorded, i.e. at least 4 out of 5 measurements per infant. Measured based on the number of successfully saved IMU datasets per participant.\n\nRecruitment rate and dropout rate\n\nGraph quality: Visual inspection by two persons based on the following criteria: initial line, continuous measurement line, unphysiological peaks, and clearly identifiable rotational movement. Target: ≥80% rated as good.\n\nParent questionnaire using a Likert scale: Comprehensibility of the SOP: ≥80% rated as \"good\u002Fvery good\"; feasibility: ≥80% rated as \"easy\u002Fvery easy\"; acceptance of the IMUs by the child: ≥80% rated as \"good\u002Fvery good.\"\n\nTime and logistical effort required by the study team: Documented and considered feasible if no delays occur.","From enrollment to end of data collection = 5 days",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":6,"timePerspective":15,"maskingInfo":13},"PROSPECTIVE","Your child will wear a baby hat with a small movement sensor (IMU, approximately, 10 g) and a soft chest strap with a second sensor during the first appointment (with a member of the study team). The measurements will take place at home on 5 consecutive days.\n\nProcedure: On the first day of measurement, a member of the study team will be present. They will explain exactly how the measurements should be carried out. You will also receive written instructions (Standard Operating Procedure). On the following four days, you will carry out the measurements yourself. You will encourage your child to turn their head using a rattle. This will take approximately 7-10 minutes. If you are unsure about anything or have any questions, the study team will be available by phone or online.\n\nDuration: Five consecutive days. On day 5, you will complete a short questionnaire about how easy the instructions were to understand, how well the movement sensors were accepted, how the measurements went, and the amount of effort involved.\n\nTime and effort required: 1 appointment with a member of the study team at your home (approximately 30-45 minutes) + 4 measurements carried out by yourself (approximately 7-10 minutes each) and, additionally, a questionnaire on day 5 (approximately 5 minutes).\n\nBenefits: Your child will not benefit directly from taking part in the study. In the future, the study may help to provide children with arthrogenic torticollis with a more accurate diagnosis and better monitoring of their treatment through improved measurement methods.\n\nRisks and burden: The risk is very low (Category A). The movement sensor is attached to a baby hat and does not come into direct contact with the skin. Your child will turn their head actively, and the movement will not be forced from the outside. If your child shows any signs of discomfort or resistance, the measurement can be stopped.","The study population includes infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment.",[19],{"label":20,"type":13,"description":21,"interventionNames":22},"Infants with athrogenic torticollis","Infants aged 3 to 8 months with arthrogenic torticollis (AT) or suspected dysfunction of the upper cervical spine who have been referred for chiropractic treatment. The study includes infants of both biological sexes.\n\nInclusion criteria:\n\nAge between 3 and 8 months at the time of the measurements Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine Written informed consent signed by the parents after they have received sufficient information about the study\n\nExclusion criteria:\n\nPrevious surgery or injury to the cervical spine Other systemic health conditions, e.g. cerebral palsy Developmental delay of the infant Insufficient German language skills of the parents to understand the informed consent form and to carry out the measure Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions",[23],"Other: Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)",[25],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":13},"Mobilisation of the upper cervical spine (but the effectiveness of the investigation is not part of the study evaluation)","Mobilisation of the upper cervical spine (C1\u002FC2).",[20],[30],{"name":31,"affiliation":32,"role":33},"Petra Schweinhardt, PhD","Balgrist University Hospital and University of Zurich","STUDY_CHAIR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Anke Langenfeld, PhD","CONTACT","+ 41 44 386","57 30","anke.langenfeld@balgrist.ch",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Schweinhardt Petra","Prof. Dr. med","100658751","assessment-of-cervical-range-of-motion-restrictions-in-infants-with-arthrogenic-torticollis---a-feasibility-study-100658751",false,"NCT07855731","Assessment of Cervical Range of Motion Restrictions in Infants With Arthrogenic Torticollis - A Feasibility Study","Inclusion Criteria:\n\n* Age between 3 and 8 months at the time of the measurements\n* Referral for chiropractic treatment with suspected AT or suspected dysfunction of the upper cervical spine\n* Written informed consent signed by the parents after they have received sufficient information about the study-\n\nExclusion Criteria:\n\n* Previous surgery or injury to the cervical spine\n* Other systemic health conditions, e.g. cerebral palsy\n* Developmental delay of the infant\n* Insufficient German language skills of the parents to understand the informed consent form and to carry out the measurements independently\n* Excessive distress or resistance by the infant, such as crying, screaming, or similar reactions","ALL","3 Months","8 Months",{"count":55,"type":56},10,"ESTIMATED","OBSERVATIONAL","Babies with torticollis (a tilted or twisted neck) have difficulty turning their head fully to the side. Small movement sensors = Inertial Measurement Units (IMUs) can be used to measure how far they can turn their head. In an earlier study, these measurements were carried out by a trained professional. We now want to find out whether parents can do the measurements themselves at home and whether this works well in everyday practice.",[60],"Torticollis (Arthrogenic)",[62,63,64,65,66],"Infant","Cervical range of motion","arthrogenic torticollis","feasibility","Intertial measurement unit","NOT_YET_RECRUITING","2026-10-06",{"date":70,"type":71},"2026-10-08","ACTUAL",{"date":73,"type":56},"2026-10-07",{"date":75,"type":56},"2027-03-31",{"name":5,"class":6}]