[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589677":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":39,"locations":49,"responsibleParty":65,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":94,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Istanbul University - Cerrahpasa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Telerehabilitation","EXPERIMENTAL","The telerehabilitation group receives the same structured, neurodevelopmentally-based rehabilitation program as the face-to-face group. However, the delivery method-via online video conferencing (Zoom)-represents a novel mode of application for this specific intervention in infants with congenital muscular torticollis (CMT).\n\nTo date, this therapeutic program has not been delivered through telehealth for this population, and its feasibility, effectiveness, and comparability to the conventional face-to-face method have not yet been studied. Therefore, this arm is considered experimental as it involves a new and previously untested method of intervention delivery, even though the therapeutic content remains the same.",[13],"Other: telerehabilitation",{"label":15,"type":16,"description":17,"interventionNames":18},"Face to face rehabilitation","ACTIVE_COMPARATOR","The face-to-face rehabilitation group receives a structured, neurodevelopmental treatment program that is already in routine clinical use for infants with congenital muscular torticollis (CMT). It represents the current standard method of delivering this intervention in clinical settings.\n\nSince the objective of the study is to compare the effectiveness of a novel telerehabilitation delivery model against this established, routinely used face-to-face method, the face-to-face arm serves as the active comparator. This arm provides a baseline for evaluating the outcomes of the experimental telerehabilitation approach.",[19],"Other: face to face rehabilitation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"face to face rehabilitation","The face-to-face rehabilitation program will be delivered in a clinical setting to infants aged 0-6 months with congenital muscular torticollis (CMT). It is based on neurodevelopmental treatment (NDT) principles and consists of:\n\nPassive range of motion (ROM) exercises for the neck\n\nActive ROM exercises for the neck and trunk\n\nActivities to promote the development of symmetrical movement\n\nEnvironmental modification suggestions for the home setting\n\nParent\u002Fcaregiver education and training\n\nSessions will be conducted twice per week, 30 minutes per session, over a total of 8 weeks.\n\nIn addition, an individualized home exercise program will be prescribed for each infant based on their specific needs. Frequency and duration of the home exercises may vary accordingly.",[15],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"telerehabilitation","The telerehabilitation program provides the same therapeutic content as the face-to-face rehabilitation group but will be delivered remotely via the Zoom video conferencing platform. The program will be applied to infants aged 0-6 months with congenital muscular torticollis (CMT) and is based on neurodevelopmental treatment (NDT) principles, including:\n\nPassive range of motion (ROM) exercises for the neck\n\nActive ROM exercises for the neck and trunk\n\nActivities for symmetrical movement development\n\nEnvironmental modification suggestions\n\nParent\u002Fcaregiver education and guidance\n\nSessions will be conducted via live video calls, twice per week, 30 minutes per session, for 8 weeks.\n\nEach family will also receive an individualized home exercise program, with its frequency and duration adapted to the infant's needs.",[9],[31,35],{"name":32,"affiliation":33,"role":34},"Nilay Arman","Istanbul University-Cerrahpasa,Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Division of Physiotherapy and Rehabilitation","STUDY_DIRECTOR",{"name":36,"affiliation":37,"role":38},"GÖKÇEN EROL","Istanbul University-Cerrahpasa, Graduate School of Health Sciences","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Gökçen EROL","CONTACT","+90553-464-66-06","fgokcenalaca@gmail.com",{"name":46,"role":42,"phone":47,"phoneExt":25,"email":48},"Nilay ARMAN","+90553-455-87-07","nilayarman@iuc.edu.tr",[50],{"facility":51,"status":25,"city":52,"state":25,"zip":53,"country":54,"countryCode":25,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Istanbul University - Cerrahpasa, Faculty of Health Sciences, Büyükçekmece Campus, Alkent 2000 Mah. Yiğittürk Street No:5\u002F9\u002F1, Büyükçekmece\u002FIstanbul, Turkey","Istanbul","34500","Turkey (Türkiye)",{"type":56,"coordinates":57},"Point",[58,59],28.94966,41.01384,{"lat":59,"lon":58},[62,63,64],{"name":36,"role":42,"phone":43,"phoneExt":25,"email":44},{"name":46,"role":42,"phone":47,"phoneExt":25,"email":48},{"name":36,"role":38,"phone":25,"phoneExt":25,"email":25},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gökçen Erol","MSc Physiotherapist","100589677","comparison-of-the-effectiveness-of-face-to-face-rehabilitation-and-telerehabilitation-in-infants-with-congenital-muscular-torticollis-100589677",false,"NCT06957522","Comparison of the Effectiveness of Face to Face Rehabilitation and Telerehabilitation in Infants With Congenital Muscular Torticollis","Inclusion Criteria:\n\n* Infants aged 0 to 6 months\n* Diagnosed with congenital muscular torticollis (CMT)\n* Classified as Grade 1 to 3 CMT severity based on clinical assessment\n\nExclusion Criteria:\n\n* Plagiocephaly\n* Ocular torticollis\n* Neurological complications\n* Musculoskeletal disorders of the cervical spine\n* Visual impairments\n* Hearing impairments","ALL","0 Months","6 Months",{"count":78,"type":79},42,"ESTIMATED","INTERVENTIONAL",[82],"NA","Who is this study for? This study is designed for infants aged 0-6 months who have been diagnosed with Congenital Muscular Torticollis (CMT). CMT is a condition observed at birth or shortly after, characterized by the shortening of the sternocleidomastoid (SCM) muscle, leading to the baby's head tilting to one side and rotating to the opposite side. It affects both boys and girls and may result in limited neck movement, abnormal posture, facial asymmetry, and potential developmental delays if left untreated.\n\nWhat is the purpose of this study? The goal of this study is to compare the effectiveness of two different physical therapy methods-face-to-face rehabilitation and telerehabilitation-in treating infants with CMT. In addition to evaluating the outcomes of these two therapy methods, this research also aims to provide families with reliable, accessible information through a web-based educational platform.\n\nWhy is this study important? Early diagnosis and intervention are crucial for optimal recovery in infants with CMT. Studies show that infants who begin therapy by one month of age have up to a 98% chance of full recovery. However, if diagnosis and treatment are delayed, the recovery process can take longer and may be less effective. This study will help determine if online (telerehabilitation) sessions can be just as effective as traditional face-to-face therapy, offering a flexible and accessible treatment option for families.\n\nWhat are the benefits of participating?\n\n* Access to a structured, evidence-based rehabilitation program for your child\n* Guidance from trained pediatric physiotherapists\n* Increased awareness and knowledge about CMT through a web-based family education platform\n* Contribution to research that may benefit other children and families in the future\n* Evaluation of your baby's progress through professional assessments\n\nWhat will the therapy program involve?\n\nParticipants will be randomly assigned to either a face-to-face or telerehabilitation group. Both groups will follow the same therapy program, focusing on:\n\n* Increasing passive and active neck movements\n* Promoting symmetrical head and body movement\n* Providing recommendations for environmental adjustments\n* Educating parents or caregivers on home-based exercises and care\n\nProgram structure:\n\n* Face-to-face group: Therapy sessions will be conducted in a clinic setting, twice a week for 30 minutes each session, over a period of 8 weeks.\n* Telerehabilitation group: Therapy sessions will be conducted via Zoom, with the same frequency, duration, and content as the face-to-face sessions.\n\nHow will outcomes be measured?\n\nInfants will be assessed before and after the 8-week therapy period for:\n\n* Passive cervical range of motion (rotation and lateral flexion)\n* Gross motor function\n* Muscle function Parental adherence to the home program will also be evaluated through a questionnaire. A follow-up will be conducted one month after therapy ends.\n\nHow can I participate? If your infant is aged 0-6 months and has been diagnosed with CMT, you may be eligible to participate. You will need access to a device with internet for telerehabilitation sessions, if assigned to that group. Participation is voluntary and free of charge. Families will receive detailed instructions and ongoing support throughout the program.\n\nAdditional Resources:\n\nAs part of this study, a web-based educational platform will be made available to all participating families. This platform will include:\n\n* Clear explanations about CMT\n* Instructional videos and home exercise guides\n* Tips for daily care and positioning\n* Frequently asked questions (FAQ) for parents Why is this research unique? This is one of the first studies to scientifically compare face-to-face and online rehabilitation for CMT infants, while also providing a reliable online resource for families. It aims to help develop alternative, flexible care models that meet the diverse needs of families and infants.\n\nContact Information:\n\nIf you are interested in participating or would like more information, please contact our research team at:\n\n\\[fgokcenalaca@gmail.com \u002F +905534646606\\] We are committed to supporting your child's health and development. Thank you for considering being a part of this important study.",[85,86,87,9,88],"Infant","Torticollis Congenital","Neurodevelopment Treatment","Physiotherapy and Rehabilitation",[27,90,91,92,93],"congenital torticollis","infant","neurodevelopment treatment","physiotherapy and rehabilitation","NOT_YET_RECRUITING","2025-04-25",{"date":97,"type":98},"2025-05-04","ACTUAL",{"date":100,"type":79},"2025-05-25",{"date":102,"type":79},"2026-12-25",{"name":5,"class":6},1]