- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879314
Development in Children Diagnosed With Congenital Muscular Torticollis
June 24, 2025 updated by: Rabia ZORLULAR, Gazi University
Investigation of Motor Development and Sensory Processing Skills in Children Diagnosed With Congenital Muscular Torticollis
It has been thought that head position may affect the shoulder, rib cage and abdominal muscles, which may have a negative effect on posture control and movement development, sensory-motor coordination and cause retardation in gross motor function.
For these reasons, children with congenital muscular torticollis should be evaluated comprehensively in the early period.
This study, which was planned to evaluate the motor development and sensory processing of children with torticollis, was designed according to the lack of literature.
Study Overview
Status
Completed
Detailed Description
Congenital muscular torticollis (CMT) is a common postural deformity that occurs shortly after birth and is typically characterized by ipsilateral cervical lateral flexion and contralateral cervical rotation due to unilateral shortening of the sternocleidomastoid (SCM) muscle.
It is a non-neurological postural disorder that usually affects 3% to 16% of infants.
Theories such as intrauterine stenosis, vascular causes, fibrosis of the peripartum hemorrhage area, difficult labor, and primary myopathy of the SCM muscle have been put forward for its causes.
In tissue samples taken after surgery, edema, degeneration of muscle fibers, and fibrosis have been reported.
It is thought that CMT affects the muscles as well as head and facial development, causing various asymmetries, delays in gross motor functions, and disorders in posture and balance control.
A bent neck position can cause plagiocephaly.
Characteristic craniofacial deformities include asymmetry in the brow and cheekbones, deviation of the chin and nose tip, inferior orbital abnormality on the affected side, asymmetry in ear placement, and shortening of the vertical dimension of the ipsilateral face.
In later periods, it has been shown that it may cause asymmetry in the use of the upper extremities, delay in gross motor functions, and effects on posture and balance control in children.
It is thought that head position may affect the shoulder, rib cage, and abdominal muscles, which may have a negative effect on posture control and movement development, sensory-motor coordination, and cause gross motor function retardation.
For these reasons, children with congenital muscular torticollis should be evaluated comprehensively in the early period.
This study, which was planned to evaluate the motor development and sensory processing of children with CMT, was designed according to the lack of literature.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Gazi University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Congenital muscular torticollis (CMT) is a common postural deformity that appears shortly after birth and is typically characterized by ipsilateral cervical lateral flexion and contralateral cervical rotation due to unilateral shortening of the sternocleidomastoid (SCM) muscle.
It is a non-neurological postural disorder that usually affects 3% to 16% of infants.
CMT is the third most common musculoskeletal disorder of infancy, affecting 3.9% to 16% of infants.
It develops due to unilateral shortening of the SCM, regardless of whether there is a mass in the SCM.
CMT is characterized by lateral flexion of the affected SCM to the ipsilateral side and rotation to the contralateral side.
Description
Inclusion Criteria:
- Infants diagnosed with congenital torticollis between 0-12 months of age,
- with parental consent,
Exclusion Criteria:
- Children with chromosomal abnormalities,
- serious congenital problems,
- vision-hearing problem
- children whose parents do not volunteer for the study will not be included in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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torticollis
Twenty children with congenital muscular torticollis diagnosis, between 0-12 months of age, with parental consent, without any vision or hearing problems, will be included in the study.
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Healthy infants
A control group of 20 healthy children without congenital muscular torticollis will be formed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Sensory Functions in Infants
Time Frame: 1-12 months
|
It was planned to use the Test of Sensory Functions in Infants to evaluate the sensory development of infants.
Test of Sensory Functions in Infants is frequently used to evaluate the sensory processing functions of infants aged 4-18 months.
It is used to determine whether an infant has a sensory processing problem and to what extent.
It consists of 24 items.
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1-12 months
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Peabody Developmental Motor Scale | Second Edition
Time Frame: 1-12 months
|
It is planned to use Peabody Motor Development Scale-2 to evaluate motor development.
The test is designed to determine developmental delays in children between 0-72 months.
It is used to evaluate the motor development of children with separate tests and rating scales for both gross motor skills and fine motor skills.
Six subtests, reflexes, Stationary, Locomotion, Object Manipulation, Grasping, and Visual-Motor Integration, collectively measure a broad spectrum of motor functions including postural control, locomotor abilities, object manipulation, and hand-eye coordination.
The subtests generate three composite scores: the Gross Motor Quotient, Fine Motor Quotient, and Total Motor Quotient, offering a comprehensive evaluation of a child's motor competence.
Notably, higher scores on the Peabody Motor Development Scale-2 reflect superior motor performance, indicating better developmental outcomes.
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1-12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rabia ZORLULAR, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- DeGangi, G.A. and S.I. Greenspan, Test of sensory functions in infants (TSFI). 1989: Western Psychological Services Los Angeles
- Folio, M.R. and R.R. Fewell, Peabody developmental motor scales and activity cards. 1983: DLM Teaching
- Ohman A, Nilsson S, Lagerkvist AL, Beckung E. Are infants with torticollis at risk of a delay in early motor milestones compared with a control group of healthy infants? Dev Med Child Neurol. 2009 Jul;51(7):545-50. doi: 10.1111/j.1469-8749.2008.03195.x. Epub 2009 Jan 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 13, 2025
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
April 30, 2025
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 13, 2025
First Posted (Actual)
March 17, 2025
Study Record Updates
Last Update Posted (Estimated)
June 25, 2025
Last Update Submitted That Met QC Criteria
June 24, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- torticollis RZ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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