Torticollis CongenitalNCT06879314
Development in Children Diagnosed With Congenital Muscular Torticollis
An observational study of Torticollis Congenital and Motor Development, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Torticollis Congenital, Motor Development, Sensory Integration Dysfunction
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Mar 2025to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Infants diagnosed with congenital torticollis between 0-12 months of age,
- with parental consent,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Torticollis, motor development, sensory processing skills, infant
- Medical subject headings
- Congenital torticollis, Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Healthy infants | A control group of 20 healthy children without congenital muscular torticollis will be formed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peabody Developmental Motor Scale | Second Edition
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.
Measured: 1-12 months
Test of Sensory Functions in Infants
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.
Measured: 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start13 Mar 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Torticollis CongenitalStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia ZORLULAR, Gazi University
- Investigators
- Rabia ZORLULAR, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879314
- Sponsor's protocol ID
- torticollis RZ
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19191832Zorlular R, Burak SE, Beyoglu R, Elbasan B. Motor development and sensory processing skills in infants with congenital muscular torticollis: a cross-sectional study. Eur J Pediatr. 2025 Sep 23;184(10):630. doi: 10.1007/s00431-025-06457-2.
PubMed 40986093
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Motor Development and Sensory Processing Skills in Children Diagnosed With Congenital Muscular Torticollis
- ClinicalTrials.gov ID
- NCT06879314
- Acronym / sponsor ID
- torticollis RZ
- Keywords
- Torticollis, motor development, sensory processing skills, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Healthy infants | – | –A control group of 20 healthy children without congenital muscular torticollis will be formed. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Infants diagnosed with congenital torticollis between 0-12 months of age,
- with parental consent,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publicationDeGangi, G.A. and S.I. Greenspan, Test of sensory functions in infants (TSFI). 1989: Western Psychological Services Los Angeles
- Results publicationFolio, M.R. and R.R. Fewell, Peabody developmental motor scales and activity cards. 1983: DLM Teaching
- Results publication: PubMed 19191832Ohman 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.
- Derived from this study: PubMed 40986093Zorlular R, Burak SE, Beyoglu R, Elbasan B. Motor development and sensory processing skills in infants with congenital muscular torticollis: a cross-sectional study. Eur J Pediatr. 2025 Sep 23;184(10):630. doi: 10.1007/s00431-025-06457-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia ZORLULAR principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Torticollis Congenital and Motor Development, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peabody Developmental Motor Scale | Second Edition (time frame: 1-12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06879314, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.