NCT06879314

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 10, 2025

Last Update Submit

June 24, 2025

Conditions

Keywords

Torticollismotor developmentsensory processing skillsinfant

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1-12 months

Study Arms (2)

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.

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Infants diagnosed with congenital torticollis between 0-12 months of age,
  • with parental consent,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • DeGangi, G.A. and S.I. Greenspan, Test of sensory functions in infants (TSFI). 1989: Western Psychological Services Los Angeles

    BACKGROUND
  • Folio, M.R. and R.R. Fewell, Peabody developmental motor scales and activity cards. 1983: DLM Teaching

    BACKGROUND
  • 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.

    PMID: 19191832BACKGROUND
  • Zorlular 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.

MeSH Terms

Conditions

Congenital torticollisTorticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabia ZORLULAR

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 17, 2025

Study Start

March 13, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations