NCT06186323

Brief Summary

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 (SKM) muscle. It is a non-neurological postural disorder that generally affects 3% to 16% of babies. Theories such as intrauterine stenosis, vascular causes, fibrosis of the peripartum bleeding area, difficult birth, and primary myopathy of the SCM muscle have been put forward for its causes.Head position; It is thought that it may cause a negative impact on posture control and movement development, sensorimotor coordination, and retardation in gross motor function by affecting the shoulder, rib cage and abdominal muscles. Motor skills and sensory experiences begin to develop after birth and development continues as children grow. Having good motor control also helps children explore the world around them, which can help many other areas of development. There are many environmental and biological factors that affect motor development. In particular, the home environment, where the child spends most of his time, is one of the key factors affecting motor development. The home environment is known to be a very important factor for motor development in babies. At the same time, the variety of equipment and environmental conditions help children provide different sensory experiences. Since it is a common practice for physiotherapists to advise patients on home activities, exploring the home environment can have important effects on development. For these reasons, it was thought that the motor development and sensory processing suggestions given in the home environment for children diagnosed with torticollis would be supported by home environment opportunities.

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 Dec 2023

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

Study Start

First participant enrolled

December 10, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

December 15, 2023

Last Update Submit

March 22, 2024

Conditions

Keywords

TorticollisMotor developmentSensory IntegrationHome environment

Outcome Measures

Primary Outcomes (3)

  • Affordances in the Home Environment for Motor Development-Infant Scale

    Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces. The scale consists of 41 items in total. For babies aged 3-12 months, questions up to the first 32 items are answered. It is stated that other substances are not suitable for babies under 12 months. All substances are applied to babies between 12-18 months. Questions answered as yes or no are scored as 0.1 (0: no, 1: yes). Other questions are scored as 0, 1, 2, 3. For babies up to 12 months, a total of 66 points is obtained. For babies older than 12 months, a total of 93 points is obtained. A higher score indicates better environmental enrichment.

    1-15 months

  • Peabody Developmental Motor Scales | Second Edition

    Peabody Developmental Motor Scales \| Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years. It consists of gross motor and fine motor parts. The Gross motor section includes 151 items from 4 subtests: reflexes, stasis, locomotion, and object manipulation. The fine motor section consists of 2 subtests and 98 items: comprehension and visual-motor integration. The total motor part is the sum of the items in the gross and fine 25 motor parts. Items are scored with 0, 1, and 2 points. When the child performs the item according to the specified item criteria, 2 points are given. 1 point is awarded when the behavior occurs but the criteria for successful performance are not fully met. A score of 0 is given when the child is unable to try the item or does not reveal any skills when he tries it. Results are expressed as a raw score, standard score, or total motor score.

    1-15 months

  • Test of Sensory Functıons ın Infants

    It was planned to useTest of Sensory Functıons ın Infants (TSFI) to evaluate the sensory development of babies. BDFT is frequently used to evaluate the sensory processing functions of babies aged 4-18 months. It is used to determine whether a baby has a sensory processing problem and to what extent. It consists of 24 items.

    1-15 months

Study Arms (1)

congenital muscular torticollis

40 children diagnosed with congenital muscular torticollis, aged 0-15 months, with parental consent, without any vision or hearing problems, will be included in the study. Children with chromosomal anomalies, serious congenital problems and whose parents do not volunteer to participate will not be included in the study. During the evaluations, the demographic characteristics of the babies (gender, gestational age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score) will be recorded from the file and by interviewing the family. Photographs will be taken to ensure an objective evaluation. The Affordances in the Home Environment for Motor Development-Infant Scale will be used to explore and evaluate the home environment. It was planned to use the Test of Sensory Functions in Infants to evaluate the sensory development of babies. It is planned to use Peabody Motor Development Scale-2 to evaluate motor development.

Behavioral: Affordances in the Home Environment for Motor Development-Infant ScaleBehavioral: Peabody Developmental Motor Scales-2Behavioral: Test Of Sensory Functions In Infants (TSFI)

Interventions

Affordances in the Home Environment for Motor Development-Infant Scale is a parent-filled assessment to determine the nature and amount of factors affecting infant motor skill development in the home environment, including the availability of toys, materials, and the availability of spaces.

congenital muscular torticollis

Peabody Developmental Motor Scales \| Second Edition (PDMS-2) combines in-depth assessment with training or remediation of gross and fine motor skills of children from birth through 5 years. Used to evaluate children's motor development with separate tests and rating scales for both gross motor skills and fine motor skills

congenital muscular torticollis

his test helps you identify infants with sensory integrative dysfunction-including those at risk for developing learning disabilities as they grow older. The TSFI provides objective criteria that allow you to determine whether, and to what extent, an infant has deficits in sensory functioning. Designed for use with children from 4 months to 18 months old, the TSFI provides an overall measure of sensory processing and reactivity, as well as scores on the following subdomains: Reactivity to Tactile Deep Pressure Visual Tactile Integration Adaptive Motor Function Ocular Motor Control Reactivity to Vestibular Stimulation

congenital muscular torticollis

Eligibility Criteria

Age1 Month - 15 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

40 children diagnosed with congenital muscular torticollis, aged 0-15 months, with parental consent, without any vision or hearing problems, will be included in the study. severe chromosomal abnormality Children with congenital problems and whose parents do not volunteer to participate will not be included in the study.

You may qualify if:

  • Children aged 1-15 months, with parental consent,
  • Diagnosed with congenital muscular torticollis
  • Their families will be included.

You may not qualify if:

  • Children with chromosomal anomalies,
  • serious congenital problems
  • those whose parents do not volunteer to participate will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabia ERASLAN

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

  • Sargent B, Kaplan SL, Coulter C, Baker C. Congenital Muscular Torticollis: Bridging the Gap Between Research and Clinical Practice. Pediatrics. 2019 Aug;144(2):e20190582. doi: 10.1542/peds.2019-0582.

  • Cacola PM, Gabbard C, Montebelo MI, Santos DC. Further Development and Validation of the Affordances in the Home Environment for Motor Development-Infant Scale (AHEMD-IS). Phys Ther. 2015 Jun;95(6):901-23. doi: 10.2522/ptj.20140011. Epub 2014 Dec 18.

  • Chiarello LA, Palisano RJ. Investigation of the effects of a model of physical therapy on mother-child interactions and the motor behaviors of children with motor delay. Phys Ther. 1998 Feb;78(2):180-94. doi: 10.1093/ptj/78.2.180.

MeSH Terms

Conditions

Congenital torticollisTorticollis

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabia ERASLAN

    Study Principal Investigator-Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 2, 2024

Study Start

December 10, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations