Congenital Muscular TorticollisNCT06186323
Relationship Between Home Environment and Development in Children Diagnosed With Muscular Torticollis
An observational study of Congenital Muscular Torticollis and Motor Development, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 15 months
- Conditions the study is for
- Congenital Muscular Torticollis, Motor Development, Sensory Integration Disorder
- What is being tested?
- Affordances in the Home Environment for Motor Development-Infant Scale, Peabody Developmental Motor Scales-2 and Test Of Sensory Functions In Infants (TSFI)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2023to 1 Mar 2024
- 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 15 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 1-15 months, with parental consent,
- Diagnosed with congenital muscular torticollis
- Their families will be included.
Who cannot join
- Children with chromosomal anomalies,
- serious congenital problems
- those whose parents do not volunteer to participate will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Relationship Between Opportunities Offered in the Home Environment and Motor Development and Sensory Processing in Children Diagnosed With Congenital Muscular Torticollis
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.
Read the detailed description
It is thought that Congenital muscular torticollis (CMT) affects the muscles as well as the development of the head and face, causing various asymmetries, delays in gross motor functions, and disorders in posture and balance control. Bent neck position can cause plagiocephaly. Characteristic craniofacial deformities are asymmetry in the eyebrows 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. It has been shown that in later periods, it may cause asymmetry in the use of the upper extremities in children, delay in gross motor functions, and effects on posture and balance control. 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. Especially 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. This study was planned to examine the relationship between the opportunities offered in the home environment and motor development and sensory processing in children diagnosed with congenital muscular torticollis.
- Being tested
- Affordances in the Home Environment for Motor Development-Infant Scale, Peabody Developmental Motor Scales-2, Test Of Sensory Functions In Infants (TSFI)
- Keywords
- Torticollis, Motor development, Sensory Integration, Home environment
- 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.
Affordances in the Home Environment for Motor Development-Infant ScaleBehavioural
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.
Peabody Developmental Motor Scales-2Behavioural
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
Test Of Sensory Functions In Infants (TSFI)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Affordances in the Home Environment for Motor Development-Infant Scale; Behavioral: Peabody Developmental Motor Scales-2; Behavioral: Test Of Sensory Functions In Infants (TSFI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1-15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start10 Dec 2023
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
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 Congenital Muscular TorticollisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- 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 ERASLAN, Principal investigator, Study Principal Investigator-Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186323
- Sponsor's protocol ID
- Torticollis and affordance
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 19191832Sargent 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.
PubMed 31350358Cacola 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.
PubMed 25524875Chiarello 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.
PubMed 9474110
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Relationship Between Opportunities Offered in the Home Environment and Motor Development and Sensory Processing in Children Diagnosed With Congenital Muscular Torticollis
- ClinicalTrials.gov ID
- NCT06186323
- Acronym / sponsor ID
- Torticollis and affordance
- Keywords
- Torticollis, Motor development, Sensory Integration, Home environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 10 Dec 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 2 Jan 2024 (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.
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.
Detailed description
It is thought that Congenital muscular torticollis (CMT) affects the muscles as well as the development of the head and face, causing various asymmetries, delays in gross motor functions, and disorders in posture and balance control. Bent neck position can cause plagiocephaly. Characteristic craniofacial deformities are asymmetry in the eyebrows 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. It has been shown that in later periods, it may cause asymmetry in the use of the upper extremities in children, delay in gross motor functions, and effects on posture and balance control. 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. Especially 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. This study was planned to examine the relationship between the opportunities offered in the home environment and motor development and sensory processing in children diagnosed with congenital muscular torticollis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital muscular torticollis | – | Behavioral: Affordances in the Home Environment for Motor Development-Infant Scale, Behavioral: Peabody Developmental Motor Scales-2, Behavioral: Test Of Sensory Functions In Infants (TSFI)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. |
Who may qualify
- Ages
- 1 month to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged 1-15 months, with parental consent,
- Diagnosed with congenital muscular torticollis
- Their families will be included.
Key exclusion criteria (3 listed)
- Children with chromosomal anomalies,
- serious congenital problems
- those whose parents do not volunteer to participate 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affordances in the Home Environment for Motor Development-Infant ScaleAffordances 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. | Behavioural | congenital muscular torticollis |
| Peabody Developmental Motor Scales-2Peabody 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 | Behavioural | congenital muscular torticollis |
| Test Of Sensory Functions In Infants (TSFI)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 | Behavioural | congenital muscular torticollis |
Primary outcome
Affordances in the Home Environment for Motor Development-Infant Scale
Time frame: 1-15 months
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.
Peabody Developmental Motor Scales | Second Edition
Time frame: 1-15 months
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.
Test of Sensory Functıons ın Infants
Time frame: 1-15 months
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.
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 Mar 2024.
- 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.
- Results publication: PubMed 31350358Sargent 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.
- Results publication: PubMed 25524875Cacola 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.
- Results publication: PubMed 9474110Chiarello 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.
- 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 ERASLAN principal investigator
Study 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 Congenital Muscular Torticollis 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 3 inclusion and 3 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 Mar 2024. 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?
Affordances in the Home Environment for Motor Development-Infant Scale (time frame: 1-15 months). The study lists 3 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 NCT06186323, 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 Mar 2024.