Congenital Muscular TorticollisNCT06225934
The Effect of Home Exercise Programs Applied of Congenital Muscular Torticollis.
An observational study of Congenital Muscular Torticollis and Family Members, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Congenital muscular torticollis (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, whether or not there is a mass in the sternocleidomastoid muscle (SCM). Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Congenital Muscular Torticollis, Family Members
- What is being tested?
- Exercise and home program to increase lateral flexion and rotation angles
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 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 12 months
- All sexes
- Child
Study population: Fifteen babies diagnosed with congenital muscular torticollis (CMT) who are between 0-12 months old and agree to participate in the study will be included in the study. Congenital muscular torticollis (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 sternocleidomastoid muscle (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
- Babies aged 0-12 months with a diagnosis of congenital muscular torticollis (CMT)
- Families who agree to participate in the study will be included in the exercise program
Who cannot join
- Those who have any neurological risk factors were included in the study,
- Those who are affected by their visual/hearing senses,
- Those who have not been diagnosed with Congenital muscular torticollis (CMT) by a doctor,
- Those who have previously received treatment for the diagnosis of CMT,
- Babies with a history of BOTOX-A/surgery applied to the Sternocleidomastoid (SKM) muscle before treatment will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Rabia ZORLULAR
Ankara
Rabia ZORLULAR, +905424362082, rabiaeraslan118@gmail.com
About this study
Official title: The Effect of Home Exercise Programs Applied in Cooperation With the Family on the Treatment of Congenital Muscular Torticollis.
Congenital muscular torticollis (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, whether or not there is a mass in the sternocleidomastoid muscle (SCM). CMT is characterized by lateral flexion of the affected SCM to the ipsilateral side and rotation to the contralateral side. Its etiology is not fully known. However, it can be associated with SCM disorder that develops due to birth trauma, prenatal/perinatal compartment syndrome and intrauterine restriction. It has been reported that conditions such as multiple pregnancy, intrauterine stenosis, vascular causes, fibrosis of the peripartum bleeding area, use of forceps at birth, difficult birth, and primary myopathy of SCM increase the possibility of CMT. It is necessary to approach babies diagnosed with CMT with an effective treatment program. The most important and effective of these approaches is to provide the necessary education and an intensive home program to their families, with whom they spend most of their days. By educating the family, on the one hand, the baby will receive regular treatment and the family's communication with the baby will be strengthened, while on the other hand, limitations such as transportation, time and cost will be eliminated. In our study; It was aimed to examine the effectiveness of the home program given in cooperation with the family in babies diagnosed with CMT and to create a new protocol.
Read the detailed description
Congenital muscular torticollis (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, whether or not there is a mass in the sternocleidomastoid muscle (SCM). CMT is characterized by lateral flexion of the affected SCM to the ipsilateral side and rotation to the contralateral side. Its etiology is not fully known. However, it can be associated with SCM disorder that develops due to birth trauma, prenatal/perinatal compartment syndrome and intrauterine restriction. It has been reported that conditions such as multiple pregnancy, intrauterine stenosis, vascular causes, fibrosis of the peripartum bleeding area, use of forceps at birth, difficult birth, and primary myopathy of SCM increase the possibility of CMT. These conditions cause degeneration of SCM fibers, edema in SCM, and fibrosis, as well as the general posture seen in SCM. Although CMT seems to be a condition that only concerns the neck muscles; In later periods, it may cause permanent disorders in body biomechanics such as asymmetry in the use of the upper extremities, delay in gross motor functions, postural disorders such as plagiocephaly and scoliosis, and balance disorders. Therefore, babies diagnosed with CMT should be included in a comprehensive and regular physiotherapy and rehabilitation program from the early period. These programs generally include joint range of motion-stretching exercises for the neck, family education including teaching the principles of holding and carrying, approaches such as microcurrent applications and taping, and in more severe cases, botulinum toxin-A (BOTOX-A) or surgical applications. It is necessary to approach babies diagnosed with CMT with an effective treatment program. The most important and effective of these approaches is to provide the necessary education and an intensive home program to their families, with whom they spend most of their days. By educating the family, on the one hand, the baby will receive regular treatment and the family's communication with the baby will be strengthened, while on the other hand, limitations such as transportation, time and cost will be eliminated. In our study; It was aimed to examine the effectiveness of the home program given in cooperation with the family in babies diagnosed with CMT and to create a new protocol.
In our study; It is aimed to examine the effect of the home program given to babies diagnosed with Congenital Muscular Torticollis (CMT) between the ages of 0-12 months, in cooperation with the family, on the treatment of CMT and to contribute to the literature with this approach that can be used by clinicians by creating a treatment protocol for this.
- Conditions
- Congenital Muscular Torticollis, Family Members
- Being tested
- Exercise and home program to increase lateral flexion and rotation angles
- Keywords
- Cooperation with the family, Congenital Muscular Torticollis
- Medical subject headings
- Congenital torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and home program to increase lateral flexion and rotation anglesBehavioural
Suggestions will be made to the parent/caregiver of the baby diagnosed with congenital muscular torticollis (CMT) participating in the study to increase the baby's decreasing lateral flexion and rotation angles, and parents/caregivers will be advised to integrate these suggestions into their daily routine as much as possible.These suggestions; It includes holding-carrying-breastfeeding (feeding) principles, active-passive lateral flexion and active stretching of the child and activities that will increase joint range of motion for the SCM muscle, environmental arrangements, games that enable the development of active symmetrical movements and prone activities. The home program to be implemented by parents/caregivers will continue for 6 weeks. During the evaluations, the demographic characteristics of the babies (gender, gestational age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score, ultrasonography values, etc.) will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| congenital muscular torticollis | Babies diagnosed with congenital muscular torticollis (CMT) who agree to participate in the study and meet the inclusion criteria will be included in the study without using any sample selection method, since it is a single-arm study. The parents of each baby will first be informed about the content of the study and will read and sign the consent form stating that they participate in the study voluntarily. Receives: Behavioral: Exercise and home program to increase lateral flexion and rotation angles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test Of Sensory Functions In Infants (TSFI)
It will be used to evaluate the sensory development of babies. The test 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: 1-12 months
Peabody Developmental Motor Scales-2
It is planned to use the Peabody Motor Development Scale-2 (PMDS-2) to evaluate motor development. It is designed to identify developmental delays in children between the ages of 0-72 months. It is used to evaluate children's motor development with separate tests and rating scales for both gross motor skills and fine motor skills.
Measured: 1-12 months
Hammersmith Infant Neurological Examination (HINE)
It is planned to be used for neurological status evaluation. It is a neurological examination consisting of 3 separate parts, standardized for babies aged 2-24 months. It contains a total of 37 items examining neurological status, motor development and behavioral status. The test evaluates cranial nerve function, movements, reflexes, posture and tonus, motor development stages, social orientation, emotional state and alertness. Total score varies between 0-78 points. A higher score indicates that the baby's condition is better.
Measured: 1-12 months
Arthrodial protractor
It is planned to use an arthrodial protractor to determine the lateral flexion and rotation range of motion of the neck.
Measured: 1-12 months
Secondary outcomes (1)
Infant/Toddler Sensory Profile
Infant/Toddler Sensory Profile; It will be used to evaluate sensory development. It is a questionnaire completed by the child's primary caregiver to collect information about sensory processing abilities. It is a questionnaire that questions the behavior and performance of a child between the ages of 0-3 (0-7 months and 7-36 months) regarding sensory processing. The test evaluates sensory processing in 6 different areas. These items; It consists of general, visual, auditory, vestibular, tactile and oral sensory processing. The caregiver evaluates the child's behavior on a 5-point scale. A score of one means "almost always" and a score of five means "almost never". The test score is evaluated in four test-specific groups: sensory sensitivity, sensory seeking, sensory avoidance, and low register.
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 posted26 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Mar 2024 (estimated)
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.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinem Erturan, Gazi University
- Investigators
- Sinem ERTURAN, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225934
- Sponsor's protocol ID
- muscular torticollis
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stellwagen L, Hubbard E, Chambers C, Jones KL. Torticollis, facial asymmetry and plagiocephaly in normal newborns. Arch Dis Child. 2008 Oct;93(10):827-31. doi: 10.1136/adc.2007.124123. Epub 2008 Apr 1.
PubMed 18381343Aarnivala HE, Valkama AM, Pirttiniemi PM. Cranial shape, size and cervical motion in normal newborns. Early Hum Dev. 2014 Aug;90(8):425-30. doi: 10.1016/j.earlhumdev.2014.05.007. Epub 2014 Jun 13.
PubMed 24951081Sargent 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 31350358Hardgrib N, Rahbek O, Moller-Madsen B, Maimburg RD. Do obstetric risk factors truly influence the etiopathogenesis of congenital muscular torticollis? J Orthop Traumatol. 2017 Dec;18(4):359-364. doi: 10.1007/s10195-017-0461-z. Epub 2017 Jun 29.
PubMed 28664414
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Home Exercise Programs Applied in Cooperation With the Family on the Treatment of Congenital Muscular Torticollis.
- ClinicalTrials.gov ID
- NCT06225934
- Acronym / sponsor ID
- muscular torticollis
- Conditions
- Congenital Muscular Torticollis, Family Members
- Keywords
- Cooperation with the family, Congenital Muscular Torticollis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 26 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 the third most common musculoskeletal disorder of infancy, affecting 3.9% to 16% of infants. It develops due to unilateral shortening of the SCM, whether or not there is a mass in the sternocleidomastoid muscle (SCM). CMT is characterized by lateral flexion of the affected SCM to the ipsilateral side and rotation to the contralateral side. Its etiology is not fully known. However, it can be associated with SCM disorder that develops due to birth trauma, prenatal/perinatal compartment syndrome and intrauterine restriction. It has been reported that conditions such as multiple pregnancy, intrauterine stenosis, vascular causes, fibrosis of the peripartum bleeding area, use of forceps at birth, difficult birth, and primary myopathy of SCM increase the possibility of CMT. It is necessary to approach babies diagnosed with CMT with an effective treatment program. The most important and effective of these approaches is to provide the necessary education and an intensive home program to their families, with whom they spend most of their days. By educating the family, on the one hand, the baby will receive regular treatment and the family's communication with the baby will be strengthened, while on the other hand, limitations such as transportation, time and cost will be eliminated. In our study; It was aimed to examine the effectiveness of the home program given in cooperation with the family in babies diagnosed with CMT and to create a new protocol.
Detailed description
Congenital muscular torticollis (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, whether or not there is a mass in the sternocleidomastoid muscle (SCM). CMT is characterized by lateral flexion of the affected SCM to the ipsilateral side and rotation to the contralateral side. Its etiology is not fully known. However, it can be associated with SCM disorder that develops due to birth trauma, prenatal/perinatal compartment syndrome and intrauterine restriction. It has been reported that conditions such as multiple pregnancy, intrauterine stenosis, vascular causes, fibrosis of the peripartum bleeding area, use of forceps at birth, difficult birth, and primary myopathy of SCM increase the possibility of CMT. These conditions cause degeneration of SCM fibers, edema in SCM, and fibrosis, as well as the general posture seen in SCM. Although CMT seems to be a condition that only concerns the neck muscles; In later periods, it may cause permanent disorders in body biomechanics such as asymmetry in the use of the upper extremities, delay in gross motor functions, postural disorders such as plagiocephaly and scoliosis, and balance disorders. Therefore, babies diagnosed with CMT should be included in a comprehensive and regular physiotherapy and rehabilitation program from the early period. These programs generally include joint range of motion-stretching exercises for the neck, family education including teaching the principles of holding and carrying, approaches such as microcurrent applications and taping, and in more severe cases, botulinum toxin-A (BOTOX-A) or surgical applications. It is necessary to approach babies diagnosed with CMT with an effective treatment program. The most important and effective of these approaches is to provide the necessary education and an intensive home program to their families, with whom they spend most of their days. By educating the family, on the one hand, the baby will receive regular treatment and the family's communication with the baby will be strengthened, while on the other hand, limitations such as transportation, time and cost will be eliminated. In our study; It was aimed to examine the effectiveness of the home program given in cooperation with the family in babies diagnosed with CMT and to create a new protocol.
In our study; It is aimed to examine the effect of the home program given to babies diagnosed with Congenital Muscular Torticollis (CMT) between the ages of 0-12 months, in cooperation with the family, on the treatment of CMT and to contribute to the literature with this approach that can be used by clinicians by creating a treatment protocol for this.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| congenital muscular torticollis | – | Behavioral: Exercise and home program to increase lateral flexion and rotation anglesBabies diagnosed with congenital muscular torticollis (CMT) who agree to participate in the study and meet the inclusion criteria will be included in the study without using any sample selection method, since it is a single-arm study. The parents of each baby will first be informed about the content of the study and will read and sign the consent form stating that they participate in the study voluntarily. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Fifteen babies diagnosed with congenital muscular torticollis (CMT) who are between 0-12 months old and agree to participate in the study will be included in the study. Congenital muscular torticollis (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 sternocleidomastoid muscle (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)
- Babies aged 0-12 months with a diagnosis of congenital muscular torticollis (CMT)
- Families who agree to participate in the study will be included in the exercise program
Key exclusion criteria (5 listed)
- Those who have any neurological risk factors were included in the study,
- Those who are affected by their visual/hearing senses,
- Those who have not been diagnosed with Congenital muscular torticollis (CMT) by a doctor,
- Those who have previously received treatment for the diagnosis of CMT,
- Babies with a history of BOTOX-A/surgery applied to the Sternocleidomastoid (SKM) muscle before treatment will not be included.
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 |
|---|---|---|
| Exercise and home program to increase lateral flexion and rotation anglesSuggestions will be made to the parent/caregiver of the baby diagnosed with congenital muscular torticollis (CMT) participating in the study to increase the baby's decreasing lateral flexion and rotation angles, and parents/caregivers will be advised to integrate these suggestions into their daily routine as much as possible.These suggestions; It includes holding-carrying-breastfeeding (feeding) principles, active-passive lateral flexion and active stretching of the child and activities that will increase joint range of motion for the SCM muscle, environmental arrangements, games that enable the development of active symmetrical movements and prone activities. The home program to be implemented by parents/caregivers will continue for 6 weeks. During the evaluations, the demographic characteristics of the babies (gender, gestational age, birth weight, parental information, mother's pregnancy type, pregnancy history, Apgar score, ultrasonography values, etc.) will be recorded. | Behavioural | congenital muscular torticollis |
Primary outcome
Test Of Sensory Functions In Infants (TSFI)
Time frame: 1-12 months
It will be used to evaluate the sensory development of babies. The test 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.
Peabody Developmental Motor Scales-2
Time frame: 1-12 months
It is planned to use the Peabody Motor Development Scale-2 (PMDS-2) to evaluate motor development. It is designed to identify developmental delays in children between the ages of 0-72 months. It is used to evaluate children's motor development with separate tests and rating scales for both gross motor skills and fine motor skills.
Hammersmith Infant Neurological Examination (HINE)
Time frame: 1-12 months
It is planned to be used for neurological status evaluation. It is a neurological examination consisting of 3 separate parts, standardized for babies aged 2-24 months. It contains a total of 37 items examining neurological status, motor development and behavioral status. The test evaluates cranial nerve function, movements, reflexes, posture and tonus, motor development stages, social orientation, emotional state and alertness. Total score varies between 0-78 points. A higher score indicates that the baby's condition is better.
Arthrodial protractor
Time frame: 1-12 months
It is planned to use an arthrodial protractor to determine the lateral flexion and rotation range of motion of the neck.
1 secondary outcome
Infant/Toddler Sensory Profile
Time frame: 1-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Results publication: PubMed 18381343Stellwagen L, Hubbard E, Chambers C, Jones KL. Torticollis, facial asymmetry and plagiocephaly in normal newborns. Arch Dis Child. 2008 Oct;93(10):827-31. doi: 10.1136/adc.2007.124123. Epub 2008 Apr 1.
- Results publication: PubMed 24951081Aarnivala HE, Valkama AM, Pirttiniemi PM. Cranial shape, size and cervical motion in normal newborns. Early Hum Dev. 2014 Aug;90(8):425-30. doi: 10.1016/j.earlhumdev.2014.05.007. Epub 2014 Jun 13.
- 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 28664414Hardgrib N, Rahbek O, Moller-Madsen B, Maimburg RD. Do obstetric risk factors truly influence the etiopathogenesis of congenital muscular torticollis? J Orthop Traumatol. 2017 Dec;18(4):359-364. doi: 10.1007/s10195-017-0461-z. Epub 2017 Jun 29.
- 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.
Sinem ERTURAN principal investigator
Study Principal Investigator
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 Family Members, 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 5 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: status not confirmed, as of the sponsor's last update on 26 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sinem ERTURAN (+905388557084, snm.ertrn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test Of Sensory Functions In Infants (TSFI) (time frame: 1-12 months). The study lists 4 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 NCT06225934, 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 26 Jan 2024.