The Effect of Home Exercise Programs Applied of Congenital Muscular Torticollis.

NCT ID: NCT06225934

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-03-15

Brief Summary

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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

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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

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Congenital Muscular Torticollis Family Members

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Exercise and home program to increase lateral flexion and rotation angles

Intervention Type BEHAVIORAL

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.

Interventions

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Exercise and home program to increase lateral flexion and rotation angles

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Sinem Erturan

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sinem ERTURAN

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Rabia ZORLULAR

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Sinem ERTURAN

Role: CONTACT

+905388557084

Rabia ZORLULAR

Role: CONTACT

+905424362082

Facility Contacts

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Rabia ZORLULAR

Role: primary

+905424362082

References

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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.

Reference Type RESULT
PMID: 18381343 (View on PubMed)

Aarnivala 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.

Reference Type RESULT
PMID: 24951081 (View on PubMed)

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.

Reference Type RESULT
PMID: 31350358 (View on PubMed)

Hardgrib 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.

Reference Type RESULT
PMID: 28664414 (View on PubMed)

Other Identifiers

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muscular torticollis

Identifier Type: -

Identifier Source: org_study_id

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