Clinical trial NCT06225934: The Effect of Home Exercise Programs Applied of Congenital Muscular Torticollis.
Official title: The Effect of Home Exercise Programs Applied in Cooperation With the Family on the Treatment of Congenital Muscular Torticollis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Muscular Torticollis
Family Members
Keywords: Cooperation with the family
Congenital Muscular Torticollis
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Test Of Sensory Functions In Infants (TSFI)
timeFrame: 1-12 months
measure: Peabody Developmental Motor Scales-2
timeFrame: 1-12 months
measure: Hammersmith Infant Neurological Examination (HINE)
timeFrame: 1-12 months
measure: Arthrodial protractor
timeFrame: 1-12 months
Secondary outcomes:
measure: Infant/Toddler Sensory Profile
timeFrame: 1-12 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Rabia ZORLULAR
Study officials:
affiliation: Study Principal Investigator
name: Sinem ERTURAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.