Clinical trial NCT02403011: Investigating the Effectiveness of Mobilization on Congenital Muscular Torticollis and Deformational Plagiocephaly
Official title: A Randomized Controlled Study in the Efficiency of Soft Tissue Mobilization in Babies With Congenital Muscular Torticollis and Deformational Plagiocephaly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Muscular Torticollis
Keywords: Congenital Muscular Torticollis
Manual Therapy
Infant
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of soft tissue mobilization in babies with neck muscle problem. Babies received soft tissue mobilization or home exercises program

Detailed description: Objectives: Investigating the effectiveness of soft tissue mobilization in babies with congenital muscular torticollis and deformational plagiocephaly.

Design: A Randomized controlled trial design Setting: University research department Participants:Babies with congenital muscular torticollis, aged between 0-6 months, who had a head tilt from 5 to 20 degrees and no other health problems were the participants of the study. The study included two groups; home program group was seen once every six weeks, the study group in addition to the home program also received soft tissue mobilization three times in a week. All groups received a baseline home program consisting of positioning, handling strategies plus stretching, stretching and strengthening exercises, environmental adaptations and classical massage. Babies were allocated to two groups by sealed envelope randomization. Babies were evaluated initially, at sixth weeks, at 12 weeks and follow-up at 18 weeks with muscle function scale, head tilt and ear shift assessments which included photographing method, neck normal range of motions (lateral flexion and rotation) and plagiocephaly severity scale

Eligibility criteria: Inclusion Criteria:

* Babies with congenital muscular torticollis and secondary deformational plagiocephaly
* Head tilt from 5 to 20 degrees
* Age between 0-6 months

Exclusion Criteria:

* Have another health problem such as neurological, vertebral anomalies, craniosynostosis

Primary outcomes:
measure: Head tilt with photographic method
timeFrame: Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
measure: plagiocephaly severity scale
timeFrame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Secondary outcomes:
measure: Passive range of motion
timeFrame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: Hacettepe University,Faculty of Health Sciences Department of Physiotherapy
name: Hilal KEKLİCEK, PhD,PT
role: PRINCIPAL_INVESTIGATOR
References: