A Randomized Controlled Study in the Efficiency of Soft Tissue Mobilization in Babies With Congenital Muscular Torticollis and Deformational Plagiocephaly
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hacettepe University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Head tilt with photographic method
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Soft tissue mobilization group
soft tissue mobilization was applied three times in a week and home program exercises were recommended which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations
Intervention: soft tissue mobilization (Other)
Home program controlled once six weeks
Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations were recommended
Intervention: home program controlled once six weeks (Other)
Outcomes
Primary Outcomes
Head tilt with photographic method
Time Frame: Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Baby lies supine while taking photo of baby's habitual head position. The angle between the two lines, connecting eyes pupils and connecting acromions, is assessed.
plagiocephaly severity scale
Time Frame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.
Secondary Outcomes
- Passive range of motion(Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks)
Investigators
hhotaman
Research Assistant, PhD, PT
Hacettepe University