An interventional study of soft tissue mobilization and home program controlled once six weeks in Congenital Muscular Torticollis, sponsored by Hacettepe University. Status unknown at 1 site in Turkey. Open to participants aged Up to 6 Months. Per ClinicalTrials.gov, last updated 2015-11-09.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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This study investigates the effect of soft tissue mobilization in babies with neck muscle problem. Babies received soft tissue mobilization or home exercises program
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
21 studies on the registry are indexed under Congenital torticollis; 4 are open to participants now.
This study's planned enrollment of 30 is close to the median of 32 across 12 interventional studies indexed under Congenital torticollis.
Browse Congenital torticollis studies →Hacettepe University is the lead sponsor of 1,009 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
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
Other: soft tissue mobilization
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
Other: home program controlled once six weeks
soft tissue mobilization technique has three phases. First phase 'the passive mobilization phase' is applied by gentle but tight gripping of the SKM muscle two or three fingers below the muscle origo and the muscle is mobilized rhythmically in the antero-posterior direction. Secondly, after gently continue to hold the muscle the baby was encouraged to do active repetitive cervical rotation to the affected side by means of catching the babies attention with colored and sonorous toys. Third phase was mobilization with stretching. Caregiver holds the baby on his/ her affected side while the therapist gently grips and withholds the muscle. Therapist mobilizes the muscle in the antero-posterior direction and stretch the muscle
Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations
Head tilt with photographic method
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.
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
plagiocephaly severity scale
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry.
Time frame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
Passive range of motion
Baby lies in supine position and caregiver holds the baby's upper extremities by stabilizing shoulders to prevent compansatuar movements. For lateral flexion therapist bends the neck to opposite side from affected SCM. For neck rotation, therapist rotate the neck to affected SCM.
Time frame: Change from Baseline in at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
The record gives a start of Jan 2014, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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