Deformational Plagiocephaly Clinical Trial
Official title:
Comparison the Effectiveness Control Frequency of Physiotherapy Home Program on Deformational Plagiocephaly
30 babies with Deformational Plagiocephaly (DP) due to the congenital muscular torticollis
will be the participants of the study.
The subjects will randomly allocated into the two home program groups; first home program
group was seen once every six weeks (SxW), second home program group was seen once a week
(OW).
Parents will educate about the same home program which consisted of positioning the neck and
head, sleep in alternating head positions and in side-laying to increase head shape symmetry
and place infants, when awake and under supervision, regularly in the prone position a day
to stimulate normal motor development (tummy time), decreasing the time spent in car seat at
supine position. Environmental settings also will be given to challenge the baby look
through from the side no flattening to room, place colorful and sonorous toys or mirror on
the opposite of the flattening side, and stimulate active rotation by communicating with
baby from this side. Handling strategies, stretching and strengthening exercises will be
given for CMT. The parents will be reinforme if necessary. Positioning strategies will
spread throughout the day.Plagiocephaly severity assessment scale (PSS) which has 5
subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial
asymmetry, ear asymmetry will be used to evaluate severity of DP.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | November 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 6 Months |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | plagiocephaly severity scale | scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry. | Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks | Yes |
Secondary | 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. | Change from Baseline in head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks | Yes |
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Recruiting |
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