An interventional study of Home program in Deformational Plagiocephaly, sponsored by Hacettepe University. Status unknown. Open to participants aged 1 Month to 6 Months. Per ClinicalTrials.gov, last updated 2015-11-18.
Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment
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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.
30 babies with Deformational Plagiocephaly due to the congenital muscular torticollis will be the participants of the study.
The subjects will randomly allocate 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), by utilizing sealed envelope if babies met the following inclusion and exclusion criteria.
After the initial evaluation, parents will be 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 CMT. One or two days after the first visit the parents will asked to come again and demonstrate how they had implemented the home program and what adaptations they had made. The parents will be reinformed if necessary. Positioning strategies will spread throughout the day.
Participants will be allocated to the groups with sealed envelope randomization after parent will be given the same home program.
752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.
This study's planned enrollment of 30 is below the median of 116 across 527 interventional studies indexed under Patient Compliance.
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Exclusion Criteria:
Parents will be educated about home program and they will be asked to control once every six weeks.
Other: Home program
Parents will be educated about home program and they will be asked to control once a week.
Other: Home program
Parents will be educated about the 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 were 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 given for CMT
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 head tilt at 6th weeks of treatment, at the end of the treatment/12th weeks, at follow up/18th weeks
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
No study locations are listed for this record.
The record gives a start of Nov 2015, a primary completion of Mar 2016 and a completion of Nov 2016. 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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