Investigating the Effectiveness of Control Frequency on and Deformational Plagiocephaly
NCT ID: NCT02607969
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2015-11-30
2016-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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seen once every six weeks
Parents will be educated about home program and they will be asked to control once every six weeks.
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
seen once a week.
Parents will be educated about home program and they will be asked to control once a week.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Head tilt from 5 to 20 degrees
* Age between 0-6 months
Exclusion Criteria
1 Month
6 Months
ALL
No
Sponsors
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Hacettepe University
OTHER
Responsible Party
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hhotaman
PhD, PT
Principal Investigators
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Hilal KEKLİCEK, PhD, PT
Role: PRINCIPAL_INVESTIGATOR
Hacettepe University,Faculty of Health Sciences Department of Physiotherapy
Central Contacts
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Other Identifiers
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G014/15
Identifier Type: -
Identifier Source: org_study_id