Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

Study Overview
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Brief Summary
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Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months.

Detailed Description
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Investigating the optimal usage time of helmet therapy is the aim of the study. Participants will be babies with deformational plagiocephaly. Plagiocephalometric assesments will be utilize to follow improvement of head symmetry. Scales asking sensational integration and severity of plagiocephaly will also be used. Time of daily usage will be follow with daily asking the caregivers how long the baby wear the helmet in a day. Participants will follow for three months. After the follow period completed, participants will be allocated two groups; avarage using 15-18 hours a day and avarage using 19-23 hours a day. Results will be compared for the two groups and correlation between the time of usage and cranial symmetry will be compare.

Official Title
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Investigating the Optimal Usage Time of Helmet in Babies With Deformational Plagiocephaly

Conditions
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Non Synostotic Plagiocephaly

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have deformational plagiocephaly consent from caregivers age between 1 day to 7 months Exclusion Criteria: have another systemic, neurologic or orthopedic problem

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Babies; Usage time of Helmet between 15-18 hours a day<br>Babies who worn the helmet for 15-18 hours a day | Other: No intervention<br>* No intervention<br>|
| Babies; Usage time of Helmet between 19-23 hours a day<br>Babies who worn the helmet for 19-23 hours a day | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemispheric asymmetry | Difference between the right and left hemisphere of head (centimeter) | Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deformational Plagiocephaly, Orthotics, Helmet