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Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

NCT03430739 — Unknown, 28 participants, Hacettepe University

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

RegistryNCT03430739
StatusUnknown
Study typeObservational
Enrollment28 (Estimated)
SponsorHacettepe University (Other)
ConditionsNon Synostotic Plagiocephaly
InterventionsNo intervention (Other)
Datesstart 2018-06-05 (estimated), primary completion 2019-06-05 (estimated), completion 2019-07-05 (estimated), first posted 2018-02-13, last updated 2018-02-13
Locations1 site in Turkey (Türkiye)

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Babies; Usage time of Helmet between 15-18 hours a dayOther: No interventionBabies who worn the helmet for 15-18 hours a day
Babies; Usage time of Helmet between 19-23 hours a dayOther: No interventionBabies who worn the helmet for 19-23 hours a day
  • No intervention (Other): No intervention

+Outcome measures

Primary outcomes

  • plagiocephaly severity scale [Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks]: scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry

Secondary outcomes

  • Hemispheric asymmetry [Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks]: Difference between the right and left hemisphere of head (centimeter)

+Eligibility

Sex: All, ages: 1 Day to 7 Months

Inclusion Criteria:

have deformational plagiocephaly consent from caregivers age between 1 day to 7 months

Exclusion Criteria:

have another systemic, neurologic or orthopedic problem

+Locations (1)

FacilityCityCountryStatus
Trakya UniversityEdirneTurkey (Türkiye)

My Notes