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Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03430739
Enrollment
28
Registered
2018-02-13
Start date
2018-06-05
Completion date
2019-07-05
Last updated
2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Synostotic Plagiocephaly

Keywords

Deformational Plagiocephaly, Orthotics, Helmet

Brief 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.

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 7 Months
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

have another systemic, neurologic or orthopedic problem

Design outcomes

Primary

MeasureTime frameDescription
plagiocephaly severity scaleChange from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeksscale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry

Secondary

MeasureTime frameDescription
Hemispheric asymmetryChange from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeksDifference between the right and left hemisphere of head (centimeter)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026