Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

• Conditions: Non Synostotic Plagiocephaly
• Interventions: Other: No intervention

• Registration Number: NCT03430739
• Lead Sponsor: Hacettepe University

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.

Study Timeline

• Status Verified: 2018-02
• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-06
• Last Update Submitted: 2018-02-06
• Study First Posted: 2018-02-13
• Last Update Posted: 2018-02-13
• Study Start: 2018-06-05
• Primary Completion: 2019-06-05
• Study Completion: 2019-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

Exclusion Criteria

have another systemic, neurologic or orthopedic problem

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Babies; Usage time of Helmet between 15-18 hours a day	No intervention	Babies who worn the helmet for 15-18 hours a day
Babies; Usage time of Helmet between 19-23 hours a day	No intervention	Babies who worn the helmet for 19-23 hours a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Trakya University; 🇹🇷 Edirne, Turkey