Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

Non Synostotic Plagiocephaly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03430739
• Other study ID #: GO 10-76
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2018
• Last updated: February 6, 2018
• Start date: June 5, 2018
• Est. completion date: July 5, 2019

Study information

• Verified date: February 2018
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: July 5, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

have another systemic, neurologic or orthopedic problem

Related Conditions & MeSH terms

• Non Synostotic Plagiocephaly
• Plagiocephaly
• Plagiocephaly, Nonsynostotic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Turkey	Trakya University	Edirne

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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