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Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

H

Hacettepe University

Status

Unknown

Conditions

Non Synostotic Plagiocephaly

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03430739
GO 10-76

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 estimated patients

Sex

All

Ages

1 day to 7 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

have another systemic, neurologic or orthopedic problem

Trial design

28 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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