Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

NCT ID: NCT03430739

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-05

Study Completion Date

2019-07-05

Brief Summary

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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

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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.

Conditions

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Non Synostotic Plagiocephaly

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Babies; Usage time of Helmet between 15-18 hours a day

Babies who worn the helmet for 15-18 hours a day

No intervention

Intervention Type OTHER

No intervention

Babies; Usage time of Helmet between 19-23 hours a day

Babies who worn the helmet for 19-23 hours a day

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

have another systemic, neurologic or orthopedic problem
Minimum Eligible Age

1 Day

Maximum Eligible Age

7 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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hhotaman

PhD, Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Trakya University

Edirne, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Facility Contacts

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Hilal Keklicek

Role: primary

5447208798

Other Identifiers

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GO 10-76

Identifier Type: -

Identifier Source: org_study_id

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