Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

February 6, 2018 updated by: hhotaman, Hacettepe University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Edirne, Turkey, 22030
        • Trakya University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Babies using helmet due to deformational plagiocephaly.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
plagiocephaly severity scale
Time Frame: 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
Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemispheric asymmetry
Time Frame: 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)
Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 5, 2018

Primary Completion (Anticipated)

June 5, 2019

Study Completion (Anticipated)

July 5, 2019

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 10-76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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