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
-
-
-
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
|
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
|
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
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
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.