Non Synostotic PlagiocephalyNCT03430739
Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly
An observational study of Non Synostotic Plagiocephaly, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 7 months
- Conditions the study is for
- Non Synostotic Plagiocephaly
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2018to 5 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 months
- All sexes
- No healthy volunteers
- Child
Study population: Babies using helmet due to deformational plagiocephaly.
Who may be able to join
- have deformational plagiocephaly consent from caregivers age between 1 day to 7 months
Who cannot join
- have another systemic, neurologic or orthopedic problem
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University
Edirne, 22030
Hilal Keklicek, 5447208798, hhotaman23@gmail.com
Sinem Salar, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Non Synostotic Plagiocephaly
- Being tested
- No intervention
- Keywords
- Deformational Plagiocephaly, Orthotics, Helmet
- Medical subject headings
- Plagiocephaly, Nonsynostotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Babies; Usage time of Helmet between 15-18 hours a day | Babies who worn the helmet for 15-18 hours a day Receives: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
plagiocephaly severity scale
scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry
Measured: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
Secondary outcomes (1)
Hemispheric asymmetry
Difference between the right and left hemisphere of head (centimeter)
Measured: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start5 Jun 2018 (estimated)
- Primary completion5 Jun 2019 (estimated)
- Study completion5 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Synostotic PlagiocephalyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hhotaman, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430739
- Sponsor's protocol ID
- GO 10-76
- Status last verified
- Feb 2018
- First submitted
- 6 Feb 2018
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Optimal Usage Time of Helmet in Babies With Deformational Plagiocephaly
- ClinicalTrials.gov ID
- NCT03430739
- Acronym / sponsor ID
- GO 10-76
- Conditions
- Non Synostotic Plagiocephaly
- Keywords
- Deformational Plagiocephaly, Orthotics, Helmet
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Jun 2018 (estimated)
- Primary completion
- 5 Jun 2019 (estimated)
- Study completion
- 5 Jul 2019 (estimated)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babies; Usage time of Helmet between 15-18 hours a day | – | Other: No interventionBabies who worn the helmet for 15-18 hours a day |
| Babies; Usage time of Helmet between 19-23 hours a day | – | Other: No interventionBabies who worn the helmet for 19-23 hours a day |
Who may qualify
- Ages
- 1 day to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Babies using helmet due to deformational plagiocephaly.
Key inclusion criteria (1 listed)
- have deformational plagiocephaly consent from caregivers age between 1 day to 7 months
Key exclusion criteria (1 listed)
- have another systemic, neurologic or orthopedic problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Babies; Usage time of Helmet between 15-18 hours a day, Babies; Usage time of Helmet between 19-23 hours a day |
Primary outcome
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
1 secondary outcome
Hemispheric asymmetry
Time frame: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Synostotic Plagiocephaly, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plagiocephaly severity scale (time frame: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2018.