CClinicalTrials.gg
Status unknownNCT03430739Updated Feb 13, 2018

Effect of Usage Time of Helmet in Babies With Deformational Plagiocephaly

An observational study in Non Synostotic Plagiocephaly, sponsored by Hacettepe University. Status unknown at 1 site in Turkey. Open to participants aged 1 Day to 7 Months. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Hacettepe University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
1 Day to 7 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Non Synostotic Plagiocephaly

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Keywords

  • Deformational Plagiocephaly, Orthotics, Helmet
03

Who can participate

Ages eligible
1 Day to 7 Months
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Babies using helmet due to deformational plagiocephaly.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

have another systemic, neurologic or orthopedic problem

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherNo intervention

    No intervention

05

What researchers measure

Primary outcomes

  1. plagiocephaly severity scale

    scale which has 5 subgroups as following frontal asymmetry, occipital flattening, head tilt, fascial asymmetry, ear asymmetry

    Time frame: 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)

    Time frame: Change from Baseline in head asymmetry at 6th weeks of treatment, at the end of the treatment/12th weeks

06

Study locations

1 site
  • Trakya University
    Edirne, 22030, Turkey
    • Hilal Keklicek · Contact · hhotaman23@gmail.com · 5447208798
    • Sinem Salar, PhD · Sub investigator
    • Serkan Pekcetin, PhD · Sub investigator
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03430739
Lead sponsor
Hacettepe University
Responsible party
hhotaman (PhD, Assoc Prof, Trakya University) — Principal investigator
First posted
Feb 13, 2018
Start date
Jun 5, 2018 (estimated)
Primary completion
Jun 5, 2019 (estimated)
Completion
Jul 5, 2019 (estimated)
Last update
Feb 13, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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