NCT03430739

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2019

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 6, 2018

Last Update Submit

February 6, 2018

Conditions

Non Synostotic Plagiocephaly

Keywords

Deformational Plagiocephaly, Orthotics, Helmet

Outcome Measures

Primary Outcomes (1)

  • plagiocephaly severity scale

    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 Outcomes (1)

  • Hemispheric asymmetry

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

Study Arms (2)

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

No interventionOTHER

No intervention

Babies; Usage time of Helmet between 15-18 hours a dayBabies; Usage time of Helmet between 19-23 hours a day

Eligibility Criteria

Age1 Day - 7 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Babies using helmet due to deformational plagiocephaly.

You may qualify if:

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

You may not qualify if:

  • have another systemic, neurologic or orthopedic problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic

Condition Hierarchy (Ancestors)

PlagiocephalyCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assoc Prof

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 13, 2018

Study Start

June 5, 2018

Primary Completion

June 5, 2019

Study Completion

July 5, 2019

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

TU(1)