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CompletedNCT01989286Updated Nov 2, 2016

Postural Assessment in Plagiocephaly

An observational study in Plagiocephaly, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 3 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Universidad de Granada · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
104
Ages
3 Years to 5 Years
Sex
All
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Study summary

The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of this study is to evaluate the spine, the posture and the psychomotor state in children who were diagnosed with infant plagiocephaly.

Read the detailed description

Positional infant plagiocephaly is a clinical entity in which the shape of an infant's head becomes altered as the result of external forces applied to the malleable bones of the cranium and can occur pre- or postnatally. It is characterized by asymmetric occipital flattening (one side or the central part of the occiput is flattened)with ipsilateral frontal bossing.Viewed from above, this results in a parallelogram deformity of the head. We hypothesize that children who had plagiocephaly when they were infants, they have postural and spine implications at 3-5 years old.

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Conditions studied

  • Plagiocephaly

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Keywords

  • Plagiocephaly
  • Posture
  • Spine
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In context

Plagiocephaly

16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.

Browse Plagiocephaly studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 246 studies on the registry; 43 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Children who were diagnosed by plagiocephaly and a control group.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of infant positional plagiocephaly
  • Aged 3, 4 or 5 years old.

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of non synostotic plagiocephaly.
  • Neurological concomitant condition.
  • Problems in motor development.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
104 participants (actual)
Patient registry
No

Groups and cohorts

  • Plagiocephaly group-Assessment

    Children (3-5 years) who were diagnosed and treated because of positional plagiocephaly are included in this group. An asssessment of posture will be performed.

    Other: Assessment

Interventions

  • OtherAssessment

    The posture, motor development and balance are going to be assessed.

    Also known as: Evaluation, Posture assessment, Psychomotor development

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What researchers measure

Primary outcomes

  1. Spine assessment

    The spine alignment, segmental and global angles in the sagittal and frontal planes,and the spinal mobility are going to be assessed by the Spinal Mouse®,a device guided manually on the skin along the spine.

    Time frame: baseline

Secondary outcomes

  1. Postural evaluation

    The postural assessment comprises the static posture and the spinal flexibility by observing different positions and actions of the children.

    Time frame: baseline

  2. Psychomotor assessment

    The psychomotor development test, TEPSI, is going to be used to assess three areas: coordination, language and motor state. The children are asked to perform different activities and the success is registered.

    Time frame: baseline

  3. Balance

    The balance is assessed with the Pediatric Balance Test, asking the children to perform different tasks and observing the execution of these tasks.

    Time frame: baseline

Other outcomes

  1. Quality of sleep

    The parents are going to complete the Pediatric Sleep Questionnaire, with different items evaluating the quality of sleep of the children.

    Time frame: baseline

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Study locations

1 site
  • Department of Physical Therapy
    Granada, 18071, Spain
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References and documents

Publications

  • Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benitez-Feliponi A, Robles-Vizcaino C, Ruiz-Extremera A. Repercussions of plagiocephaly on posture, muscle flexibility and balance in children aged 3-5 years old. J Paediatr Child Health. 2016 May;52(5):541-6. doi: 10.1111/jpc.13155. PubMed 27329908 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01989286
Responsible party
Marie Carmen Valenza (assistant professor, Universidad de Granada) — Principal investigator
First posted
Nov 20, 2013
Start date
Nov 2013
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Nov 2, 2016

Study contacts

Irene Cabrera Martos, MsC
principal investigator · Universidad de Granada

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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