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Completed

NCT Number: NCT01989286

Postural Assessment in Plagiocephaly

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.

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Key information

Conditions

Plagiocephaly Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Physical Therapy

Granada, Spain, 18071

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Assessment

Other

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

Other names: Evaluation, Posture assessment, Psychomotor development

Primary outcomes

  1. Spine assessment

    Time frame: baseline

    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.

Secondary outcomes

  1. Postural evaluation

    Time frame: baseline

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

  2. Psychomotor assessment

    Time frame: baseline

    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.

  3. Balance

    Time frame: baseline

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

Other outcomes

  1. Quality of sleep

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Postural Assessment in Children With Non-synostotic Plagiocephaly

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 20, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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