Postural Assessment in Plagiocephaly

November 1, 2016 updated by: Marie Carmen Valenza, Universidad de Granada

Postural Assessment in Children With Non-synostotic 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain, 18071
        • Department of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who were diagnosed by plagiocephaly and a control group.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
The posture, motor development and balance are going to be assessed.
Other Names:
  • Evaluation
  • Posture assessment
  • Psychomotor development

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
baseline
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.
baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

Investigators

  • Principal Investigator: Irene Cabrera Martos, MsC, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 20, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DF0043UG
  • AP2010-3603 (OTHER_GRANT: Ministry of Education, Spain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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