Postural Assessment in Plagiocephaly

Plagiocephaly Clinical Trial

Official title:

Postural Assessment in Children With Non-synostotic Plagiocephaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01989286
• Other study ID #: DF0043UG
• Secondary ID: AP2010-3603
• Status: Completed
• Phase: N/A
• First received: November 14, 2013
• Last updated: November 1, 2016
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: November 2016
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Plagiocephaly

Intervention

Other:
• Assessment
The posture, motor development and balance are going to be assessed.

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Cabrera-Martos I, Valenza MC, Valenza-Demet G, Benítez-Feliponi Á, Robles-Vizcaíno C, Ruiz-Extremera Á. 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of sleep	The parents are going to complete the Pediatric Sleep Questionnaire, with different items evaluating the quality of sleep of the children.	baseline	Yes
Primary	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.	baseline	Yes
Secondary	Postural evaluation	The postural assessment comprises the static posture and the spinal flexibility by observing different positions and actions of the children.	baseline	Yes
Secondary	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.	baseline	Yes
Secondary	Balance	The balance is assessed with the Pediatric Balance Test, asking the children to perform different tasks and observing the execution of these tasks.	baseline	Yes