NCT01989286

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

November 14, 2013

Last Update Submit

November 1, 2016

Conditions

Keywords

PlagiocephalyPostureSpine

Outcome Measures

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.

    baseline

Secondary Outcomes (3)

  • Postural evaluation

    baseline

  • Psychomotor assessment

    baseline

  • Balance

    baseline

Other Outcomes (1)

  • Quality of sleep

    baseline

Study Arms (1)

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

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

Also known as: Evaluation, Posture assessment, Psychomotor development
Plagiocephaly group-Assessment

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who were diagnosed by plagiocephaly and a control group.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, Spain, 18071, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27329908BACKGROUND

MeSH Terms

Conditions

Plagiocephaly

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Irene Cabrera Martos, MsC

    Universidad de Granada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 20, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations