PlagiocephalyNCT01989286
Postural Assessment in Plagiocephaly
An observational study of Plagiocephaly, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Plagiocephaly
- What is being tested?
- Assessment
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who were diagnosed by plagiocephaly and a control group.
Who may be able to join
- Diagnosis of infant positional plagiocephaly
- Aged 3, 4 or 5 years old.
Who cannot join
- Diagnosis of non synostotic plagiocephaly.
- Neurological concomitant condition.
- Problems in motor development.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Plagiocephaly
- Being tested
- Assessment
- Keywords
- Plagiocephaly, Posture, Spine
- Medical subject headings
- Plagiocephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Also called Evaluation, Posture assessment, Psychomotor development
The posture, motor development and balance are going to be assessed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (3)
Postural evaluation
The postural assessment comprises the static posture and the spinal flexibility by observing different positions and actions of the children.
Measured: baseline
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.
Measured: baseline
Balance
The balance is assessed with the Pediatric Balance Test, asking the children to perform different tasks and observing the execution of these tasks.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Irene Cabrera Martos, MsC, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989286
- Sponsor's protocol ID
- DF0043UG
- Other IDs
- AP2010-3603
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Assessment in Children With Non-synostotic Plagiocephaly
- ClinicalTrials.gov ID
- NCT01989286
- Acronym / sponsor ID
- DF0043UG
- Conditions
- Plagiocephaly
- Keywords
- Plagiocephaly, Posture, Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plagiocephaly group-Assessment | – | Other: AssessmentChildren (3-5 years) who were diagnosed and treated because of positional plagiocephaly are included in this group. An asssessment of posture will be performed. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who were diagnosed by plagiocephaly and a control group.
Key inclusion criteria (2 listed)
- Diagnosis of infant positional plagiocephaly
- Aged 3, 4 or 5 years old.
Key exclusion criteria (3 listed)
- Diagnosis of non synostotic plagiocephaly.
- Neurological concomitant condition.
- Problems in motor development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAlso: Evaluation, Posture assessment, Psychomotor developmentThe posture, motor development and balance are going to be assessed. | Other | Plagiocephaly group-Assessment |
Primary outcome
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.
3 secondary outcomes
Postural evaluation
Time frame: baseline
Psychomotor assessment
Time frame: baseline
Balance
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Background: PubMed 27329908Cabrera-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.
- Individual participant dataSharing planned: Undecided
Related trials for Plagiocephaly
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Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Premature Newborns, Cranial Asymmetry
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Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Not yet recruitingObservational study
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
Plagiocephaly, Nonsynostotic, Brachycephaly
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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene Cabrera Martos, MsC principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plagiocephaly, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spine assessment (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.