NCT06294626

Brief Summary

It's an observational study. Purpose of the study: To evaluate the neuromotor development of scaphocephaly cases. 21 infants diagnosed with scaphocephaly aged 2-17 months were included.

  • Is there any delay in the neuromotor development of scaphocephaly cases?
  • If delay is observed, in which area is it most common? Denver-II Developmental Screening Test and Alberta Motor Infant Scale were applied to the participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

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

January 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 years

First QC Date

February 28, 2024

Last Update Submit

September 5, 2024

Conditions

Keywords

scaphocephalyneuromotor developmentalberta infant motor scaledenver II developmental screening testpediatric rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Denver-II Developmental Screening Test

    It's a screening test used in children aged 0-6 years. The test is done in a short time like 5-20 min. The person who will administer the Denver-II test; must be trained and certified. Standardized test materials are used. The test consists of 4 sections and 134 items. There are personal-social, language, fine motor and gross motor sections. The test result is classified as Normal-Abnormal-Suspicious.

    baseline

  • Alberta Infant Motor Scale

    It's used to observe gross motor functions and evaluate the effectiveness of the intervention in typically developing infants between 0-18 months. The duration of the test is 10 min and consists of 58 items. The child's spontaneous movements are evaluated in 4 different positions without touching the child. 1 point is taken for each item that can be done. A table containing the mean and standard deviation for each month is used. The test result is classified as Normal-Abnormal-Suspicious.

    baseline

Study Arms (1)

Examination of neuromotor development of cases diagnosed with scaphocephaly

21 cases with scaphocephaly were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale.

Other: Group 1

Interventions

Group 1OTHER

21 cases with scaphocephaly diagnoses were included. Neuromotor development was evaluated with the Denver-II Developmental Screening Test and Alberta Infant Motor Scale.

Examination of neuromotor development of cases diagnosed with scaphocephaly

Eligibility Criteria

Age2 Months - 17 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

21 cases diagnosed with scaphocephaly aged 2-17 monts were included.

You may qualify if:

  • Having been diagnosed with scaphocephaly
  • Being between 0-18 months

You may not qualify if:

  • Be over 18 months
  • Having a diagnosed disease other than scaphocephaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Altunizade Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

CraniosynostosesLearning Disabilities

Condition Hierarchy (Ancestors)

SynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Physiotherapist

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 5, 2024

Study Start

January 1, 2019

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be made available to other researchers.

Locations