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Clinical Trials/NCT06294626
NCT06294626
Completed
N/A

Examination of Neuromotor Development of Cases Diagnosed With Scaphocephaly

Acıbadem Atunizade Hospital1 site in 1 country21 target enrollmentJanuary 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Craniosynostosis, Sagittal
Sponsor
Acıbadem Atunizade Hospital
Enrollment
21
Locations
1
Primary Endpoint
Denver-II Developmental Screening Test
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Scaphocephaly (sagittal synostosis) is the most common single-suture craniosynostosis. It occurs as a result of premature ossification of the fibrous connective tissue extending between two parietal bones (sagittal suture). Phenotypically, a long and narrow head shape occurs. It occurs in 2-3 per 10,000 live births and is more common in men. Premature ossification of the sagittal suture can lead to cranial deformity, potentially cranial growth restriction, and resulting increased intracranial pressure. In these cases, increased intracranial pressure and compression of the sagittal sinus cause increased venous pressure, which may cause developmental delays. These delays most commonly include cognitive impairments, language disorders, motor delays, learning disabilities, executive dysfunction, and behavioral problems. When looking at the literature, it was seen that the studies were mostly on neurocognitive development in cases with craniosynostosis. There are relatively fewer studies focusing on the neuromotor development of these cases. This study aims to evaluate the neuromotor development of scaphocephaly cases.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Acıbadem Atunizade Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ilayda Sozeri

Pediatric Physiotherapist

Acıbadem Atunizade Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Denver-II Developmental Screening Test

Time Frame: baseline

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.

Alberta Infant Motor Scale

Time Frame: baseline

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.

Study Sites (1)

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