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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06216379
Other study ID # E-77082166-604.01.02-739050
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 1, 2023

Study information

Verified date January 2024
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the study, sensory processing skills of 1-year-old preterm and term children will be evaluated. The relationship between sensory processing skills and gross and fine motor development will be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers
Gender All
Age group 12 Months to 12 Months
Eligibility Inclusion Criteria: Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks Exclusion Criteria: they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

Study Design


Intervention

Diagnostic Test:
Assessment
Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated.

Locations

Country Name City State
Turkey Erzurum Technical University Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Test of Sensory Functions in Infants TSFI The Test of Sensory Functions in Infants (TSFI) is a standardized and reliable tool designed to evaluate the sensory development of infants aged 4-18 months. Consisting of 24 items, the TSFI measures reactions in five distinct subdomains: tactile deep pressure, visual-tactile integration, adaptive motor function, ocular motor function, and reactivity to vestibular stimulation [1]. A specific age-normalized score is generated for each subdomain, contributing to a total score determined by the sum of all subdomains. The total score ranges from 0 to 49, with higher scores indicating more typical sensory responsiveness and lower scores suggesting behaviors associated with sensory over-responsivity [2]. In this study, a physiotherapist administered the TSFI to assess the sensory development of infants. 15 minutes
Secondary Peabody Developmental Motor Scales-2 The PDMS-2 is a widely employed and acknowledged assessment tool for evaluating a child's motor abilities. Its primary purpose is to distinguish and aid in identifying developmental delays in children aged 5 and below by comparing their performance against established norms [3]. The gross motor skills section includes 4 subtests: reflexes, stationary, locomotion, and object manipulation. Similarly, the fine motor skills segment consists of 2 subtests: grasping and visual-motor integration. Each item in the test is evaluated using a 3-point scoring system. 30 minutes
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