CClinicalTrials.gg
CompletedNCT06216379Updated Jan 22, 2024

Sensory Processing Associated With Motor Skills

An observational study in Preterm Birth, Sensory Processing Disorder and Motor Delay, sponsored by Gazi University. Completed at 1 site in Turkey. Open to participants aged 12 Months to 12 Months. Per ClinicalTrials.gov, last updated 2024-01-22.

Sponsored by Gazi University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
61
Ages
12 Months to 12 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Preterm Birth
  • Sensory Processing Disorder
  • Motor Delay

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03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 61 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 12 Months
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy children born preterm and term at 12 months of age

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

Exclusion Criteria:

they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
61 participants (actual)
Patient registry
No

Groups and cohorts

  • Preterm

    Children born before 37 gestational weeks

    Diagnostic Test: Assessment

  • Term

    Children born after 37 weeks of gestation

    Diagnostic Test: Assessment

Interventions

  • Diagnostic testAssessment

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 minutes

Secondary outcomes

  1. 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.

    Time frame: 30 minutes

07

Study locations

1 site
  • Erzurum Technical University
    Erzurum, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06216379
Lead sponsor
Gazi University
Responsible party
Ayse Simsek (Gazi University, Gazi University) — Principal investigator
First posted
Jan 22, 2024
Start date
Mar 1, 2023
Primary completion
Aug 1, 2023
Completion
Dec 1, 2023
Last update
Jan 22, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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