## Protocol Section
### Identification Module
**NCT ID:** NCT06216379

**Brief Title:** Sensory Processing Associated With Motor Skills

**Official Title:** Is Sensory Processing Associated With Gross and Fine Motor Skills at 1-Year-Old?

#### Organization Study ID Info
**ID:** E-77082166-604.01.02-739050
#### Organization
**Class:** OTHER
**Full Name:** Gazi University
### Status Module
#### Completion Date
**Date:** 2023-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-08-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-11
**Study First Submit QC Date:** 2024-01-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Gazi University

#### Responsible Party

**Investigator Affiliation:** Gazi University

**Investigator Full Name:** Ayse Simsek

**Investigator Title:** Gazi University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Preterm Birth

- Sensory Processing Disorder

- Motor Delay

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 61

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Children born before 37 gestational weeks

**Intervention Names:**

- Diagnostic Test: Assessment

**Label:** Preterm

#### Arm Group 2

**Description:** Children born after 37 weeks of gestation

**Intervention Names:**

- Diagnostic Test: Assessment

**Label:** Term

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Preterm

- Term

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

**Name:** Assessment

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Test of Sensory Functions in Infants TSFI

**Time Frame:** 15 minutes

#### Secondary Outcomes

**Description:** 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.

**Measure:** Peabody Developmental Motor Scales-2

**Time Frame:** 30 minutes

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 12 Months

**Minimum Age:** 12 Months

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Healthy children born preterm and term at 12 months of age

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Erzurum

**Country:** Turkey

**Facility:** Erzurum Technical University

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm Birth

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-24
