- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06216379
Sensory Processing Associated With Motor Skills
January 11, 2024 updated by: Ayse Simsek, Gazi University
Is Sensory Processing Associated With Gross and Fine Motor Skills at 1-Year-Old?
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Erzurum, Turkey
- Erzurum Technical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy children born preterm and term at 12 months of age
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Preterm
Children born before 37 gestational weeks
|
Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated.
|
|
Term
Children born after 37 weeks of gestation
|
Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Sensory Functions in Infants TSFI
Time Frame: 15 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peabody Developmental Motor Scales-2
Time Frame: 30 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
January 11, 2024
First Submitted That Met QC Criteria
January 11, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 11, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-77082166-604.01.02-739050
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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