Preterm BirthNCT06216379
Sensory Processing Associated With Motor Skills
An observational study of Preterm Birth and Sensory Processing Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 12 months
- Conditions the study is for
- Preterm Birth, Sensory Processing Disorder, Motor Delay
- What is being tested?
- Assessment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 12 months
- All sexes
- Child
Study population: Healthy children born preterm and term at 12 months of age
Who may be able to join
- Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks
Who cannot join
- they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Preterm Birth, Sensory Processing Disorder, Motor Delay
- Being tested
- Assessment
- Medical subject headings
- Premature Birth, Psychomotor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentDiagnostic test
Sensory processing skills and gross and fine motor development of preterm and term born children were evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Preterm | Children born before 37 gestational weeks Receives: Diagnostic Test: Assessment | |
| Term | Children born after 37 weeks of gestation Receives: Diagnostic Test: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Simsek, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216379
- Sponsor's protocol ID
- E-77082166-604.01.02-739050
- Status last verified
- Jan 2024
- First submitted
- 11 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Sensory Processing Associated With Gross and Fine Motor Skills at 1-Year-Old?
- ClinicalTrials.gov ID
- NCT06216379
- Acronym / sponsor ID
- E-77082166-604.01.02-739050
- Conditions
- Preterm Birth, Sensory Processing Disorder, Motor Delay
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm | – | Diagnostic Test: AssessmentChildren born before 37 gestational weeks |
| Term | – | Diagnostic Test: AssessmentChildren born after 37 weeks of gestation |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Age groups
- Child
- Study population
- Healthy children born preterm and term at 12 months of age
Key inclusion criteria (1 listed)
- Premature group: Healthy children with a gestational age below 34 weeks Term group: Healthy children with gestational age between 37-41 weeks
Key exclusion criteria (1 listed)
- they had major congenital malformations, had genetic or chromosomal abnormalities, had known metabolic disorders, or had seizures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentSensory processing skills and gross and fine motor development of preterm and term born children were evaluated. | Diagnostic test | Preterm, Term |
Primary outcome
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.
1 secondary outcome
Peabody Developmental Motor Scales-2
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Sensory Processing Disorder, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Sensory Functions in Infants TSFI (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.