Sensation DisordersNCT02889887
Relationship Between Sensory Processing and Motor Development
An observational study of Sensation Disorders, run by Gazi University.
Trial summary
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. Read more about this study
- Who is it for?
- Ages 10 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Sensation Disorders
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Oct 2016
- How long will I take part?
- 1 Day
- 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 10 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study.
Who may be able to join
- gestational age lower than 37 month
- corrected age within 10-12 months
- without congenital anomaly or systemic disease
- stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks
Who cannot join
- taken physiotherapy or sensory integration therapy in any rehabilitation center
- having newborn retinopathy
About this study
Official title: The Investigation of Relationship Between Sensory Processing and Motor Development in Preterm Infants
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.
Read the detailed description
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. Test of Sensory Function in Infants was used to evaluate sensory processing, and Alberta Infant Motor Scale was used to evaluate motor development.Spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. Given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.
- Conditions
- Sensation Disorders
- Keywords
- Preterm, Sensory Processing, Motor Development
- Medical subject headings
- Sensation Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| preterm | infants who born before 37 completed weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The investigation of sensory processing in preterm infants
Test of Sensory Function in Infants' was used to evaluate sensory processing in preterm infants.
Measured: Day 1
Secondary outcomes (1)
The investigation of motor development in preterm infants
Alberta Infant Motor Scale' was used to evaluate motor development in preterm infants.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensation DisordersStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Celik, Gazi University
- Investigators
- HALİL İ ÇELİK, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889887
- Sponsor's protocol ID
- HalilÇ
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Celik HI, Elbasan B, Gucuyener K, Kayihan H, Huri M. Investigation of the Relationship Between Sensory Processing and Motor Development in Preterm Infants. Am J Occup Ther. 2018 Jan/Feb;72(1):7201195020p1-7201195020p7. doi: 10.5014/ajot.2018.026260.
PubMed 29280716
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of Relationship Between Sensory Processing and Motor Development in Preterm Infants
- ClinicalTrials.gov ID
- NCT02889887
- Acronym / sponsor ID
- HalilÇ
- Conditions
- Sensation Disorders
- Keywords
- Preterm, Sensory Processing, Motor Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants.
Detailed description
The aim of this study is to analyse correlation between the sensory processing and motor development in preterm infants. A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study. Test of Sensory Function in Infants was used to evaluate sensory processing, and Alberta Infant Motor Scale was used to evaluate motor development.Spearman correlation test indicated strong positive relation between sensory processing and motor development in preterm infants. Given the relationship between sensory processing and motor development in preterm group, for effective implementation of physiotherapy assessments and interventions, it was thought that it is necessary to evaluate the sensory processing as well as the motor development in preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preterm | – | –infants who born before 37 completed weeks |
Who may qualify
- Ages
- 10 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of 60 infants who were born preterm (n=30) and term (n=30), the corrected and chronological ages between 10-12 months, were included in this study.
Key inclusion criteria (4 listed)
- gestational age lower than 37 month
- corrected age within 10-12 months
- without congenital anomaly or systemic disease
- stay in Neonatal Intensive Care Unit (NICU) at least 2 weeks
Key exclusion criteria (2 listed)
- taken physiotherapy or sensory integration therapy in any rehabilitation center
- having newborn retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The investigation of sensory processing in preterm infants
Time frame: Day 1
Test of Sensory Function in Infants' was used to evaluate sensory processing in preterm infants.
1 secondary outcome
The investigation of motor development in preterm infants
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 29280716Celik HI, Elbasan B, Gucuyener K, Kayihan H, Huri M. Investigation of the Relationship Between Sensory Processing and Motor Development in Preterm Infants. Am J Occup Ther. 2018 Jan/Feb;72(1):7201195020p1-7201195020p7. doi: 10.5014/ajot.2018.026260.
- Individual participant dataSharing planned: No
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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.
HALİL İ ÇELİK principal investigator
Gazi University
Questions about this trial
What is this clinical trial studying?
An observational study of Sensation Disorders, run by Gazi University.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The investigation of sensory processing in preterm infants (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889887, which also lists 1 linked publication.
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 7 Sep 2016; AzTrials last refreshed its copy on 29 Oct 2026.