Relationship Between Sensory Processing and Motor Develop... | NCT02889887

Studies
Relationship Between Sensory Processing and Motor Development

NCT02889887

Sponsor

Gazi University

Status

Unknown status

Last Update Posted

Sep 7, 2016Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Sensation Disorders

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2016Actual

Completion Date

Oct 2016Estimated

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Sep 6, 2016

First Posted Date

Sep 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Label	Type	Description	Intervention Names
preterm		infants who born before 37 completed weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The investigation of sensory processing in preterm infants	Test of Sensory Function in Infants' was used to evaluate sensory processing in preterm infants.	Day 1

Secondary Outcomes

Measure	Description	Time Frame
The investigation of motor development in preterm infants	Alberta Infant Motor Scale' was used to evaluate motor development in preterm infants.	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

taken physiotherapy or sensory integration therapy in any rehabilitation center
having newborn retinopathy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Months

Maximum Age

12 Months

Standard Ages

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HALİL İ ÇELİK	Gazi University	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29280716	Derived	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.

ID	Term
D012678	Sensation Disorders
D047928	Premature Birth

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms