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The Reliability of Neuromotor assessment using TIMPSI in Infants

Status Approved

First Submitted Date

2020/11/20
Registered Date

2020/11/27
Last Updated Date

2020/11/20

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005640
Unique Protocol ID	1040460-A-2020-041
Public/Brief Title	The Reliability of Neuromotor assessment using TIMPSI in Infants
Scientific Title	The Reliability of Neuromotor assessment using TIMPSI in Infants
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	1040460-A-2020-041
Approval Date	2020-11-13
Institutional Review Board Name	kyungnam university IRB
Institutional Review Board Address	7, Gyeongnamdaehak-ro, Masanhappo-gu, Changwon-si, Gyeongsangnam-do
Institutional Review Board Telephone	055-249-2290
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	jeongeun yoon
Title	physical therapist
Telephone	+82-55-286-1518
Affiliation	Kyungnam University
Address	7 Gyeongnam University Road, Masanhappo-gu, Changwon, Gyeongsangnam-do
Contact Person for Public Queries
Name	jeongeun yoon
Title	physical therapist
Telephone	+82-55-286-1518
Affiliation	Kyungnam University
Address	7 Gyeongnam University Road, Masanhappo-gu, Changwon, Gyeongsangnam-do
Contact Person for Updating Information
Name	jeongeun yoon
Title	physical therapist
Telephone	+82-55-286-1518
Affiliation	Kyungnam University
Address	7 Gyeongnam University Road, Masanhappo-gu, Changwon, Gyeongsangnam-do

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-11-23 Anticipated
Target Number of Participant	20
Primary Completion Date
Study Completion Date
Name of Study	Kyungnam University
Recruitment Status	Not yet recruiting
Date of First Enrollment	2020-11-23 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Kyungnam University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyungnam University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	The number of infants with motor disorders ranging from developmental disorders to cerebral palsy is increasing as the survival rate of premature and underweight newborns increases. There is a high risk of delayed motor development due to neurological damage, and these infants should be identified early and proper intervention should be carried out. TIMP was developed for the measurement of motor prognosis and is an evaluation tool with high reliability and validity for the evaluation of motor activities for infants under 4 months old. However, it is difficult to evaluate infants who are vulnerable to external environmental stimuli because of the long evaluation time. Therefore, TIMP-Screening items (TIMP-SI) have been developed to identify infants who need to perform the full version of TIMP. The reliability study of this TIMP-SI is in short supply. Therefore, this study aims to examine the reliability of the assessment TIMP-SI developed for early application of appropriate tests and therapeutic interventions by early screening of infants suspected of delayed motor development.

Study Summary Information

Lay Summary

The number of infants with motor disorders ranging from developmental disorders to cerebral palsy is increasing as the survival rate of premature and underweight newborns increases. There is a high risk of delayed motor development due to neurological damage, and these infants should be identified early and proper intervention should be carried out. TIMP was developed for the measurement of motor prognosis and is an evaluation tool with high reliability and validity for the evaluation of motor activities for infants under 4 months old. However, it is difficult to evaluate infants who are vulnerable to external environmental stimuli because of the long evaluation time. Therefore, TIMP-Screening items (TIMP-SI) have been developed to identify infants who need to perform the full version of TIMP. The reliability study of this TIMP-SI is in short supply. Therefore, this study aims to examine the reliability of the assessment TIMP-SI developed for early application of appropriate tests and therapeutic interventions by early screening of infants suspected of delayed motor development.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Others
Time Perspective	Cross-sectional
Target Number of Participant	20
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Infants under 4months
Cohort/ Group 1	Cohort/Group Description Infants under 4 months who visited at hongik Rehabilitation hospital
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Infants under 4 months
Sampling Method	Infant under 4 months who visited at Hongik Rehabilitation Hospital
Condition(s)/Problem(s)	* (P00-P96)Certain conditions originating in the perinatal period (P07.19)Other low birth weight, unspecified weight infant, Developmental Disabilities
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~4Month
	Description Infant under 4 months
Exclusion Criteria	1.visual or auditory deficit 2. hereditary metabolic disease 3. congenital malformation or congenital heart disease
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Intra-rater reliability
Timepoint	frist day and last day
Secondary Outcome(s) 1
Outcome	Inter-rater reliability
Timepoint	frist day and last day

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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