To Observe Ability of Fundamental Movement Skills in Scho... | NCT03152968

Studies
To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District

NCT03152968

Sponsor

Manipal University

Status

Completed

Last Update Posted

Jun 2, 2017Actual

Enrollment

461Actual

Phase

Not provided

Conditions

Physical Activity

Interventions

Not provided

Countries

India

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

May 31, 2017Actual

Completion Date

May 31, 2017Actual

First Submitted Date

May 9, 2017

First Submission Date that Met QC Criteria

May 12, 2017

First Posted Date

May 15, 2017Actual

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

Jun 1, 2017

Last Update Posted Date

Jun 2, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.

Detailed Description

After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school.

1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed.

Children of age above 7 yr. will be explained the class about the study.

Inform sheets will be distributed after conveying the information.

Only the children who get an informed sheet signed will be included in the study.

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 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

461Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fundamental movement skill score	Satisfying the criterion of each skill such as run, jump, catch, throw	immediate

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All children in the age group 5 to 10 year old

Exclusion Criteria:

Cerebral palsy
Attention deficit/hyperactivity disorder
Autism

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Children between age 5 to 10 years going to school in Udupi district, who will get consent sign from the parent will be included.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Sport Science Medicine and Research		Udupi	Karnataka	576104	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28376671	Result	Mukherjee S, Ting Jamie LC, Fong LH. Fundamental Motor Skill Proficiency of 6- to 9-Year-Old Singaporean Children. Percept Mot Skills. 2017 Jun;124(3):584-600. doi: 10.1177/0031512517703005. Epub 2017 Apr 4.
24832979	Result	Birch S, Cummings L, Oxford SW, Duncan MJ. Examining Relative Age Effects in Fundamental Skill Proficiency in British Children Aged 6-11 Years. J Strength Cond Res. 2016 Oct;30(10):2809-15. doi: 10.1519/JSC.0000000000000526.