Characteristic of Play: Comparison Between Children With... | NCT01130038

Studies
Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development

NCT01130038

Sponsor

Meir Medical Center

Status

Completed

Last Update Posted

Aug 30, 2011Estimated

Enrollment

64Actual

Phase

Not provided

Conditions

Development Coordination Disorder

Interventions

Not provided

Countries

Israel

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 2011

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

Aug 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 24, 2010

First Submission Date that Met QC Criteria

May 24, 2010

First Posted Date

May 25, 2010Estimated

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

Aug 27, 2011

Last Update Posted Date

Aug 30, 2011Estimated

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

There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with DCD and Typical Development
Children with DCD		2 groups Children with DCD and Typical Development

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with proper( age expected) intelligence and IQ level
Study in regular education system
The DCD diagnosis must be confirmed by a pediatrician

Exclusion Criteria:

Score above 9 in the Movement Assessment Battery test for Children
Score below 3.83 in Children Activity Scale for Parents
routinely take medication
any physical limitations
neurologic and/or muscle disease
any significant hearing and/ or vision limitations

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Children aged 4-6 years with Development Coordination Disorder ( DCD) and Children with Typical Development (controlled group)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clalit Medical Center		Gush Dan (Dan Area)			Israel

Condition Browse Module

MeSH Terms

ID	Term
D019957	Motor Skills Disorders

Ancestor Terms

ID	Term
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided