Soccer Play in Children With Cerebral Palsy | NCT03616080

Studies
Soccer Play in Children With Cerebral Palsy

NCT03616080

Sponsor

The Catholic University of Korea

Status

Completed

Last Update Posted

Jun 27, 2019Actual

Enrollment

19Actual

Phase

Not Applicable

Conditions

Cerebral Palsy

Interventions

soccer play program

Countries

South Korea

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 2019

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

Dec 18, 2017Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Jul 24, 2018

First Submission Date that Met QC Criteria

Jul 31, 2018

First Posted Date

Aug 6, 2018Actual

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 25, 2019

Last Update Posted Date

Jun 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bo Young Hong, Associate professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
Safety of soccer play in children with cerebral palsy

Detailed Description

1 hr of play once a week for 8 weeks of soccer program was done in the experimental group.
Both the experimental and control group were children with ambulatory cerebral palsy aged 5 to 12 years.
Several outcomes were measured before and after the program
- pulmonary function test including FVC, FEV1
- GMFM-88, PBS, walking test, muscle power sprint test, timed up and go, gait parameters
- Child Health Questionnaire Parent Form 50 (CHQ-PF50)
- KIDSCREEN
An accelerometer was worn before the program and during the program for a week (experimental group only)

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	Experimental	children who participated in soccer play program usual activity and therapy + soccer play program (once a week for eight weeks)	Behavioral: soccer play program
control	No Intervention	children without soccer paly program usual activity and therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
soccer play program	Behavioral	once a week for an hour of a soccer program for 8 weeks	experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of FVC after soccer program	FVC, forced vital capacity (L)	before and after the program, up to 10 weeks interval

Secondary Outcomes

Measure	Description	Time Frame
Change of gross motor function after soccer program	GMFM-88 (Gross motor function measure-88)	before and after the program, up to 10 weeks interval
Change of balance after soccer program1	Pediatric balance scale (PBS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with cerebral palsy
GMFCS level I-II
5-12 years old

Exclusion Criteria:

acute disease, less than 6 months from the surgery
the behavioral or psychiatric problem that hinders group activity
intellectual disability to do the questionnaire
who do not participate in the class well (absent more than 3 times)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Young Hong	St. Vincent's hospital, The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Vincent's hospital		Suwon			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

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