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Soccer Play in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
soccer play program
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Palsy focused on measuring cerebral palsy

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • St. Vincent's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental

control

Arm Description

children who participated in soccer play program usual activity and therapy + soccer play program (once a week for eight weeks)

children without soccer paly program usual activity and therapy

Outcomes

Primary Outcome Measures

Change of FVC after soccer program
FVC, forced vital capacity (L)

Secondary Outcome Measures

Change of gross motor function after soccer program
GMFM-88 (Gross motor function measure-88)
Change of balance after soccer program1
Pediatric balance scale (PBS)
Change of balance after soccer program2
timed up and go test (second)
Change of anaerobic test after soccer program
Muscle Power Sprint Test (MPST), Power (watt)
Change of physical activity with soccer program
wear an accelerometer for a week
Change of QOL (parents)
CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM)
Change of QOL (children)
KIDSCREEN 27
Change of FEV1 after soccer program
FEV1, forced expiratory volume in 1 second (L)

Full Information

First Posted
July 24, 2018
Last Updated
June 25, 2019
Sponsor
The Catholic University of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03616080
Brief Title
Soccer Play in Children With Cerebral Palsy
Official Title
Effect of Soccer Play in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
all were ambulatory children with CP age 5-12 years old.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
children who participated in soccer play program usual activity and therapy + soccer play program (once a week for eight weeks)
Arm Title
control
Arm Type
No Intervention
Arm Description
children without soccer paly program usual activity and therapy
Intervention Type
Behavioral
Intervention Name(s)
soccer play program
Intervention Description
once a week for an hour of a soccer program for 8 weeks
Primary Outcome Measure Information:
Title
Change of FVC after soccer program
Description
FVC, forced vital capacity (L)
Time Frame
before and after the program, up to 10 weeks interval
Secondary Outcome Measure Information:
Title
Change of gross motor function after soccer program
Description
GMFM-88 (Gross motor function measure-88)
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of balance after soccer program1
Description
Pediatric balance scale (PBS)
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of balance after soccer program2
Description
timed up and go test (second)
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of anaerobic test after soccer program
Description
Muscle Power Sprint Test (MPST), Power (watt)
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of physical activity with soccer program
Description
wear an accelerometer for a week
Time Frame
before and during the program (about 3-4 weeks interval)
Title
Change of QOL (parents)
Description
CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM)
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of QOL (children)
Description
KIDSCREEN 27
Time Frame
before and after the program, up to 10 weeks interval
Title
Change of FEV1 after soccer program
Description
FEV1, forced expiratory volume in 1 second (L)
Time Frame
before and after the program, up to 10 weeks interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Hong
Organizational Affiliation
St. Vincent's hospital, The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's hospital
City
Suwon-si
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Soccer Play in Children With Cerebral Palsy

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