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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03616080
Other study ID # VC17ONSI0205
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2017
Est. completion date October 31, 2018

Study information

Verified date June 2019
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy

2. To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..

3. Safety of soccer play in children with cerebral palsy


Description:

1. 1 hr of play once a week for 8 weeks of soccer program was done in the experimental group.

2. Both the experimental and control group were children with ambulatory cerebral palsy aged 5 to 12 years.

3. 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

4. An accelerometer was worn before the program and during the program for a week (experimental group only)


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 31, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers No
Gender All
Age group 5 Years to 12 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
soccer play program
once a week for an hour of a soccer program for 8 weeks

Locations

Country Name City State
Korea, Republic of St. Vincent's hospital Suwon-si

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of FVC after soccer program FVC, forced vital capacity (L) before and after the program, up to 10 weeks interval
Secondary 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
Secondary Change of balance after soccer program1 Pediatric balance scale (PBS) before and after the program, up to 10 weeks interval
Secondary Change of balance after soccer program2 timed up and go test (second) before and after the program, up to 10 weeks interval
Secondary Change of anaerobic test after soccer program Muscle Power Sprint Test (MPST), Power (watt) before and after the program, up to 10 weeks interval
Secondary Change of physical activity with soccer program wear an accelerometer for a week before and during the program (about 3-4 weeks interval)
Secondary Change of QOL (parents) CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM) before and after the program, up to 10 weeks interval
Secondary Change of QOL (children) KIDSCREEN 27 before and after the program, up to 10 weeks interval
Secondary Change of FEV1 after soccer program FEV1, forced expiratory volume in 1 second (L) before and after the program, up to 10 weeks interval
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