Clinical trial NCT03616080: Soccer Play in Children With Cerebral Palsy
Official title: Effect of Soccer Play in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 19
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: all were ambulatory children with CP age 5-12 years old.
Primary purpose: OTHER

Brief 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

Detailed 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)

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)

Primary outcomes:
measure: Change of FVC after soccer program
timeFrame: before and after the program, up to 10 weeks interval
Secondary outcomes:
measure: Change of gross motor function after soccer program
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of balance after soccer program1
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of balance after soccer program2
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of anaerobic test after soccer program
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of physical activity with soccer program
timeFrame: before and during the program (about 3-4 weeks interval)
measure: Change of QOL (parents)
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of QOL (children)
timeFrame: before and after the program, up to 10 weeks interval
measure: Change of FEV1 after soccer program
timeFrame: before and after the program, up to 10 weeks interval
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's hospital
Study officials:
affiliation: St. Vincent's hospital, The Catholic University of Korea
name: Bo Young Hong
role: PRINCIPAL_INVESTIGATOR
References: