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Completed

NCT Number: NCT03616080

Soccer Play in Children With Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's hospital

Suwon, South Korea

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

soccer play program

Behavioral

once a week for an hour of a soccer program for 8 weeks

Primary outcomes

  1. Change of FVC after soccer program

    Time frame: before and after the program, up to 10 weeks interval

    FVC, forced vital capacity (L)

Secondary outcomes

  1. Change of gross motor function after soccer program

    Time frame: before and after the program, up to 10 weeks interval

    GMFM-88 (Gross motor function measure-88)

  2. Change of balance after soccer program1

    Time frame: before and after the program, up to 10 weeks interval

    Pediatric balance scale (PBS)

  3. Change of balance after soccer program2

    Time frame: before and after the program, up to 10 weeks interval

    timed up and go test (second)

  4. Change of anaerobic test after soccer program

    Time frame: before and after the program, up to 10 weeks interval

    Muscle Power Sprint Test (MPST), Power (watt)

  5. Change of physical activity with soccer program

    Time frame: before and during the program (about 3-4 weeks interval)

    wear an accelerometer for a week

  6. Change of QOL (parents)

    Time frame: before and after the program, up to 10 weeks interval

    CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM)

  7. Change of QOL (children)

    Time frame: before and after the program, up to 10 weeks interval

    KIDSCREEN 27

  8. Change of FEV1 after soccer program

    Time frame: before and after the program, up to 10 weeks interval

    FEV1, forced expiratory volume in 1 second (L)

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

Effect of Soccer Play in Children With Cerebral Palsy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 6, 2018
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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