Soccer Play in Children With Cerebral Palsy

Effect of 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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: soccer play program

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)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon-si, Korea, Republic of
    • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; once a week for an hour of a soccer program for 8 weeks
No Intervention: control; children without soccer paly program usual activity and therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)	before and after the program, up to 10 weeks interval
Change of balance after soccer program2	timed up and go test (second)	before and after the program, up to 10 weeks interval
Change of anaerobic test after soccer program	Muscle Power Sprint Test (MPST), Power (watt)	before and after the program, up to 10 weeks interval
Change of physical activity with soccer program	wear an accelerometer for a week	before and during the program (about 3-4 weeks interval)
Change of QOL (parents)	CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM)	before and after the program, up to 10 weeks interval
Change of QOL (children)	KIDSCREEN 27	before and after the program, up to 10 weeks interval
Change of FEV1 after soccer program	FEV1, forced expiratory volume in 1 second (L)	before and after the program, up to 10 weeks interval

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Principal Investigator: Bo Young Hong, St. Vincent's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: cerebral palsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: VC17ONSI0205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No