NCT03616080

Brief Summary

  1. 1.To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
  2. 2.To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
  3. 3.Safety of soccer play in children with cerebral palsy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 18, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

July 24, 2018

Last Update Submit

June 25, 2019

Conditions

Keywords

cerebral palsy

Outcome Measures

Primary Outcomes (1)

  • Change of FVC after soccer program

    FVC, forced vital capacity (L)

    before and after the program, up to 10 weeks interval

Secondary Outcomes (8)

  • Change of gross motor function after soccer program

    before and after the program, up to 10 weeks interval

  • Change of balance after soccer program1

    before and after the program, up to 10 weeks interval

  • Change of balance after soccer program2

    before and after the program, up to 10 weeks interval

  • Change of anaerobic test after soccer program

    before and after the program, up to 10 weeks interval

  • Change of physical activity with soccer program

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

  • +3 more secondary outcomes

Study Arms (2)

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

control

NO INTERVENTION

children without soccer paly program usual activity and therapy

Interventions

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

experimental

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with cerebral palsy
  • GMFCS level I-II
  • years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Bo Young Hong

    St. Vincent's hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: all were ambulatory children with CP age 5-12 years old.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 24, 2018

First Posted

August 6, 2018

Study Start

December 18, 2017

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations