Cerebral PalsyNCT03616080
Soccer Play in Children With Cerebral Palsy
A study testing soccer play program in people with Cerebral Palsy, run by The Catholic University of Korea at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- soccer play program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Dec 2017to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with cerebral palsy
- GMFCS level I-II
- 5-12 years old
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Soccer Play in Children With Cerebral Palsy
- To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
- To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
- Safety of soccer play in children with cerebral palsy
Read the detailed description
- 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)
- Conditions
- Cerebral Palsy
- Being tested
- soccer play program
- Keywords
- cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soccer play programBehavioural
once a week for an hour of a soccer program for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | children who participated in soccer play program usual activity and therapy + soccer play program (once a week for eight weeks) Receives: Behavioral: soccer play program |
| control | No intervention | children without soccer paly program usual activity and therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FVC after soccer program
FVC, forced vital capacity (L)
Measured: before and after the program, up to 10 weeks interval
Secondary outcomes (8)
Change of gross motor function after soccer program
GMFM-88 (Gross motor function measure-88)
Measured: before and after the program, up to 10 weeks interval
Change of balance after soccer program1
Pediatric balance scale (PBS)
Measured: before and after the program, up to 10 weeks interval
Change of balance after soccer program2
timed up and go test (second)
Measured: before and after the program, up to 10 weeks interval
Change of anaerobic test after soccer program
Muscle Power Sprint Test (MPST), Power (watt)
Measured: before and after the program, up to 10 weeks interval
Change of physical activity with soccer program
wear an accelerometer for a week
Measured: before and during the program (about 3-4 weeks interval)
Change of QOL (parents)
CHQ-PF50 (CHILD HEALTH QUESTIONNAIRE- PARENT FORM)
Measured: before and after the program, up to 10 weeks interval
Change of QOL (children)
KIDSCREEN 27
Measured: before and after the program, up to 10 weeks interval
Change of FEV1 after soccer program
FEV1, forced expiratory volume in 1 second (L)
Measured: before and after the program, up to 10 weeks interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start18 Dec 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- all were ambulatory children with CP age 5-12 years old.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Hong, The Catholic University of Korea
- Investigators
- Bo Young Hong, Principal investigator, St. Vincent's hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616080
- Sponsor's protocol ID
- VC17ONSI0205
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2018
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soccer Play in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03616080
- Acronym / sponsor ID
- VC17ONSI0205
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To figure out the effect of soccer play (once a week for 8 weeks) on pulmonary function in children with cerebral palsy
- To find out if the leisure activity (soccer) increase the quality of life, motor function, gait function etc..
- Safety of soccer play in children with cerebral palsy
Detailed description
- 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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- all were ambulatory children with CP age 5-12 years old.
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: soccer play programchildren who participated in soccer play program usual activity and therapy + soccer play program (once a week for eight weeks) |
| control | No intervention | –children without soccer paly program usual activity and therapy |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with cerebral palsy
- GMFCS level I-II
- 5-12 years old
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| soccer play programonce a week for an hour of a soccer program for 8 weeks | Behavioural | experimental |
Primary outcome
Change of FVC after soccer program
Time frame: before and after the program, up to 10 weeks interval
FVC, forced vital capacity (L)
8 secondary outcomes
Change of gross motor function after soccer program
Time frame: before and after the program, up to 10 weeks interval
Change of balance after soccer program1
Time frame: before and after the program, up to 10 weeks interval
Change of balance after soccer program2
Time frame: before and after the program, up to 10 weeks interval
Change of anaerobic test after soccer program
Time frame: before and after the program, up to 10 weeks interval
Change of physical activity with soccer program
Time frame: before and during the program (about 3-4 weeks interval)
Change of QOL (parents)
Time frame: before and after the program, up to 10 weeks interval
Change of QOL (children)
Time frame: before and after the program, up to 10 weeks interval
Change of FEV1 after soccer program
Time frame: before and after the program, up to 10 weeks interval
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Young Hong principal investigator
St. Vincent's hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soccer play program in people with Cerebral Palsy, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of FVC after soccer program (time frame: before and after the program, up to 10 weeks interval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.