Cerebral PalsyNCT04489498
Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
An observational study of Cerebral Palsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and… Read more about this study
- Who is it for?
- Ages 1 year to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Sep 2019to 6 Sep 2021
- Phase
- Observational
- 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 1 year to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: It is difficult to find the basis for calculation because there are no papers that measure the body size of children with cerebral palsy and papers that compare with normal children. In particular, children with cerebral palsy are rare diseases, and it is difficult to recruit a large number of subjects.
Who may be able to join
- aged 1 to 13
- Experiment group: Children with cerebral palsy, Control group: Normal children
- Patients who agreed to participate in the study
Who cannot join
- do not agree with the study
- Those who find it difficult to participate under the judgment of the research director
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national university bundang hospital
Seongnam-si, Bundang-gu, 13354
About this study
The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Children with stiff cerebral palsy | Children with stiff cerebral palsy, aged 1 to 13 years | |
| Normal children | Normal children, aged 1 to 13 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric data (body length)
Measure the body length using a tape measure.(cm)
Measured: through study completion, an average of 1 year
Anthropometric data (BMI)
weight and height will be combined to report BMI in kg/m^2
Measured: through study completion, an average of 1 year
Anthropometric data (body circumference )
Measure the body circumference using a tape measure.(cm)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Progression of hip dislocation
It is measured by migration index, which measures the proportion of femoral heads not covered by acetabulum
Measured: Use simple x-ray within 1 year prior to participation
Progression of scoliosis
The degree of scoliosis is measured by Cobbs angle
Measured: Use simple x-ray within 1 year prior to participation
Have hip dislocation surgery
Confirmation of hip dislocation surgery
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start27 Sep 2019
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ju Seok Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489498
- Sponsor's protocol ID
- B-1909/562-302
- Status last verified
- Nov 2021
- First submitted
- 20 Jul 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
- ClinicalTrials.gov ID
- NCT04489498
- Acronym / sponsor ID
- B-1909/562-302
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 28 Jul 2020 (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.
The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with stiff cerebral palsy | – | –Children with stiff cerebral palsy, aged 1 to 13 years |
| Normal children | – | –Normal children, aged 1 to 13 years |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- It is difficult to find the basis for calculation because there are no papers that measure the body size of children with cerebral palsy and papers that compare with normal children. In particular, children with cerebral palsy are rare diseases, and it is difficult to recruit a large number of subjects.
Key inclusion criteria (3 listed)
- aged 1 to 13
- Experiment group: Children with cerebral palsy, Control group: Normal children
- Patients who agreed to participate in the study
Key exclusion criteria (2 listed)
- do not agree with the study
- Those who find it difficult to participate under the judgment of the research director
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anthropometric data (body length)
Time frame: through study completion, an average of 1 year
Measure the body length using a tape measure.(cm)
Anthropometric data (BMI)
Time frame: through study completion, an average of 1 year
weight and height will be combined to report BMI in kg/m^2
Anthropometric data (body circumference )
Time frame: through study completion, an average of 1 year
Measure the body circumference using a tape measure.(cm)
3 secondary outcomes
Progression of hip dislocation
Time frame: Use simple x-ray within 1 year prior to participation
Progression of scoliosis
Time frame: Use simple x-ray within 1 year prior to participation
Have hip dislocation surgery
Time frame: through study completion, an average of 1 year
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 8 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Seoul National University Hospital 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 2 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 8 Nov 2021. 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?
Anthropometric data (body length) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. 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 8 Nov 2021.