Cerebral Palsy, SpasticNCT03677843
Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
An observational study of Cerebral Palsy, Spastic, run by Ju Seok Ryu at 1 site in South Korea.
Trial summary
In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cerebral Palsy, Spastic
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2018to 31 Dec 2024
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Serious cerebral palsy children(GMFCS 3,4,5) have secondary problems such as hip dislocation and scoliosis. and There are many preliminary reports that hip dislocation occurs from 2 years of age or older.
Who may be able to join
- Severe cerebral palsy patients(GMFCS level 3,4,5)
- 2 to 10 years old
Who cannot join
- Those who disagree with the study.
- other than cerebral palsy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Jusuk Ryu, M.D, PhD, +82-31-787-7739, jseok337@snu.ac.kr
ByoungGon JUNG, BA, +82-31-787-8430, fkan2@naver.com
About this study
In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.
Read the detailed description
Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- hip dislocation, GMFCS level 3,4,5, scoliosis
- Medical subject headings
- Cerebral Palsy, Hip Dislocation, Scoliosis
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 |
|---|---|---|
| cerebral palsy | They are included in GMFCS level 3, 4, 5. and they have diplegia or quadriplegia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hip adductor and spin muscles electromyography(EMG) test
Use EMG to check the activity of the hip adductor and spine muscles of participants.
This figures will give investigators a look at the association with a hip dislocation.
Measured: once at study, when patient enrolled
Secondary outcomes (2)
Whole spine AP and total Hip AP X-ray photograph
Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis.
Measured: once at study, when patient enrolled and after once every six months for three years
hip adductor muscles pressure meter test
Pressures of hip adductors muscles are measured from pressure meter. and This figures will give investigators a look at the association with a hip dislocation.
Measured: once at study, when patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start16 Oct 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ju Seok Ryu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ju Seok Ryu, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677843
- Sponsor's protocol ID
- B-1808/484-302
- Status last verified
- Apr 2024
- First submitted
- 10 Sep 2018
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
- ClinicalTrials.gov ID
- NCT03677843
- Acronym / sponsor ID
- B-1808/484-302
- Conditions
- Cerebral Palsy, Spastic
- Keywords
- hip dislocation, GMFCS level 3,4,5, scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ju Seok RyuUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Sep 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.
In children with cerebral palsy, secondary problems lead to hip dislocation and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.
Detailed description
Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy | – | –They are included in GMFCS level 3, 4, 5. and they have diplegia or quadriplegia |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Serious cerebral palsy children(GMFCS 3,4,5) have secondary problems such as hip dislocation and scoliosis. and There are many preliminary reports that hip dislocation occurs from 2 years of age or older.
Key inclusion criteria (2 listed)
- Severe cerebral palsy patients(GMFCS level 3,4,5)
- 2 to 10 years old
Key exclusion criteria (2 listed)
- Those who disagree with the study.
- other than cerebral palsy.
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
hip adductor and spin muscles electromyography(EMG) test
Time frame: once at study, when patient enrolled
Use EMG to check the activity of the hip adductor and spine muscles of participants. This figures will give investigators a look at the association with a hip dislocation.
2 secondary outcomes
Whole spine AP and total Hip AP X-ray photograph
Time frame: once at study, when patient enrolled and after once every six months for three years
hip adductor muscles pressure meter test
Time frame: once at study, when patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
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, Spastic, run by Ju Seok Ryu 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 2 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JuSuk Ryu, M.D, PhD (+82-31-787-7739, 01040@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hip adductor and spin muscles electromyography(EMG) test (time frame: once at study, when patient enrolled). 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 19 Apr 2024.