Cerebral PalsyNCT03680196
The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
A study testing medication Botulinum A injection. in people with Cerebral Palsy, run by Ju Seok Ryu at 1 site in South Korea.
Trial summary
In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- medication Botulinum A injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2018to 30 Aug 2021
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
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
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients.
Read the detailed description
- Design: Prospective study
- Inclusion criteria of patient group: who has a cerebral palsy and GMFCS level 3,4,5
- Intervention: applied medication Botulinum A injection (meditox 200unit)
- Main outcome measures: The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor and muscles pressure test and electromyography(EMG test) test of hip adductor, abductor and spine muscles.
- Conditions
- Cerebral Palsy
- Being tested
- medication Botulinum A injection.
- Keywords
- hip dislocation, GMFCS level 3,4,5
- Medical subject headings
- Cerebral Palsy, Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication Botulinum A injection.Drug
In cerebral palsy patients, Botulinum toxin within the allowable dose of 16 U / kg per body weight will injected into both adductor longus, adductor magnus muscle at 3 U / kg, adductor brevis, and gracilis muscle at a dose of 1 U / kg.
| Study group | Role | What they receive |
|---|---|---|
| cerebral palsy patients | Experimental | cerebral palsy patients who have GMFCS level3,4,5 and 2 years old and under 10 years old apply an A injection of medication Botulinum A injection Receives: Drug: medication Botulinum A injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from hip adductor and spin muscles electromyography(EMG) test at a month
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 and every once a month for one year
Secondary outcomes (5)
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 and after six month for one year
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 and every once a month for one year
Likert scale
Evaluate the satisfaction of botulinum toxin A injection. Likert scale is a response category that indicates the extent to which the question is for or against. Example) Very satisfied - normal - slightly dissatisfied - very dissatisfied
Measured: once at study, when patient enrolled and every once a month for one year
Hip and knee joint Range of motion(ROM) test
Measure the range of motion the knee and hip joints.
Measured: once at study, when patient enrolled and every once a month for one year
CPCHILD sacle
Evaluate the quality of life for patients with cerebral palsy. CPCHILD scale have 6section and each section measures scores by 0 to 5.
Measured: once at study, when patient enrolled and every once a month for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start6 Dec 2018
- Primary completion1 Sep 2020
- Study completion30 Aug 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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
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
- Investigators
- Jusuk Ryu, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680196
- Sponsor's protocol ID
- B-1807-478-001
- Status last verified
- Nov 2021
- First submitted
- 12 Sep 2018
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
- ClinicalTrials.gov ID
- NCT03680196
- Acronym / sponsor ID
- B-1807-478-001
- Conditions
- Cerebral Palsy
- Keywords
- hip dislocation, GMFCS level 3,4,5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ju Seok RyuUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 21 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. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients.
Detailed description
- Design: Prospective study
- Inclusion criteria of patient group: who has a cerebral palsy and GMFCS level 3,4,5
- Intervention: applied medication Botulinum A injection (meditox 200unit)
- Main outcome measures: The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor and muscles pressure test and electromyography(EMG test) test of hip adductor, abductor and spine muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cerebral palsy patients | Experimental | Drug: medication Botulinum A injection.cerebral palsy patients who have GMFCS level3,4,5 and 2 years old and under 10 years old apply an A injection of medication Botulinum A injection |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medication Botulinum A injection.In cerebral palsy patients, Botulinum toxin within the allowable dose of 16 U / kg per body weight will injected into both adductor longus, adductor magnus muscle at 3 U / kg, adductor brevis, and gracilis muscle at a dose of 1 U / kg. | Drug | cerebral palsy patients |
Primary outcome
Change from hip adductor and spin muscles electromyography(EMG) test at a month
Time frame: once at study, when patient enrolled and every once a month for one year
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.
5 secondary outcomes
Whole spine AP and total Hip AP X-ray photograph
Time frame: once at study, when patient enrolled and and after six month for one year
hip adductor muscles pressure meter test
Time frame: once at study, when patient enrolled and every once a month for one year
Likert scale
Time frame: once at study, when patient enrolled and every once a month for one year
Hip and knee joint Range of motion(ROM) test
Time frame: once at study, when patient enrolled and every once a month for one year
CPCHILD sacle
Time frame: once at study, when patient enrolled and every once a month for one 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.
Jusuk Ryu study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medication Botulinum A injection. in people with Cerebral Palsy, 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: 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?
Change from hip adductor and spin muscles electromyography(EMG) test at a month (time frame: once at study, when patient enrolled and every once a month for one year). 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.