The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
- Conditions
- Cerebral Palsy
- Interventions
- Drug: medication Botulinum A injection.
- Registration Number
- NCT03680196
- Lead Sponsor
- Ju Seok Ryu
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Severe cerebral palsy patients(GMFCS level 3,4,5)
- 2 to 10 years old
- Those who disagree with the study.
- other than cerebral palsy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cerebral palsy patients 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
- Primary Outcome Measures
Name Time Method Change from hip adductor and spin muscles electromyography(EMG) test at a month 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.
- Secondary Outcome Measures
Name Time Method Whole spine AP and total Hip AP X-ray photograph once at study, when patient enrolled and and after six month for one year Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis.
hip adductor muscles pressure meter test once at study, when patient enrolled and every once a month for one year 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.
Likert scale once at study, when patient enrolled and every once a month for one year 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
Hip and knee joint Range of motion(ROM) test once at study, when patient enrolled and every once a month for one year Measure the range of motion the knee and hip joints.
CPCHILD sacle once at study, when patient enrolled and every once a month for one year Evaluate the quality of life for patients with cerebral palsy. CPCHILD scale have 6section and each section measures scores by 0 to 5.
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of