The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study

Study Overview
=================
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.

Official Title
-----------------
The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: medication Botulinum A injection.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe cerebral palsy patients(GMFCS level 3,4,5) 2 to 10 years old Exclusion Criteria: Those who disagree with the study. other than cerebral palsy.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cerebral palsy patients<br>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 | Drug: medication Botulinum A injection.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | once at study, when patient enrolled and every once a month for one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 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. | 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. | once at study, when patient enrolled and every once a month for one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip dislocation, GMFCS level 3,4,5