The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
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|ClinicalTrials.gov Identifier: NCT03680196|
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Drug: medication Botulinum A injection.||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study|
|Estimated Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: cerebral palsy patients
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.
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.
- 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.
- 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 ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680196
|Contact: Jusuk Ryu, M.D. PhDfirstname.lastname@example.org|
|Contact: Yulhyun Park, M.D.||+email@example.com|
|Study Director:||Jusuk Ryu||Seoul National University Bundang Hospital|