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

Not Applicable

Completed

• 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.

Study Timeline

• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-21
• Study Start: 2018-12-06
• Primary Completion: 2020-09-01
• Study Completion: 2021-08-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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