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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03680196
• Other study ID #: B-1807-478-001
• Status: Completed
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 30, 2021
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ju Seok Ryu

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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