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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
medication Botulinum A injection.
Sponsored by
Ju Seok Ryu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring hip dislocation, GMFCS level 3,4,5

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cerebral palsy patients

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
Hip and knee joint Range of motion(ROM) test
Measure the range of motion the knee and hip joints.
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.

Full Information

First Posted
September 12, 2018
Last Updated
November 5, 2021
Sponsor
Ju Seok Ryu
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1. Study Identification

Unique Protocol Identification Number
NCT03680196
Brief Title
The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Official Title
The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 6, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ju Seok Ryu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
hip dislocation, GMFCS level 3,4,5

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cerebral palsy patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
medication Botulinum A injection.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from hip adductor and spin muscles electromyography(EMG) test at a month
Description
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.
Time Frame
once at study, when patient enrolled and every once a month for one year
Secondary Outcome Measure Information:
Title
Whole spine AP and total Hip AP X-ray photograph
Description
Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis.
Time Frame
once at study, when patient enrolled and and after six month for one year
Title
hip adductor muscles pressure meter test
Description
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.
Time Frame
once at study, when patient enrolled and every once a month for one year
Title
Likert scale
Description
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
Time Frame
once at study, when patient enrolled and every once a month for one year
Title
Hip and knee joint Range of motion(ROM) test
Description
Measure the range of motion the knee and hip joints.
Time Frame
once at study, when patient enrolled and every once a month for one year
Title
CPCHILD sacle
Description
Evaluate the quality of life for patients with cerebral palsy. CPCHILD scale have 6section and each section measures scores by 0 to 5.
Time Frame
once at study, when patient enrolled and every once a month for one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jusuk Ryu
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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