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CompletedNCT03680196Updated Nov 8, 2021

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

An interventional study of medication Botulinum A injection. in Cerebral Palsy, sponsored by Ju Seok Ryu. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2021-11-08.

Sponsored by Ju Seok Ryu · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
2 Years to 10 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cerebral Palsy

Keywords

  • hip dislocation
  • GMFCS level 3,4,5
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's enrollment of 20 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Ju Seok Ryu is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Severe cerebral palsy patients(GMFCS level 3,4,5)
  • 2 to 10 years old

Exclusion criteria

Exclusion Criteria:

  • Those who disagree with the study.
  • other than cerebral palsy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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.

Interventions

  • Drugmedication 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: once at study, when patient enrolled and every once a month for one year

Secondary outcomes

  1. 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.

    Time frame: once at study, when patient enrolled and and after six month for one year

  2. 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.

    Time frame: once at study, when patient enrolled and every once a month for one year

  3. 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

    Time frame: once at study, when patient enrolled and every once a month for one year

  4. Hip and knee joint Range of motion(ROM) test

    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

  5. 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.

    Time frame: once at study, when patient enrolled and every once a month for one year

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, Gyeonggi-do 463-707, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03680196
Lead sponsor
Ju Seok Ryu
Responsible party
Ju Seok Ryu (associate professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Sep 21, 2018
Start date
Dec 6, 2018
Primary completion
Sep 1, 2020
Completion
Aug 30, 2021
Last update
Nov 8, 2021

Study contacts

Jusuk Ryu
study director · Seoul National University Bundang Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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