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Clinical Trials/NCT03680196
NCT03680196
Completed
Not Applicable

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

Ju Seok Ryu1 site in 1 country20 target enrollmentDecember 6, 2018

Overview

Phase
Not Applicable
Intervention
medication Botulinum A injection.
Conditions
Cerebral Palsy
Sponsor
Ju Seok Ryu
Enrollment
20
Locations
1
Primary Endpoint
Change from hip adductor and spin muscles electromyography(EMG) test at a month
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2018
End Date
August 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ju Seok Ryu
Responsible Party
Sponsor Investigator
Principal Investigator

Ju Seok Ryu

associate professor

Seoul National University Hospital

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.

Arms & Interventions

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

Intervention: medication Botulinum A injection.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Whole spine AP and total Hip AP X-ray photograph(once at study, when patient enrolled and and after six month for one year)
  • hip adductor muscles pressure meter test(once at study, when patient enrolled and every once a month for one year)
  • Likert scale(once at study, when patient enrolled and every once a month for one year)
  • Hip and knee joint Range of motion(ROM) test(once at study, when patient enrolled and every once a month for one year)
  • CPCHILD sacle(once at study, when patient enrolled and every once a month for one year)

Study Sites (1)

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