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

NCT ID: NCT03680196

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2021-08-30

Brief Summary

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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

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* 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.

Conditions

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Cerebral Palsy

Keywords

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hip dislocation GMFCS level 3,4,5

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

medication Botulinum A injection.

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ju Seok Ryu

OTHER

Sponsor Role lead

Responsible Party

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Ju Seok Ryu

associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jusuk Ryu

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1807-478-001

Identifier Type: -

Identifier Source: org_study_id