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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03680196
Enrollment
20
Registered
2018-09-21
Start date
2018-12-06
Completion date
2021-08-30
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

hip dislocation, GMFCS level 3,4,5

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.

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.

Sponsors

Ju Seok Ryu
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from hip adductor and spin muscles electromyography(EMG) test at a monthonce at study, when patient enrolled and every once a month for one yearUse 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

MeasureTime frameDescription
Whole spine AP and total Hip AP X-ray photographonce at study, when patient enrolled and and after six month for one yearWhole 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 testonce at study, when patient enrolled and every once a month for one yearPressures 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 scaleonce at study, when patient enrolled and every once a month for one yearEvaluate 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) testonce at study, when patient enrolled and every once a month for one yearMeasure the range of motion the knee and hip joints.
CPCHILD sacleonce at study, when patient enrolled and every once a month for one yearEvaluate the quality of life for patients with cerebral palsy. CPCHILD scale have 6section and each section measures scores by 0 to 5.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026