Skip to main content
OpenTrials
Completed

NCT Number: NCT03680196

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Nervous System Diseases Wounds and Injuries

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

medication Botulinum A injection.

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.

Primary outcomes

  1. 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

  1. Whole spine AP and total Hip AP X-ray photograph

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

    Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis.

  2. hip adductor muscles pressure meter test

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

    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.

  3. Likert scale

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

    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

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

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

    Measure the range of motion the knee and hip joints.

  5. CPCHILD sacle

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

    Evaluate the quality of life for patients with cerebral palsy. CPCHILD scale have 6section and each section measures scores by 0 to 5.

Sponsors and collaborators

Lead sponsor

Ju Seok Ryu

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 21, 2018
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.