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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680196
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Ju Seok Ryu, Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: medication Botulinum A injection. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680196


Contacts
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Contact: Jusuk Ryu, M.D. PhD +82-31-787-7739 jseok337@snu.ac.kr
Contact: Yulhyun Park, M.D. +82-10-4107-2653 yulhyunp@gmail.com

Sponsors and Collaborators
Ju Seok Ryu
Investigators
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Study Director: Jusuk Ryu Seoul National University Bundang Hospital
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Responsible Party: Ju Seok Ryu, associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03680196    
Other Study ID Numbers: B-1807-478-001
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ju Seok Ryu, Seoul National University Hospital:
hip dislocation
GMFCS level 3,4,5
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases