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Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline

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ClinicalTrials.gov Identifier: NCT03677843
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 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 and scoliosis. But There is no definite evidence for the dislocation of hip and scoliosis. The investigators want to verify evidence of scoliosis and dislocation of hip.

Condition or disease
Cerebral Palsy, Spastic

Detailed Description:
Observation cohort study. The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor muscles pressure test and electromyography(EMG test) test of hip adductor and spine muscles

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multidimensional Approach in Patients With Severe Cerebral Palsy, Prospective Cohort(MAPCP Cohort)-Offline
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
cerebral palsy
They are included in GMFCS level 3, 4, 5. and they have diplegia or quadriplegia



Primary Outcome Measures :
  1. hip adductor and spin muscles electromyography(EMG) test [ Time Frame: once at study, when patient enrolled ]

    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 after once every six months for three years ]
    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 ]
    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.



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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Serious cerebral palsy children(GMFCS 3,4,5) have secondary problems such as hip dislocation and scoliosis. and There are many preliminary reports that hip dislocation occurs from 2 years of age or older.
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): NCT03677843


Contacts
Contact: JuSuk Ryu, M.D, PhD +82-31-787-7739 01040@snubh.org
Contact: YulHyeon Park, M.D +82-31-787-4999 82246@snubh.org

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Jusuk Ryu, M.D, PhD    +82-31-787-7739    jseok337@snu.ac.kr   
Contact: ByoungGon JUNG, BA    +82-31-787-8430    fkan2@naver.com   
Sponsors and Collaborators
Ju Seok Ryu

Responsible Party: Ju Seok Ryu, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03677843     History of Changes
Other Study ID Numbers: B-1808/484-302
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
scoliosis

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases