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

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.

Study Overview

• Status: Recruiting
• Conditions: 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
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: JuSuk Ryu, M.D, PhD; Phone Number: +82-31-787-7739; Email: 01040@snubh.org
• Study Contact Backup: Name: YulHyeon Park, M.D; Phone Number: +82-31-787-4999; Email: 82246@snubh.org

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Jusuk Ryu, M.D, PhD; Phone Number: +82-31-787-7739; Email: jseok337@snu.ac.kr
      • Contact: ByoungGon JUNG, BA; Phone Number: +82-31-787-8430; Email: fkan2@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hip adductor and spin muscles electromyography(EMG) test	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.	once at study, when patient enrolled

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Whole spine AP and total Hip AP X-ray photograph	Whole spine and total Hip joint are checked with X-ray photograph. and investigators will check the progress of hip dislocation and spinal scoliosis.	once at study, when patient enrolled and after once every six months for three years
hip adductor muscles pressure meter test	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.	once at study, when patient enrolled

Collaborators and Investigators

• Sponsor: Ju Seok Ryu

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: scoliosis; hip dislocation; GMFCS level 3,4,5
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B-1808/484-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No