NCT03677843

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

6.2 years

First QC Date

September 10, 2018

Last Update Submit

April 18, 2024

Conditions

Keywords

hip dislocationGMFCS level 3,4,5scoliosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Whole spine AP and total Hip AP X-ray photograph

    once at study, when patient enrolled and after once every six months for three years

  • hip adductor muscles pressure meter test

    once at study, when patient enrolled

Study Arms (1)

cerebral palsy

They are included in GMFCS level 3, 4, 5. and they have diplegia or quadriplegia

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Severe cerebral palsy patients(GMFCS level 3,4,5)
  • to 10 years old

You may not qualify if:

  • Those who disagree with the study.
  • other than cerebral palsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

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

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyHip DislocationScoliosis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesJoint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesHip InjuriesSpinal CurvaturesSpinal DiseasesBone Diseases

Central Study Contacts

JuSuk Ryu, M.D, PhD

CONTACT

YulHyeon Park, M.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 19, 2018

Study Start

October 16, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations