NCT04489498

Brief Summary

The purpose of this study is to: 1) secure basic data of patients with cerebral palsy, 2) seek ways to simplify the data for clinical application, 3) progress of hip dislocation, presence or absence of hip surgery, and The purpose of this study is to compare differences in body development according to severity and nutritional methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

1.9 years

First QC Date

July 20, 2020

Last Update Submit

November 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Anthropometric data (body length)

    Measure the body length using a tape measure.(cm)

    through study completion, an average of 1 year

  • Anthropometric data (BMI)

    weight and height will be combined to report BMI in kg/m\^2

    through study completion, an average of 1 year

  • Anthropometric data (body circumference )

    Measure the body circumference using a tape measure.(cm)

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • Progression of hip dislocation

    Use simple x-ray within 1 year prior to participation

  • Progression of scoliosis

    Use simple x-ray within 1 year prior to participation

  • Have hip dislocation surgery

    through study completion, an average of 1 year

Study Arms (2)

Children with stiff cerebral palsy

Children with stiff cerebral palsy, aged 1 to 13 years

Normal children

Normal children, aged 1 to 13 years

Eligibility Criteria

Age1 Year - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

It is difficult to find the basis for calculation because there are no papers that measure the body size of children with cerebral palsy and papers that compare with normal children. In particular, children with cerebral palsy are rare diseases, and it is difficult to recruit a large number of subjects.

You may qualify if:

  • aged 1 to 13
  • Experiment group: Children with cerebral palsy, Control group: Normal children
  • Patients who agreed to participate in the study

You may not qualify if:

  • do not agree with the study
  • Those who find it difficult to participate under the judgment of the research director

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university bundang hospital

Seongnam-si, Bundang-gu, 13354, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 28, 2020

Study Start

September 27, 2019

Primary Completion

September 6, 2021

Study Completion

September 6, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Locations