Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy

• Study Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang-gu
    • Seongnam-si, Bundang-gu, Korea, Republic of, 13354
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 13 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children with stiff cerebral palsy; Children with stiff cerebral palsy, aged 1 to 13 years
Normal children; Normal children, aged 1 to 13 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of hip dislocation	It is measured by migration index, which measures the proportion of femoral heads not covered by acetabulum	Use simple x-ray within 1 year prior to participation
Progression of scoliosis	The degree of scoliosis is measured by Cobbs angle	Use simple x-ray within 1 year prior to participation
Have hip dislocation surgery	Confirmation of hip dislocation surgery	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): September 6, 2021
• Study Completion (Actual): September 6, 2021

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B-1909/562-302

Drug and device information, study documents

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