Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

Korean Medicine Hospital of Pusan National University207 enrolled

Overview

This study is designed to assess effectiveness, safety and cost-utility of conventional rehabilitation and traditional Korean medicine conjugated rehabilitation on children with cerebral palsy.

1. Survey 1. An interview survey on baseline * Basic characteristics * Cause of cerebral palsy * Accompanied disorders * Health problems * Operation history * Drug-taking * Rehabilitation treatment * Korean medicine treatment * Health functional food * Medical care cost 2. An interview survey on 26th and 52nd weeks * Accompanied disorders * Health problems 3. A weekly tracking survey * Health problems * Therapeutic change * Medical care cost * Quality of life 2. Assessment for function development on baseline, 26th and 52nd weeks * Gross Motor Function Classification System (GMFCS) * Gross Motor Function Measure-66 (GMFM-66) * Pediatric Evaluation of Disability Inventory (PEDI)

Study Type

OBSERVATIONAL

Enrollment

207

Conditions

Cerebral Palsy

Interventions

Korean medical treatmentOTHER

acupuncture and herbal drugs

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 78 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Children with cerebral palsy * Age from 6 to 78 months * whose guardian consent to the present study Exclusion Criteria: * who had an orthopedic operation due to cerebral palsy * who has congenital muscular disease, hereditary disease, or progressive central nervous system diseases * who suffers from severe diseases (ie, cancer, severe heart disease, severe infectious disease)

Locations (6)

Pusan national University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Pusan National University Hospital

Busan, South Korea

Seongmo-i Oriental Medical Clinic

Daegu, South Korea

Haema Oriental Medical Clinic

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline on GMFM-66 scores at week 26 and 52

The GMFM-66 includes 66 items identified through Rasch analysis, which, together, best describe gross motor function in children with cerebral palsy of varying abilities.

Time frame: Baseline, Week 26, Week 52

Change from baseline on PEDI scores at week 26 and 52

The PEDI measures abilities in the three functional domains of self-care, mobility and social function with 217 questions.

Time frame: Baseline, Week 26, Week 52

Secondary Outcomes

Change of severity from baseline on accompanied disorders and health problems at week 24 and 52

Time frame: Baseline, Week 26, Week 52

Data from ClinicalTrials.gov

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