Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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Survey 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 An interview survey on 26th and 52nd weeks Accompanied disorders Health problems A weekly tracking survey Health problems Therapeutic change Medical care cost Quality of life 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)

Official Title
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An Observational Study of the Conventional Rehabilitation and Traditional Korean Medicine Conjugated Rehabilitation on Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Korean medical treatment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 78 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean medicine conjugate rehabilitation<br>those with more than 30 days of herbal drugs or more than 12 times of acupuncture (Korean medical treatment) within six months in addition to conventional rehabilitation | Other: Korean medical treatment<br>* acupuncture and herbal drugs<br>|
| Conventional rehabilitation<br>those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline, Week 26, Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of severity from baseline on accompanied disorders and health problems at week 24 and 52 |  | Baseline, Week 26, Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy, GMFM-66, PEDI