Observational Study of the Conjugated Rehabilitation on Children With Cerebral Palsy

NCT ID: NCT02223741

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-05-11

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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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)

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Korean medicine conjugate rehabilitation

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

Korean medical treatment

Intervention Type OTHER

acupuncture and herbal drugs

Conventional rehabilitation

those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies

No interventions assigned to this group

Interventions

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Korean medical treatment

acupuncture and herbal drugs

Intervention Type OTHER

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)
Minimum Eligible Age

6 Months

Maximum Eligible Age

78 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea Health Industry Development Institute

OTHER_GOV

Sponsor Role collaborator

Korean Medicine Hospital of Pusan National University

OTHER

Sponsor Role lead

Responsible Party

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Young Ju Yun

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Ju Yun, MD, Ph D.

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Korean Medicine Hospital

Locations

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Pusan national University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

Seongmo-i Oriental Medical Clinic

Daegu, , South Korea

Site Status

Haema Oriental Medical Clinic

Seoul, , South Korea

Site Status

Heoyoungjin Oriental Medical Clinic

Seoul, , South Korea

Site Status

Dong-Eui University Korean Medical Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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Yoo JE, Yun YJ, Shin YB, Kim NK, Kim SY, Shin MJ, Yu SA. Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy. BMC Complement Altern Med. 2016 Jun 8;16:172. doi: 10.1186/s12906-016-1161-6.

Reference Type DERIVED
PMID: 27267182 (View on PubMed)

Other Identifiers

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CP_conjugated rehabilitation

Identifier Type: -

Identifier Source: org_study_id

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