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| Name | Class |
|---|---|
| Korea Health Industry Development Institute | OTHER_GOV |
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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.
Survey
An interview survey on baseline
An interview survey on 26th and 52nd weeks
A weekly tracking survey
Assessment for function development on baseline, 26th and 52nd weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Conventional rehabilitation | those with one of the treatments; physical, occupational, speech-language or cognitive-behavioral therapies |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Korean medical treatment | Other | acupuncture and herbal drugs |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Economy evaluation | Direct and indirect medical care cost, Labor productivity of family | Baseline, Week 26, Week 52 |
| Number of Participants with Serious and Non-Serious Adverse Events | up to 52 weeks |
Inclusion Criteria:
Exclusion Criteria:
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Population will be selected from rehabilitation clinics for children
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| Name | Affiliation | Role |
|---|---|---|
| Young-Ju Yun, MD, Ph D. | Pusan National University Korean Medicine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan national University Yangsan Hospital | Yangsan | Gyeongsangnam-do | South Korea | |||
| Pusan National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27267182 | Derived | 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. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Change from baseline on height and weight at week 24 and 52 | Baseline, Week 26, Week 52 |
| Busan |
| 602-739 |
| South Korea |
| Seongmo-i Oriental Medical Clinic | Daegu | 563-4 | South Korea |
| Haema Oriental Medical Clinic | Seoul | 1605-5 | South Korea |
| Heoyoungjin Oriental Medical Clinic | Seoul | 936-7 | South Korea |
| Dong-Eui University Korean Medical Hospital | Ulsan | 479-7 | South Korea |