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Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy

BACKGROUND: Cerebral palsy leads to many complications as well as delayed motor development, and early intensive rehabilitation in infancy, which is based on the theory of brain plasticity, is emphasized. In addition to conventional treatment, including physical, occupational, or speech-language the...

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Autores principales: Yoo, Jeong-Eun, Yun, Young-Ju, Shin, Yong-Beom, Kim, Nam-kwen, Kim, Soo-Yeon, Shin, Myung-Jun, Yu, Sun-ae
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4897905/
https://www.ncbi.nlm.nih.gov/pubmed/27267182
http://dx.doi.org/10.1186/s12906-016-1161-6
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author Yoo, Jeong-Eun
Yun, Young-Ju
Shin, Yong-Beom
Kim, Nam-kwen
Kim, Soo-Yeon
Shin, Myung-Jun
Yu, Sun-ae
author_facet Yoo, Jeong-Eun
Yun, Young-Ju
Shin, Yong-Beom
Kim, Nam-kwen
Kim, Soo-Yeon
Shin, Myung-Jun
Yu, Sun-ae
author_sort Yoo, Jeong-Eun
collection PubMed
description BACKGROUND: Cerebral palsy leads to many complications as well as delayed motor development, and early intensive rehabilitation in infancy, which is based on the theory of brain plasticity, is emphasized. In addition to conventional treatment, including physical, occupational, or speech-language therapies, children also have a demand for traditional Korean medicine interventions such as acupuncture or herbal medicine; however, a lack of evidence has made traditional Korean medicine difficult to implement in practice. We planned a multicentre, prospective, observational study to assess the effectiveness, safety and cost-effectiveness of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy. METHODS/DESIGN: Three hundred children with cerebral palsy aged 6 to 78 months will be recruited from six institutions. Data from each child are collected every month for a one-year period, during which time treatment might be changed or discontinued. A qualified investigator visits the sites to measure effectiveness variables, including Gross Motor Function Measure and Paediatric Evaluation of Disability Inventory. Adverse events and cost-effectiveness variables are collected using surveys conducted at baseline, mid-study, and end of study, as well as monthly tracking surveys. In the analyses, participants will be classified into two groups: group A children will be the conventional treatment group with physical, occupational, speech-language or other conventional rehabilitation therapies, whereas group B children will be the combination treatment group with traditional Korean medicine interventions, that is, herbal medicine, chuna, moxibustion and acupuncture, in addition to conventional treatment. DISCUSSION: Only a few clinical case reports have evaluated the effectiveness and safety of traditional Korean medicine; therefore, more data are required to provide optimal information to children with cerebral palsy and their guardians. We hypothesized that traditional Korean medicine combination treatment for children with cerebral palsy would have benefits compared with conventional therapy alone. The findings of this study might provide informative data for conducting economic evaluations and developing clinical research on combination treatment for cerebral palsy in South Korea. TRIAL REGISTRATION: NCT02223741
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spelling pubmed-48979052016-06-09 Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy Yoo, Jeong-Eun Yun, Young-Ju Shin, Yong-Beom Kim, Nam-kwen Kim, Soo-Yeon Shin, Myung-Jun Yu, Sun-ae BMC Complement Altern Med Study Protocol BACKGROUND: Cerebral palsy leads to many complications as well as delayed motor development, and early intensive rehabilitation in infancy, which is based on the theory of brain plasticity, is emphasized. In addition to conventional treatment, including physical, occupational, or speech-language therapies, children also have a demand for traditional Korean medicine interventions such as acupuncture or herbal medicine; however, a lack of evidence has made traditional Korean medicine difficult to implement in practice. We planned a multicentre, prospective, observational study to assess the effectiveness, safety and cost-effectiveness of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy. METHODS/DESIGN: Three hundred children with cerebral palsy aged 6 to 78 months will be recruited from six institutions. Data from each child are collected every month for a one-year period, during which time treatment might be changed or discontinued. A qualified investigator visits the sites to measure effectiveness variables, including Gross Motor Function Measure and Paediatric Evaluation of Disability Inventory. Adverse events and cost-effectiveness variables are collected using surveys conducted at baseline, mid-study, and end of study, as well as monthly tracking surveys. In the analyses, participants will be classified into two groups: group A children will be the conventional treatment group with physical, occupational, speech-language or other conventional rehabilitation therapies, whereas group B children will be the combination treatment group with traditional Korean medicine interventions, that is, herbal medicine, chuna, moxibustion and acupuncture, in addition to conventional treatment. DISCUSSION: Only a few clinical case reports have evaluated the effectiveness and safety of traditional Korean medicine; therefore, more data are required to provide optimal information to children with cerebral palsy and their guardians. We hypothesized that traditional Korean medicine combination treatment for children with cerebral palsy would have benefits compared with conventional therapy alone. The findings of this study might provide informative data for conducting economic evaluations and developing clinical research on combination treatment for cerebral palsy in South Korea. TRIAL REGISTRATION: NCT02223741 BioMed Central 2016-06-08 /pmc/articles/PMC4897905/ /pubmed/27267182 http://dx.doi.org/10.1186/s12906-016-1161-6 Text en © Yoo et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Yoo, Jeong-Eun
Yun, Young-Ju
Shin, Yong-Beom
Kim, Nam-kwen
Kim, Soo-Yeon
Shin, Myung-Jun
Yu, Sun-ae
Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title_full Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title_fullStr Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title_full_unstemmed Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title_short Protocol for a prospective observational study of conventional treatment and traditional Korean medicine combination treatment for children with cerebral palsy
title_sort protocol for a prospective observational study of conventional treatment and traditional korean medicine combination treatment for children with cerebral palsy
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4897905/
https://www.ncbi.nlm.nih.gov/pubmed/27267182
http://dx.doi.org/10.1186/s12906-016-1161-6
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