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

ABSTRACT: 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.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.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.NCT02223741.

SUBMITTER: Yoo JE

PROVIDER: S-EPMC4897905 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature

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

Yoo Jeong-Eun JE Yun Young-Ju YJ Shin Yong-Beom YB Kim Nam-Kwen NK Kim Soo-Yeon SY Shin Myung-Jun MJ Yu Sun-Ae SA

BMC complementary and alternative medicine 20160608

<h4>Background</h4>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 diffic ...[more]

PMID: 27267182

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Project description:In Korea, patients with mild cognitive impairment can choose to receive treatment of Korean medicine, and Korean medicine hospitals provide specialized medical care for the prevention and management of cognitive disorders. The aim of the study is to explore the role of Korean medicine therapy for patients with mild cognitive impairment in a real clinical setting. Fifteen patients with amnestic mild cognitive impairment were enrolled in this prospective observational study in three Korean medicine hospitals. Korean medicine treatments were delivered by experienced professionals and not restricted to standardized treatment. Outcome measures were prospectively planned to examine the Korean-Montreal Cognitive Assessment (K-MoCA), Korean-Mini Mental State Examination (K-MMSE), and other detailed neuropsychological assessment at the baseline and after 12 and 24 weeks of treatment. Korean medicine treatment for MCI treatment in the real-world clinical setting included herbal medicine and acupuncture. The most frequently used herbs in herbal decoctions were Acori Graminei Rhizoma, Polygalae Radix, and Poria Sclerotium Cum Pini Radix. The herbal medicine formulae used in this study were classified into three categories: tonifying Qi (33.3%), tonifying kidney (46.7%), and calming liver (20%) formulae. In the cognitive ability assessment, the K-MoCA score significantly improved after treatment (mean difference 2.6; 95% CI: 1.3 to 3.9, p=0.001). The K-MMSE score slightly increased after treatment; however, the improvement was not statistically significant (mean difference 0.8; 95% CI: -0.5 to 2.0, p=0.195). In detailed neuropsychological assessment, the cognitive domains of executive functions and memory after the treatment were distinctively improved. In this prospective observational case series, we could see the real clinical environments of treating patients with mild cognitive impairment in Korean medicine hospitals. Patients treated with Korean medicine showed improved results in the neuropsychological assessment after 12 and 24 weeks.

Project description:Background In Korea, conventional medicine (CM) and traditional Korean medicine (KM) are run as a dual healthcare system; however, the backgrounds and characteristics of the users of both medical services have not yet been compared. This study aimed to identify the differences in factors determining the use of CM and KM health services. Methods A secondary data analysis of a nationwide cross-sectional survey was conducted in this study. The Survey on the Experience with Healthcare Services 2017 asked participants about their most recent outpatient visit to a health service. Initially, a descriptive analysis was performed on respondents who visited the CM or KM health service in the last 12 months. Then, logistic regression analysis using Andersen’s behavioral model was performed, to identify the factors affecting health service selection, by classifying demographic variables into predisposing, enabling, and need factors. Respondents who replied they did not frequently use CM/KM and those with missing data were excluded. Results Of the total 11,098 respondents, 7,116 (64.1%) reported to have used CM/KM: 2,034 (18.3%), 4,475 (40.3%), and 607 (5.5%) for hospital CM, clinic CM, and KM, respectively. In logistic regression analysis, of the 2,723 (24.5%) respondents analyzed, 822 (7.4%) went to a hospital, 1,689 (15.2%) to a clinic, and 212 (1.9%) opted for KM service. Respondents with a higher number of chronic diseases were less likely to use KM (one disease, odds ratio: 0.52, 95% confidence interval: 0.36–0.76; two diseases: 0.51, 0.31–0.85; three to five diseases: 0.26, 0.10–0.69). Respondents with a high income were likely to go to the hospital (4Q vs. 1Q: 1.92, 1.35–2.72) and less likely to go to the clinic (4Q vs. 1Q: 0.49, 0.35–0.68). Conclusions Significant differences were observed on the enabling factor (income) for CM and need factors (number of chronic diseases) for KM. Our analysis suggests that through the healthcare policy, we should consider stratifying user backgrounds and needs for each medical service. Supplementary Information The online version contains supplementary material available at 10.1186/s12906-022-03641-x.

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

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

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