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

Abstract

BackgroundCerebral 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/DesignThree 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.DiscussionOnly 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 registrationNCT02223741

Cerebral palsy information system with an approach to information architecture: a systematic review

“…A total of 39 articles on the components of CP information system architecture were reviewed, of which 13 had been conducted in Europe,23 26–37 10 in the USA,38–47 6 in Australia,48–53 7 in Asia1 12 54–58 and 3 in Africa 59–61…”

“…Twenty articles (51.28%) cited various international classifications of diseases, including ICD-10, International Classification of Functioning, Disability and Health (ICF), ICE-CY, Gross Motor Function Classification System (GMFCS) and Manual Ability Classification System (MACS), utilised for standardising datasets related to CP 1 23 27 28 36–41 43 44 46 49 50 54 57–59 61. The majority of cases were related to the use of ICF and GMFCS.…”

“…The necessity of controlling the quality of data generated in the information systems was highlighted in 10 articles (25.64%) 26 27 33 36 37 44 50 53 54 58. In seven articles (17.94%), the data producers were in charge of data quality control.…”

Complementary traditional Chinese medicine use in Children with cerebral palsy: a nationwide retrospective cohort study in Taiwan

“…Many parents and policy-makers concerned about the costs of complementary and alternative medicine for patients with CP [59, 60]. This study provided some substantial economic evaluation for the integration of TCM treatment into the clinical healthcare of CP.…”

Integrative Medicine for Postoperative Patients: A Survey of Korean Medicine Doctors

“…In addition, the KM hospitals particularly provide care for patients with musculoskeletal disorders in Korea and several US hospitals use integrative medicine for the treatment of patients with spinal disorders [5]. Clinical trials have also been conducted using different methodologies including the protocol for a prospective observational study using integrative medicine in children with cerebral palsy, protocol of three-armed randomized controlled trial for symptomatic lumbar spinal stenosis, and case series of prescribing herbal medicine and gefitinib for non-small-cell lung cancer patients [6–8]. …”