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 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
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.


CONCLUSIONS
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.


BACKGROUND
NCT02223741.
Dunsan Korean Medicine Hospital of Daejeon University, Daejeon, South Korea.
Jeong-Eun
JE
Yoo
Department of Integrative Medicine, School of Korean Medicine, Pusan National University, 20 Geumo-ro, Yangsan, 626-789, Gyeongnam, South Korea. mdkmdyun@pusan.ac.kr.
Young-Ju
YJ
Yun
Department of Rehabilitation Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Pusan, South Korea.
Yong-Beom
YB
Shin
Center for Comparative Effectiveness Research & Economic Evaluation in Korean Medicine, Pusan National University, Yangsan, South Korea.
Nam-Kwen
NK
Kim
Department of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, South Korea.
Soo-Yeon
SY
Kim
Department of Rehabilitation Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Pusan, South Korea.
Myung-Jun
MJ
Shin
Ulsan Korean Medicine Hospital of Dongeui University, Ulsan, South Korea.
Sun-Ae
SA
Yu
D002547:Cerebral Palsy / Q000191:economics / Q000628:therapy*; D002675:Child, Preschool; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D017048:Health Care Costs; D006801:Humans; D007223:Infant; D055670:Medicine, Korean Traditional; D010043:Outcome and Process Assessment, Health Care; D011446:Prospective Studies
Cerebral palsy; Gross Motor Function Measure (GMFM); Paediatric Evaluation of Disability Inventory (PEDI); Rehabilitation; Traditional Korean medicine (TKM)