Department of Korean Gynecology, CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-Do, South Korea.
Department of Integrative Medicine, School of Korean Medicine, Pusan National University, 20, Geumo-ro Mulgeum-eup, Yangsan-si Gyeongsangnam-do, 50612, Pusan, Republic of Korea.
Trials. 2020 Aug 17;21(1):723. doi: 10.1186/s13063-020-04639-x.
Traditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study.
Eighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events.
This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy.
Ministry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017.
传统的韩国医学（TKM）已在韩国用于治疗脑瘫儿童；然而，由于 TKM 对脑瘫患者的临床改善证据不足，TKM 联合常规康复（UR）治疗受到阻碍。在这项研究中，我们将通过随机对照临床试验来评估综合医学康复（IMR）治疗脑瘫的有效性和安全性。
将招募 80 名（2-6 岁）被诊断为脑瘫的儿童，并将其随机分为 A 组和 B 组。A 组患者接受 IMR 联合 UR 治疗，而 B 组患者在研究的第 1-12 周仅接受 UR 治疗。IMR 包括每周三次头部和四肢针灸治疗，以及同时与 UR 并行的草药（玉筋汤和玉屏风汤提取物）每天两次给药。评估将在研究开始时以及 12 周和 24 周（随访）进行。主要结局指标是粗大运动功能测量-88 评分，次要结局指标是目标达成量表、韩国贝利婴幼儿发育量表 III 和儿童生活质量量表评分，以及不良事件。
这将是首次在韩国评估 IMR 治疗脑瘫儿童的疗效和安全性的实用随机对照试验。研究结果将有助于证明 IMR 是否是脑瘫的有效治疗方法。
食品和药物安全部 31361（http://www.mfds.go.kr）。注册于 2017 年 6 月 29 日。临床研究信息服务 KCT0002620（https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819）。注册于 2017 年 12 月 29 日。
