title: The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI.
  
  
  METHODS
  A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period).
  
  
  CONCLUSIONS
  This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages.
  
  
  BACKGROUND
  This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. jasmine1874@163.com.|Fujian Key Laboratory of Exercise Rehabilitation, No. 282 WUSI Road, Gulou, Fuzhou, 350003, China. jasmine1874@163.com.|National Rehabilitation Research Center of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. jasmine1874@163.com.
authors.forename: Jia
authors.initials: J
authors.lastname: Huang
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. yushu_860223@163.com.
authors.forename: Zhengkun
authors.initials: Z
authors.lastname: Lin
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. wangqin_8808@163.com.
authors.forename: Qin
authors.initials: Q
authors.lastname: Wang
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 591417095@qq.com.
authors.forename: Feiwen
authors.initials: F
authors.lastname: Liu
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 1773903011@qq.com.
authors.forename: Jiao
authors.initials: J
authors.lastname: Liu
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 1938655280@qq.com.
authors.forename: Yunhua
authors.initials: Y
authors.lastname: Fang
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 946227821@qq.com.
authors.forename: Shanjia
authors.initials: S
authors.lastname: Chen
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 644493290@qq.com.
authors.forename: Xiaoxuan
authors.initials: X
authors.lastname: Zhou
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 568703596@qq.com.
authors.forename: Wenjun
authors.initials: W
authors.lastname: Hong
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. 61102547@qq.com.
authors.forename: Jinsong
authors.initials: J
authors.lastname: Wu
authors.affiliation: Friedrich-Alexander University Erlangen-Nuremberg, Schlossplatz 4, 91054, Erlangen, Germany. natalia.madrigal@fau.de.
authors.forename: Natalia
authors.initials: N
authors.lastname: Madrigal-Mora
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. zhgh_1969@aliyun.com.
authors.forename: Guohua
authors.initials: G
authors.lastname: Zheng
authors.affiliation: Fujian University of Traditional Chinese Medicine Subsidiary Rehabilitation Hospital, No. 282 WUSI Road, Gulou, Fuzhou, 350003, China. 49688400@qq.com.
authors.forename: Shanli
authors.initials: S
authors.lastname: Yang
authors.affiliation: College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. taojing01@163.com.|Fujian Key Laboratory of Exercise Rehabilitation, No. 282 WUSI Road, Gulou, Fuzhou, 350003, China. taojing01@163.com.|National Rehabilitation Research Center of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. taojing01@163.com.
authors.forename: Jing
authors.initials: J
authors.lastname: Tao
authors.affiliation: Fujian Key Laboratory of Exercise Rehabilitation, No. 282 WUSI Road, Gulou, Fuzhou, 350003, China. lidianchen87@163.com.|National Rehabilitation Research Center of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. lidianchen87@163.com.|Fujian University of Traditional Chinese Medicine, No. 1 Huatuo Road Shangjie Minhou, Fuzhou, 350122, China. lidianchen87@163.com.
authors.forename: Lidian
authors.initials: L
authors.lastname: Chen
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects / Q000191:economics; D002681:China; D002985:Clinical Protocols; D003071:Cognition; D003072:Cognition Disorders / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000534:rehabilitation*; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D006801:Humans; D011446:Prospective Studies; D012107:Research Design; D016037:Single-Blind Method; D020521:Stroke / Q000175:diagnosis / Q000191:economics / Q000523:psychology; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome