title: Integrative medicine for subacute stroke rehabilitation: a study protocol for a multicentre, randomised, controlled trial.
abstract: BACKGROUND
  Many patients with stroke receive integrative medicine in China, which includes the basic treatment of Western medicine and routine rehabilitation, in conjunction with acupuncture and Chinese medicine. The question of whether integrative medicine is efficacious for stroke rehabilitation is still controversial and very little research currently exists on the integrated approach for this condition. Consequently, we will conduct a multicentre, randomised, controlled, assessor-blinded clinical trial to assess the effectiveness of integrative medicine on stroke rehabilitation.
  
  
  METHODS
  360 participants recruited from three large Chinese medical hospitals in Zhejiang Province will be randomly divided into the integrative medicine rehabilitation (IMR) group and the conventional rehabilitation (CR) group in a 1:1 ratio. Participants in the IMR group will receive acupuncture and Chinese herbs in addition to basic Western medicine and rehabilitation treatment. The CR group will not receive acupuncture and Chinese herbal medicine. The assessment data will be collected at baseline, 4 and 8 weeks postrandomisation, and then at 12 weeks' follow-up. The primary outcome is measured by the Modified Barthel Index. The secondary outcomes are the National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's Depression Scale and Self-Rating Depression Scale, and the incidence of adverse events.
  
  
  BACKGROUND
  Ethical approval was obtained from ethics committees of three hospitals. The results will be disseminated in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients by telephone, during follow-up calls inquiring on patient's post-study health status.
  
  
  BACKGROUND
  Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561.
authors.affiliation: Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Jianqiao
authors.initials: J
authors.lastname: Fang
authors.affiliation: Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Lifang
authors.initials: L
authors.lastname: Chen
authors.affiliation: The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Luni
authors.initials: L
authors.lastname: Chen
authors.affiliation: The Third Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Chao
authors.initials: C
authors.lastname: Wang
authors.affiliation: Department of Innovations to Wellness, Affiliated with Five Branches University, San Jose, California, USA.
authors.forename: Crystal Lynn
authors.initials: CL
authors.lastname: Keeler
authors.affiliation: Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Traditional Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Ruijie
authors.initials: R
authors.lastname: Ma
authors.affiliation: Department of Rehabilitation, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang, China.
authors.forename: Shouyu
authors.initials: S
authors.lastname: Xu
authors.affiliation: Department of Acupuncture & Encephalopathy, Jiaxing Hospital of Traditional Chinese Medicine, Jiaxing, Zhejiang, China.
authors.forename: Laihua
authors.initials: L
authors.lastname: Shen
authors.affiliation: Department of Acupuncture & Rehabilitation, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
authors.forename: Yehua
authors.initials: Y
authors.lastname: Bao
authors.affiliation: The Clinical Research Institute of Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
authors.forename: Conghua
authors.initials: C
authors.lastname: Ji
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use; D005260:Female; D006801:Humans; D055048:Integrative Medicine / Q000379:methods*; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal
keywords: COMPLEMENTARY MEDICINE; STROKE MEDICINE