Integrative medicine for subacute XXXX rehabilitation: a study protocol for a multicentre, randomised, controlled trial.

@entity1 @entity64 @entity308
INTRODUCTION: Many @entity1 with @entity64 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 @entity64 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 @entity64 rehabilitation. METHODS AND ANALYSIS: 360 @entity1 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. @entity1 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 @entity64 Scale (NIHSS), Fugl-Meyer Assessment, the mini-mental state examination and Montreal Cognitive, Hamilton's @entity308 Scale and Self-Rating @entity308 Scale, and the incidence of adverse events. ETHICS AND DISSEMINATION: 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 @entity1 by telephone, during follow-up calls inquiring on @entity1 's post-study health status. TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Register: ChiCTR-TRC-12001972, http://www.chictr.org/en/proj/show.aspx?proj=2561.
