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Randomized Controlled Trial
. 2014 Dec 4;4(12):e007080.
doi: 10.1136/bmjopen-2014-007080.

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

Jianqiao Fang  1 , Lifang Chen  2 , Luni Chen  3 , Chao Wang  3 , Crystal Lynn Keeler  4 , Ruijie Ma  2 , Shouyu Xu  5 , Laihua Shen  6 , Yehua Bao  7 , Conghua Ji  8
Affiliations
Randomized Controlled Trial

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

Jianqiao Fang et al. BMJ Open. .

Abstract

Introduction: 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 and analysis: 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.

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 patients by telephone, during follow-up calls inquiring on patient'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.

Keywords: COMPLEMENTARY MEDICINE; STROKE MEDICINE.

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Figures

Figure 1
Figure 1
Route diagram of study design. IMR, integrative medicine rehabilitation; CR, conventional rehabilitation.
See this image and copyright information in PMC

References

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