The synergistic effect of acupuncture and computer-based cognitive training on post-stroke cognitive dysfunction: a study protocol for a randomized controlled trial of 2 × 2 factorial design

BMC Complementary and Alternative Medicine

Study Protocol

Guohua Zheng¹  Lidian Chen²  Zhicheng Lin³  Shanli Yang³  Haicheng Ye⁴  Jia Huang⁴  Cai Jiang⁴  Jing Tao⁴ 

[1] Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, 350122, Fuzhou, China;Fujian University of Traditional Chinese Medicine, 350122, Fuzhou, China;Rehabilitation Hospital Affiliated to Fujian University of TCM, 350003, Fuzhou, China;Rehabilitation Medicine College, Fujian University of Traditional Chinese Medicine, 350122, Fuzhou, China;

关键词: Acupuncture;    Computer-based cognitive training;    Stroke;    Cognitive dysfunction;   

DOI  :  10.1186/1472-6882-14-290

 received in 2014-05-17, accepted in 2014-07-30,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundStroke is one of the most common causes of cognitive impairment. Up to 75% of stroke survivors may be considered to have cognitive impairment, which severely limit individual autonomy for successful reintegration into family, work and social life. The clinical efficacy of acupuncture with Baihui (DU20) and Shenting (DU24) in stroke and post-stroke cognitive impairment has been previously demonstrated. Computer-assisted cognitive training is part of conventional cognitive rehabilitation and has also shown to be effective in improvement of cognitive function of affected patients. However, the cognitive impairment after stroke is so complexity that one single treatment cannot resolve effectively. Besides, the effects of acupuncture and RehaCom cognitive training have not been systematically compared, nor has the possibility of a synergistic effect of combination of the two therapeutic modalities been evaluated. Our primary aim of this trial is to evaluate the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke.Method/DesignA randomized controlled trial of 2 × 2 factorial design will be conducted in the Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine. A total of 240 patients with cognitive dysfunction after stroke who meet the eligibility criteria will be recruited and randomized into RehaCom training group, acupuncture group, a combination of both or control group in a 1:1:1:1 ratio. All patients will receive conventional treatment. The interventions will last for 12 weeks (30 min per day, Monday to Friday every week). Evaluations will be conducted by blinded assessors at baseline and again at 4, 8 and 12 weeks. Outcome measurements include mini–mental state examination (MMSE), Montreal cognitive assessments (MoCA), functional independence measure scale (FIM) and adverse events.DiscussionThe results of this trial are expected to clarify the synergistic effect of acupuncture and RehaCom cognitive training on cognitive dysfunction after stroke. Furthermore, to confirm whether combined or alone of acupuncture and RehaCom cognitive training, is more effective than conventional treatment in the management of post-stroke cognitive dysfunction.Trial registrationChinese Clinical Trial Registry: ChiCTR-TRC-13003704.Registration date: 4 September, 2013.

【 授权许可】

Unknown   
© Yang et al.; licensee BioMed Central Ltd. 2014. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.