title: 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.
abstract: BACKGROUND
  Stroke 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.
  
  
  METHODS
  A 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry: ChiCTR-TRC-13003704.
authors.forename: Shanli
authors.initials: S
authors.lastname: Yang
authors.forename: Haicheng
authors.initials: H
authors.lastname: Ye
authors.forename: Jia
authors.initials: J
authors.lastname: Huang
authors.forename: Jing
authors.initials: J
authors.lastname: Tao
authors.forename: Cai
authors.initials: C
authors.lastname: Jiang
authors.forename: Zhicheng
authors.initials: Z
authors.lastname: Lin
authors.forename: Guohua
authors.initials: G
authors.lastname: Zheng
authors.affiliation: Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China. lidianchen87@163.com.
authors.forename: Lidian
authors.initials: L
authors.lastname: Chen
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000293:Adolescent; D000328:Adult; D000368:Aged; D003072:Cognition Disorders / Q000209:etiology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D020521:Stroke / Q000523:psychology*; D000071939:Stroke Rehabilitation; D013813:Therapy, Computer-Assisted / Q000379:methods*; D016896:Treatment Outcome; D055815:Young Adult
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