Huang Jia, McCaskey Michael A, Yang Shanli, Ye Haicheng, Tao Jing, Jiang Cai, Schuster-Amft Corina, Balzer Christian, Ettlin Thierry, Schupp Wilfried, Kulke Hartwig, Chen Lidian
College of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, No.1 Huatuo Road, Minhou District, Fuzhou, 350122, Fujian Province, China.
Research Department, Reha Rheinfelden, Salinenstrasse 98, 4310, Rheinfelden, Switzerland.
Trials. 2015 Dec 2;16:546. doi: 10.1186/s13063-015-1054-x.
A majority of stroke survivors present with cognitive impairments. Attention disturbance, which leads to impaired concentration and overall reduced cognitive functions, is strongly associated with stroke. The clinical efficacy of acupuncture with Baihui (GV20) and Shenting (GV24) as well as computer-assisted cognitive training in stroke and post-stroke cognitive impairment have both been demonstrated in previous studies. To date, no systematic comparison of these exists and the potential beneficial effects of a combined application are yet to be examined. The main objective of this pilot study is to evaluate the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The second objective is to test the effects of a combined cognitive intervention that incorporates computer-assisted cognitive training and acupuncture (ACoTrain).
METHODS/DESIGN: An international multicentre, single-blinded, randomised controlled pilot trial will be conducted. In a 1:1:1 ratio, 60 inpatients with post-stroke cognitive dysfunction will be randomly allocated into either the acupuncture group, the computer-assisted cognitive training group, or the ACoTrain group in addition to their individual rehabilitation programme. The intervention period of this pilot trial will last 4 weeks (30 minutes per day, 5 days per week, Monday to Friday). The primary outcome is the test battery for attentional performance. The secondary outcomes include the Trail Making Test, Test des Deux Barrages, National Institute of Health Stroke Scale, and Modified Barthel Index for assessment of daily life competence, and the EuroQol Questionnaire for health-related quality of life.
This trial mainly focuses on evaluating the effects of computer-assisted cognitive training compared to acupuncture on the outcomes of attention assessments. The results of this pilot trial are expected to provide new insights on how Eastern and Western medicine can complement one another and improve the treatment of cognitive impairments in early stroke rehabilitation. Including patients with different cultural backgrounds allows a more generalisable interpretation of the results but also poses risks of performance bias. Using standardised and well-described assessments, validated for each region, is pivotal to allow pooling of the data.
Clinical Trails.gov ID: NCT02324959 (8 December 2014).
大多数中风幸存者存在认知障碍。注意力障碍会导致注意力不集中和整体认知功能下降，与中风密切相关。先前的研究已证实针刺百会穴（GV20）和神庭穴（GV24）以及计算机辅助认知训练对中风及中风后认知障碍的临床疗效。迄今为止，尚未对二者进行系统比较，联合应用的潜在益处也有待研究。本初步研究的主要目的是评估计算机辅助认知训练与针刺疗法相比对注意力评估结果的影响。第二个目的是测试结合计算机辅助认知训练和针刺疗法（ACoTrain）的联合认知干预效果。
方法/设计：将开展一项国际多中心、单盲、随机对照试验。60名中风后认知功能障碍住院患者将按1:1:1的比例，在接受各自康复计划的基础上，随机分为针刺组、计算机辅助认知训练组或ACoTrain组。本试验的干预期为4周（每天30分钟，每周5天，周一至周五）。主要结局是注意力表现测试组。次要结局包括用于评估日常生活能力的连线测验、双栏测验、美国国立卫生研究院卒中量表和改良巴氏指数，以及用于评估健康相关生活质量的欧洲五维健康量表。
本试验主要聚焦于评估计算机辅助认知训练与针刺疗法相比对注意力评估结果的影响。预计本初步试验的结果将为中西医如何相互补充以及改善早期中风康复中认知障碍的治疗提供新见解。纳入不同文化背景的患者可使结果的解释更具普遍性，但也存在表现偏倚的风险。使用针对每个地区进行验证的标准化且详细描述的评估方法对于汇总数据至关重要。
Clinical Trails.gov标识符：NCT02324959（2014年12月8日）。
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