NCT02324959Unknown不适用
Evaluation of Acupuncture and Attention Training Effects on Patients After Stroke: a Study Protocol of an International Multicentre Study Using a Randomized Single Blinded Three-group Design
Fujian University of Traditional Chinese Medicine5 个研究点 分布在 3 个国家目标入组 60 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
研究概览
简要总结
The purpose of this study is to determine whether acupuncture and computer-based attention training can be combined for more effective post-stroke attentional deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to inpatient stroke rehabilitation within six months after first-ever stroke
- •Mild cognitive impairments (attention performance TAP > 1 standard deviation below mean age-matched norm in at least one subtest).
- •Conscious, stable physical condition and signed informed consent of patient.
排除标准
- •Severe visual and/or hearing problems
- •Inability to follow instructions (MoCA)
- •Disorders of speech and instruction comprehension (tested with a modified token-test)
- •Severe visual and/or hearing problems
- •Pre-existing mental disorders - Pregnancy
结局指标
主要结局
Change from Baseline in attention performance at 4 weeks (Test Battery for Attention Performance (TAP))
时间窗: Pretest (day 1), Posttest (4 weeks)
次要结局
- Change from Baseline in number of errors for the Test des Deux Barrage (T2B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
- Change from baseline in total score of Extended Barthel Index (EBI) at four weeks.(Pretest (day 1), Posttest (4 weeks))
- Change from Baseline in number of omissions for the Test des Deux Barrage (T2B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
- Change from Baseline in time needed for Trail Making Test (TMT A/-B) at four weeks.(Pretest (day 1), Posttest (4 weeks))
- National Institute of Health Stroke Scale (NIH-SS)(Pretest (day 1))
- Change from baseline score of EuroQol quality of life questionnaire (EQ-5D 3L) at four weeks.(Pretest (day 1), Posttest (4 weeks))
研究者
Shanli Yang
Dr.
Fujian University of Traditional Chinese Medicine
研究点 (5)
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