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临床试验/NCT03622411
NCT03622411
已完成
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The Effect of a Tablet-based Aphasia Therapy in the Chronic Phase After Stroke

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 15 人2018年9月7日
适应症AphasiaStroke

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Aphasia
发起方
University Hospital, Ghent
入组人数
15
试验地点
1
主要终点
Boston Naming Test (BNT)
状态
已完成
最后更新
3年前

概览

简要总结

Aphasia is one of the most common and disabling disorders following stroke, in many cases resolving in long-term deficits. There is evidence that intensive aphasia therapy is effective for language recovery, even in the chronic phase post-stroke. However, as many patients are left with residual language disorders and intensive aphasia rehabilitation is difficult to achieve, the investigators are exploring tablet-based therapies to further facilitate language recovery in a cost-effective manner.

详细描述

This study will investigate the clinical effects of intensive tablet-based aphasia therapy as an add-on to conventional aphasia therapy (= high intensive) compared to conventional aphasia therapy (either alone, or in combination with recreational tablet use (= low intensive) in patients with aphasia following stroke, as measured by specific linguistic tests, within task improvements, functional communication and quality of life. Furthermore, the investigators want to learn more about the recovery of specific underlying language processes via event-related potentials (ERPs). At last, the investigators aim to explore whether patients with aphasia are satisfied with a tablet-based aphasia therapy, whether the app is user-friendly and which barriers the participants might have encountered.

注册库
clinicaltrials.gov
开始日期
2018年9月7日
结束日期
2021年2月23日
最后更新
3年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • diagnosed with mild-severe aphasia (token test score between 7 and 49) after a left hemispheric ischemic or hemorrhagic stroke
  • inclusion starting from 6 months post-stroke
  • age 18 - 85 years
  • being right-handed (according to the questionnaire for handedness, Van Strien)
  • mother tongue: Dutch
  • imaging (CT or MRI) prior to inclusion
  • signed informed consent

排除标准

  • history of a previous stroke with persistent (\> 24 hours) language symptoms
  • history of other diseases of the central nervous system, psychological disorders and (developmental) speech and/or language disorders
  • serious non-linguistic, cognitive disorders (as documented in the patients' medical history)
  • inability to perform tablet-based tasks (based on a short training session)
  • excessive use of alcohol or drugs

结局指标

主要结局

Boston Naming Test (BNT)

时间窗: 4 months

Measure of word retrieval. Patients will have to name line drawings that gradually increase in difficulty

次要结局

  • Spontaneous speech of the Aachen Aphasia Test (AAT)(4 months)
  • Usability questionnaire(1 day)
  • Quality of life (SAQOL-39-Nl)(4 months)

研究点 (1)

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