Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- AABT
研究概览
简要总结
Up to now there is proven evidence of traditional logopedic therapy in aphasia, but recent computer-based algorithms also showed their evidence so far. Due to small and heterogenous study populations further trials are urgently needed. This prospective, randomized, clinical & experimental controlled noninvasive study is intended to provide data for the therapy of an individual approach in aphasia patients.
详细描述
The prospective, randomized, clinical & experimental controlled noninvasive study (Lexi) is intended to start in 10/2019. Adult and German speaking patients suffering from aphasia after stroke who give informed consent and whose life expectancy is estimated above 1 year are included and will be followed up for 3 months. If informed consent is not available their legal guardian will have to provide written informed consent for their contribution.
After Randomization participants are divided into two different groups:
Patients receiving a standard logopedic speech treatment versus individuals working with a computer-based solution (Neolexon® App on mobile devices). Both groups will also have self-training and therefore frequency and intensity of this is also going to be analyzed as well as in the clinical surrounding.
There will be three different major ward rounds in both groups during the trial period where scales scoring the severity of aphasia are collected and compared (i.e. AABT or LAST).
Furthermore epidemiologic data and stroke scales (i.e. NIHSS, mRS) are evaluated. The last round will be the follow-up after 3 months. Lexi will provide new data to fill the gap of organizational barriers and structural problems. Our aim is to show modern alternative therapy algorithms that approach the individual problem to offer a potential tailored solution to patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Acute Aphasia after stroke (ischemic oder hemorrhagic)
- •Life expectancy ≥ 1 year
- •Informed consent (presumed)
- •Mother tongue: german
排除标准
- •Age < 18 years
- •Missing aphasia
- •Life expectancy < 1 year
- •Mother tongue: other then german
研究组 & 干预措施
Neolexon Therapy
干预措施: Neolexon (Device)
Neolexon Therapy
干预措施: Self training (Other)
Standard logopedic therapy
干预措施: Speech therapy (Other)
Standard logopedic therapy
干预措施: Self training (Other)
结局指标
主要结局
AABT
时间窗: 3 months
Aachener Aphasie Bedside Test
BI
时间窗: 3 months
Barthel Index
Epidemiologic Data
时间窗: 3 months
age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation),
p-mRS
时间窗: 3 months
premorbid Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability before stroke in daily activities. Same questions/scores as in "Outcome 4".
mRS
时间窗: 3 months
1. Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability after stroke in daily activities. 2. Scoring http://www.strokecenter.org/wp-content/uploads/2011/08/modified_rankin.pdf 3. There is only one total score. The minimum possible score is 0 and the maximum possible score is 6. A high score means worse prognosis/dead, low score indicates a good prognosis. 4. It is summed.
LAST
时间窗: 3 months
Language Screening Test
NIHSS
时间窗: 3 months
NIHSS "National Institutes of Health Stroke Scale". It is a Scoring System , which objectively quantifies severity of stroke based on weighted evaluation findings. Scoring: https://www.stroke.nih.gov/documents/NIH_Stroke_Scale.pdf Calculating/Interpreting: Higher Scores predict poor outcome and high severity of stroke. Low Scores are associated with minimal mortality and good prognosis. The minimum score being 0, and the maximum score being 42. Subscales are summed to a total Score (high score means worse prognosis, low score indicates a good prognosis.
ACL
时间窗: 3 months
Aphasie Check Liste
次要结局
- EQ-5D-5L(3 months)
- BDI(3 months)
研究者
Lars Kellert
Principal Investigator
Ludwig-Maximilians - University of Munich