Neolexon® Aphasia-App in Acute Aphasia After Stroke

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke

Conditions
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Aphasia, Acquired, Stroke, Acute

Intervention / Treatment
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* Device: Neolexon
* Other: Speech therapy
* Other: Self training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Acute Aphasia after stroke (ischemic oder hemorrhagic) Life expectancy ≥ 1 year Informed consent (presumed) Mother tongue: german Exclusion Criteria: Age < 18 years Missing aphasia Life expectancy < 1 year Mother tongue: other then german

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neolexon Therapy<br> | Device: Neolexon<br>* Application (Neolexon) on Tablet. Same frequency & intensity as in the other interventions<br>Other: Self training<br>* Same frequency & intensity as in the other interventions<br>|
| Active Comparator: Standard logopedic therapy<br> | Other: Speech therapy<br>* standard logopedic speech therapy. Same frequency & intensity as in the other interventions<br>Other: Self training<br>* Same frequency & intensity as in the other interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epidemiologic Data | age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation), | 3 months | 
| NIHSS | 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. | 3 months | 
| p-mRS | 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. | 3 months | 
| mRS | Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability after stroke in daily activities. Scoring http://www.strokecenter.org/wp-content/uploads/2011/08/modified_rankin.pdf 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. It is summed. | 3 months | 
| BI | Barthel Index | 3 months | 
| LAST | Language Screening Test | 3 months | 
| AABT | Aachener Aphasie Bedside Test | 3 months | 
| ACL | Aphasie Check Liste | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D-5L | US 5-level EuroQol 5-dimensional questionnaire Its a scoring tool, which objectively quantfies life quality. It consists of two seperate parts. 2. I: Scoring the Descriptive System with five dimensions. Each dimension has 5 boxes. 1-5 are scored as 1-5. -> There should be only 1 response for each dimension, Missing values can be coded as '9'. Ambiguous values should be treated as missing values. Each health state is referred to in terms of a 5 digit code 11111 (best health state), 55555 (worst health state) II: Scoring the VAS (visual analogue scale): This scale is numbered from 0 to 100. (100 means the best health you can imagine. 0 means the worst health you can imagine.) An X should be marked in the scale and then the number into a box. (Missing values should be coded as '999'.) https://euroqol.org/docs/Sample_UK__English__EQ-5D-5L_Paper_Self_complete.pdf, https://apersu.ca/wp-content/uploads/2017/07/Measuring-and-valuing-health-using-the-EQ-5D.pdf | 3 months | 
| BDI | Beck Depression Inventory. A self-scoring tool to objectively count the severity of depressive symptoms consisting of 21 questions. Each question ranges from 0 to 3 points. Subscales are summed. Maximum score is possible at 63 (21x3) and minimal score being 0. Levels of Depression 1-10 These ups and downs are considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression Source: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=2ahUKEwjd3u362rvkAhVSZ1AKHZJ4CCAQFjABegQIABAC&url=https%3A%2F%2Fwww.enhertsccg.nhs.uk%2Fsites%2Fdefault%2Ffiles%2Fpathways%2FBeck%2527s%2520Depression%2520Inventory_0.docx&usg=AOvVaw3MwAYfr0zL21nK88Cn4VTG | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Aphasia, Speech therapy, Computer based