Stroke, Acute Clinical Trial
— LexiOfficial title:
Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke
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.
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | February 1, 2020 |
Est. primary completion date | November 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Ludwig Maximilians University (LMU) Munich, Department of Neurology with Friedrich-Baur Institute | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Ludwig-Maximilians - University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epidemiologic Data | age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation), | 3 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | BI | Barthel Index | 3 months | |
Primary | LAST | Language Screening Test | 3 months | |
Primary | AABT | Aachener Aphasie Bedside Test | 3 months | |
Primary | ACL | Aphasie Check Liste | 3 months | |
Secondary | 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 | |
Secondary | 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 |
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