Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study
Rationale: Treatment of aphasia is still challenging for clinicians and patients. So far, there is proven evidence for “face-to-face” speech therapy. However, the digital age potentially offers new and complementary strategies that may add to treatment outcome in a cost-effective way. Neolexon® is a...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-04-01
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| Series: | Frontiers in Neurology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fneur.2020.00294/full |
| _version_ | 1817986087148060672 |
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| author | Dennis C. Thunstedt Peter Young Clemens Küpper Katharina Müller Regina Becker Franziska Erbert Franziska Erbert Katharina Lehner Katharina Lehner Marika Rheinwald Marika Rheinwald Angelika Pfahler Marianne Dieterich Marianne Dieterich Marianne Dieterich Lars Kellert Katharina Feil |
| author_facet | Dennis C. Thunstedt Peter Young Clemens Küpper Katharina Müller Regina Becker Franziska Erbert Franziska Erbert Katharina Lehner Katharina Lehner Marika Rheinwald Marika Rheinwald Angelika Pfahler Marianne Dieterich Marianne Dieterich Marianne Dieterich Lars Kellert Katharina Feil |
| author_sort | Dennis C. Thunstedt |
| collection | DOAJ |
| description | Rationale: Treatment of aphasia is still challenging for clinicians and patients. So far, there is proven evidence for “face-to-face” speech therapy. However, the digital age potentially offers new and complementary strategies that may add to treatment outcome in a cost-effective way. Neolexon® is a commercial tablet-based software for treatment of aphasia, which can be applied with the help of a therapist or as self-training by the patient.Aims and hypothesis: In the Lexi study, we aim to determine whether treatment with Neolexon® is superior to standard therapy in acute post-stroke aphasia.Sample size estimates: A sample size of 180 patients, 90 for each group, will be included with an assumed dropout rate of ~20%.Methods and design: Prospective, randomized, parallel group, open-label, blinded-endpoint clinical, and experimental controlled non-invasive trial (PROBE). Adult German native speakers with acute aphasia after stroke are included. Computer-generated, blocked, and stratified randomization by aphasia severity will assign patients to one of two groups: 4 weeks of either standard logopedic speech therapy or logopedic speech therapy with the app version of Neolexon®. Both groups will be instructed in self-training: the frequency and duration of self-training will be documented. Screening for aphasia will be performed using the Language Screening Test (LAST). The severity of aphasia in general and in subitems will be assessed using the Bielefelder Aphasie Screening (BIAS) and the Aphasia Check List (ACL). Follow-up will be assessed after 3 months.Study outcomes: Based on the consensus in our study team, we considered a 10% mean difference in the change of percentile rank (PR) of BIAS to be a minimal and clinically important difference. The primary endpoint is defined as a significant difference in BIAS comparing the two groups. Differences in quality of life, Beck Depression Inventory (BDI), and modified Ranking Scale (mRS) will be evaluated as secondary outcome parameters.Discussion: This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy. Subgroups with the greatest response to Neolexon® will be described. The trial was prospectively registered on the “EU Clinical Trials Register” (NCT04080817)1. |
| first_indexed | 2024-04-14T00:04:57Z |
| format | Article |
| id | doaj.art-7b00e0c19a754337b2ac4ba2afa40521 |
| institution | Directory Open Access Journal |
| issn | 1664-2295 |
| language | English |
| last_indexed | 2024-04-14T00:04:57Z |
| publishDate | 2020-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Neurology |
| spelling | doaj.art-7b00e0c19a754337b2ac4ba2afa405212022-12-22T02:23:33ZengFrontiers Media S.A.Frontiers in Neurology1664-22952020-04-011110.3389/fneur.2020.00294526462Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi StudyDennis C. Thunstedt0Peter Young1Clemens Küpper2Katharina Müller3Regina Becker4Franziska Erbert5Franziska Erbert6Katharina Lehner7Katharina Lehner8Marika Rheinwald9Marika Rheinwald10Angelika Pfahler11Marianne Dieterich12Marianne Dieterich13Marianne Dieterich14Lars Kellert15Katharina Feil16Department of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyDepartment of Neurology, Medical Park Bad Feilnbach, Reithofpark, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyClinic for Orthopedic Surgery, Physical Medicine and Rehabilitation, Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyClinic for Orthopedic Surgery, Physical Medicine and Rehabilitation, Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyClinic for Orthopedic Surgery, Physical Medicine and Rehabilitation, Munich, GermanyDepartment of Neurology, Medical Park Bad Feilnbach, Reithofpark, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyGerman Center for Vertigo and Balance Disorders, Ludwig Maximilians University (LMU), Munich, GermanyMunich Cluster for Systems Neurology (SyNergy), Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyDepartment of Neurology, Ludwig Maximilians University (LMU), Munich, GermanyRationale: Treatment of aphasia is still challenging for clinicians and patients. So far, there is proven evidence for “face-to-face” speech therapy. However, the digital age potentially offers new and complementary strategies that may add to treatment outcome in a cost-effective way. Neolexon® is a commercial tablet-based software for treatment of aphasia, which can be applied with the help of a therapist or as self-training by the patient.Aims and hypothesis: In the Lexi study, we aim to determine whether treatment with Neolexon® is superior to standard therapy in acute post-stroke aphasia.Sample size estimates: A sample size of 180 patients, 90 for each group, will be included with an assumed dropout rate of ~20%.Methods and design: Prospective, randomized, parallel group, open-label, blinded-endpoint clinical, and experimental controlled non-invasive trial (PROBE). Adult German native speakers with acute aphasia after stroke are included. Computer-generated, blocked, and stratified randomization by aphasia severity will assign patients to one of two groups: 4 weeks of either standard logopedic speech therapy or logopedic speech therapy with the app version of Neolexon®. Both groups will be instructed in self-training: the frequency and duration of self-training will be documented. Screening for aphasia will be performed using the Language Screening Test (LAST). The severity of aphasia in general and in subitems will be assessed using the Bielefelder Aphasie Screening (BIAS) and the Aphasia Check List (ACL). Follow-up will be assessed after 3 months.Study outcomes: Based on the consensus in our study team, we considered a 10% mean difference in the change of percentile rank (PR) of BIAS to be a minimal and clinically important difference. The primary endpoint is defined as a significant difference in BIAS comparing the two groups. Differences in quality of life, Beck Depression Inventory (BDI), and modified Ranking Scale (mRS) will be evaluated as secondary outcome parameters.Discussion: This trial will determine whether speech therapy with the use of Neolexon® is superior to standard logopedic therapy. Subgroups with the greatest response to Neolexon® will be described. The trial was prospectively registered on the “EU Clinical Trials Register” (NCT04080817)1.https://www.frontiersin.org/article/10.3389/fneur.2020.00294/fullacute aphasiaischemic strokehemorrhagic strokeacute stroketablet-based therapyspeech therapy |
| spellingShingle | Dennis C. Thunstedt Peter Young Clemens Küpper Katharina Müller Regina Becker Franziska Erbert Franziska Erbert Katharina Lehner Katharina Lehner Marika Rheinwald Marika Rheinwald Angelika Pfahler Marianne Dieterich Marianne Dieterich Marianne Dieterich Lars Kellert Katharina Feil Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study Frontiers in Neurology acute aphasia ischemic stroke hemorrhagic stroke acute stroke tablet-based therapy speech therapy |
| title | Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study |
| title_full | Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study |
| title_fullStr | Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study |
| title_full_unstemmed | Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study |
| title_short | Follow-Up in Aphasia Caused by Acute Stroke in a Prospective, Randomized, Clinical, and Experimental Controlled Noninvasive Study With an iPad-Based App (Neolexon®): Study Protocol of the Lexi Study |
| title_sort | follow up in aphasia caused by acute stroke in a prospective randomized clinical and experimental controlled noninvasive study with an ipad based app neolexon r study protocol of the lexi study |
| topic | acute aphasia ischemic stroke hemorrhagic stroke acute stroke tablet-based therapy speech therapy |
| url | https://www.frontiersin.org/article/10.3389/fneur.2020.00294/full |
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