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

Abstract

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 Thunstedt et al. The Tablet-Based Lexi Study 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 .

Transcranial Direct-Current Stimulation as an Adjunct to Verb Network Strengthening Treatment in Post-stroke Chronic Aphasia: A Double-Blinded Randomized Feasibility Study

“… A, active tDCS; S, sham; M, male; F, female; HADS-A, Hospital Anxiety and Depression Scale-anxiety subscale; HADS-D, Hospital Anxiety and Depression Scale-Depression subscale; MOCA, The Montreal Cognitive Assessment. Severity of aphasia identified using Language Screening Test scores ( 32 , 33 ), scores of 0–5/15 = severe, 6–10/15 = moderate, 11–14/15 = mild . …”

“…Six community-dwelling participants with post-stroke chronic aphasia were recruited from community stroke support and communication groups, and community posters between November 2019 and February 2020. Participant inclusion criteria were: (a) mild-moderate aphasia caused by a single stroke, identified by using the Language Screening Test ( 32 , 33 ) (scores of 0–5/15 = severe, 6–10/15 = moderate, 11–14/15 = mild); (b) ≥ 6 months post onset (c) ≥18 years old; (d) English as a primary language; (e) right handed prior to stroke; (f) normal aided or unaided visual acuity; (g) and willing to participate and comply with the proposed block of intervention and testing regime. Exclusion criteria were persons with (a) neurological symptoms or history of a neurological event other than stroke; (b) history of more than one stroke (c) contraindications to tDCS (i.e., history of seizures, pacemakers); (d) global/severe aphasia, as the language intervention in the study required a higher level of comprehension than is usually observed in people with severe or global aphasia ( 34 ) (e) cognitive impairment as identified by a score <23/30 for the Montreal Cognitive Assessment ( 35 ); (f) left-handed dominance prior to stroke; (g) visual problems which interfere with persons' ability to access visual materials (i.e., pictures); (h) inability to attend sessions; (i) English as a second language; (j) and persons who were currently receiving SLT or taking part in a similar study.…”

Digitale Technik für ambulante Pflege und Therapie

“…Überdies stehen mittlerweile für den deutschsprachigen Raum Apps zur Verfügung, die Menschen mit Aphasie oder Dysarthrie für ein ergänzendes Eigentraining nutzen können, um die Therapiefrequenz zu erhöhen und damit den Rehabilitationserfolg zu verbessern (Frieg et al 2017; Späth/Haas/Jakob 2017; Jakob/Görtz/Späth 2018; Meyer/Bilda 2017). Eine randomisiert-kontrollierte Studie zur Untersuchung der Effektivität eines appbasierten Trainings ist bereits präregistriert (Thunstedt et al 2020).…”

“…Die Analyse von Real World Data bestätigt die Verbesserungen im Übungsverlauf (Jakob et al 2021). Eine randomisierte kontrollierte Studie, in der der Einsatz von neolexon mit Standardtherapie verglichen werden soll, wurde jedoch bereits präregistriert (Thunstedt et al 2020). Da die Auswahl der Übungen im Rahmen der Nutzung von Physiotec den Therapeut*innen ohne Empfehlungen überlassen wird, ist eine Evaluation der Wirksamkeit ohnehin nur für Übungskombinationen und nicht für die gesamte App möglich.…”

Digital participation of brain tumour patients in the assessment and treatment of communication disorders

“…Over the recent years, a still very limited number of digital speech and language therapy tools have been reported for use in this context, beyond the pure telemedicine approach of conducting patient visits via video call, e.g., the LingoTalk app (Heide et al, 2023 ), the neolexon apps (Thunstedt et al, 2020 ), the Constant Therapy (Braley et al, 2021 ), and the ORLA (Cherney et al, 2021 ) digital/computer programs, as well as more recent virtual technology approaches (e.g., Marshall et al, 2020 ; Repetto et al, 2021 ). Further promising tools are still in development or awaiting publication, e.g., the TELL (Corsten and Iserloh, n.d. ) and the Dysartrain (Klose and John, n.d. ) platforms for interactive digital speech and language therapy.…”