Neolexon® Aphasia-App in Acute Aphasia After Stroke (Lexi)

Ludwig Maximilian University of Munich

Status: Unknown

Conditions: Stroke, Acute; Aphasia, Acquired

Treatments: Other: Self training; Other: Speech therapy; Device: Neolexon

Study type: Interventional

Funder types: Other

Identifiers

NCT04080817

19-068

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Neolexon Therapy

Experimental group

Treatment:

Other: Self training

Device: Neolexon

Standard logopedic therapy

Active Comparator group

Treatment:

Other: Self training

Other: Speech therapy