Prospective, Randomized, Clinical & Experimental Controlled Noninvasive Study for Neolexon® Aphasia-App in Acute Aphasia After Stroke
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- AABT
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Neolexon Therapy
Intervention: Neolexon (Device)
Neolexon Therapy
Intervention: Self training (Other)
Standard logopedic therapy
Intervention: Speech therapy (Other)
Standard logopedic therapy
Intervention: Self training (Other)
Outcomes
Primary Outcomes
AABT
Time Frame: 3 months
Aachener Aphasie Bedside Test
BI
Time Frame: 3 months
Barthel Index
Epidemiologic Data
Time Frame: 3 months
age, etiology of stroke, symptoms of stroke, specific stroke therapy (i.e. intravenous thrombolysis/recanalisation),
p-mRS
Time Frame: 3 months
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".
mRS
Time Frame: 3 months
1. Modified Rankin Scale (mRS): It is a Scoring System , which objectively quantifies disability after stroke in daily activities. 2. Scoring http://www.strokecenter.org/wp-content/uploads/2011/08/modified_rankin.pdf 3. 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. 4. It is summed.
LAST
Time Frame: 3 months
Language Screening Test
NIHSS
Time Frame: 3 months
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.
ACL
Time Frame: 3 months
Aphasie Check Liste
Secondary Outcomes
- EQ-5D-5L(3 months)
- BDI(3 months)
Investigators
Lars Kellert
Principal Investigator
Ludwig-Maximilians - University of Munich