Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment
Phase: NA
Conditions: Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent, Aphasia, Nonfluent, Aphasia
Sponsor: Institute for Bioengineering of Catalonia

Remote Neurobased Approach to Aphasia Therapy
February 24, 2022

Study Protocol
Therapy will be administered to participants through a mobile application which all
participants in the experimental group will use at home for two weeks. Before starting the use,
pre-tests are conducted to determine the baseline scores of language function and
communication using the Barcelona test and the Communicative Activity Log. In the
introductory session, after the tests, the application is installed on the participant’s own phone
and the participant is given instructions and trained in how to use the application, before
starting their individual use of it at home. The therapist will prescribe use of the application 2
times per day for 20 minutes. Support is made available during the two weeks, if the
participant is having issues with the use of the application. Furthermore, all patients are
informed that they are allowed to receive help from family members or others in using the
application at home.
The participant is instructed to use the application two times every day for about twenty
minutes, but although this was the recommended use, the participant is free to use the
application when and for as long as they want. While using the app, the participant will,
through the app, be informed when they have been practicing for twenty minutes, in order to
limit their use to shorter but more frequent sessions. The practice consists of several different
tasks that are connected to different contexts from everyday life. The tasks consist of
matching visual objects, sounds, and short videos, as well as some written input of words. The
tasks also ask participants to record their voice saying the name of the object and to listen to
and evaluate their recording.
After two weeks, the participants will return and be given post-tests on the same measures as
before the start of the treatment, i.e., clinical scales for assessing language function and
communication. Additionally, they will complete two usability questionnaires (the System
Usability Scale and the mHealth App Usability Questionnaire), and a few questions regarding
risk assessment.
The control group will also receive the pre-tests on the first day and post-tests 14 days later.
They will not receive any treatment in that period, and they are not instructed to do or not to
do anything in particular while at home. This means that the control group participants will
proceed with their daily life as normally. The usability questionnaires will only be
administered to the experimental group, not to the control group.

Plan for Statistical Analysis
The analysis of the Barcelona test and the Communicative Activity Log (CAL) will consist
primarily of within-group analyses with the Wilcoxon rank sum test, because of the low
number of subjects. Additionally, linear mixed effects models will be used for the
between-group analyses, with the Barcelona Test and the CAL score for each domain (patient,
family, and therapist), respectively, as the dependent variable. The main independent variable
will be the pre-/post-test (time) through binary coding, as well as the control versus the
experimental group, including the interaction between the time variable and the group. The
participant ID will be included as random intercept in the model, to account for differences
between participants. The validity of the regression analysis will be evaluated by testing the
residuals of the model for normality using the Shapiro-Wilk test for normality. Given the low
number of subjects, the descriptive statistics will be reported with medians and quartiles, as
with non-parametric tests.
A descriptive analysis will be made of the SUS and MAUQ usability questionnaires to
determine the potential of a mobile application by drawing general conclusions from the use
of this specific application. These will be analysed with computation of overall scores and
examination of scores of different qualities of the application and use.
Further analysis will consist of descriptive statistics of the use of the application, e.g., amount
of use, reaction times, and recording length, for participants in the experimental groups. The
variables will be checked for normality with the Shapiro-Wilk test and depending on the
results either means and standard deviation or medians and quartiles will be reported. The use
measures will be analysed with t-tests or Wilcoxon rank sum tests to evaluate whether they
changed over time with the use of the application.
An additional analysis will be made of the score differences for the Barcelona test of the
experimental group, where the amount of use will be included in a linear regression model.
With the difference in test score as the dependent variable, the independent variables included
will be the total amount of use of the application. This analysis will evaluate whether the
amount of use influenced the outcome of the treatment.