Skip to main content
OpenTrials
Completed

NCT Number: NCT05274360

Remote Neurobased Approach to Aphasia Therapy

The purpose of this study is the development and validation of an evidence-based mobile application, based on the core premises of Intensive Language-Action Therapy (ILAT) for aphasia, for the training and improvement of chronic aphasia patients administered at the patient's home. It aims at testing the beneficial effect on the linguistic performance (as assessed by the Barcelona and CAL clinical tests) counteracting learned non-use and the usability of the application as a tool for training once discharged from hospital care.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Bioengineering of Catalonia - Specs Lab

Barcelona, 08930, Spain

About this study

Acquired brain lesions such as stroke often result in the most common disabling neurological damages. Up to 42% of stroke patients suffer serious language deficits and patients are frequently left with chronic disabilities which adversely impact their quality of life. One of the main challenges in aphasia rehabilitation includes long-term effects. After a certain time (i.e., 3-6mo, chronic phase), the frequency of therapy will decrease or stop, even if the patient has not always reached the expected or desired level of recovery. After this, a body of evidence suggests that the person with aphasia might decrease the use of verbal language given the negative reinforcement when trying to use the deteriorated function and failing to achieve a successful communication. This might lead to relying on other forms of communication (e.g., gestures) and to a vicious cycle of deterioration of verbal skills known as Learned Non-Use principle. Together with the pandemic socioeconomic situation and limited resources at healthcare facilities, this calls for the need of effective and efficient interventions that can be deployed at the house of the patients, in the form of auto-administered therapy. Despite the limited exploration of portable technologies in aphasia recovery, their use has been extensive and successful in other domains such as motor rehabilitation. Importantly, patients with aphasia report that the number 1 topic they would like to know more about is how to keep recovering after therapy ends.

Following recent evidence on experience-dependent plasticity mechanisms for successful stroke recovery and well-established theory-grounded interventions, such as ILAT, the present study aims to study the usability and improvement potential of a mobile-based aphasia rehabilitation app for stroke patients, used at home. A previous collaboration between both centers (SPECS lab and Hospital Joan XIII) used a computer-based setup. In this study by Grechuta et al. (2019), the Rehabilitation Gaming System for aphasia (RGSa) shows positive significant results on language (P= 0.001) and communication (P<0.05) compared to conventional therapy in the long term (16 weeks). This study will assess the usability, risks, and clinical outcome of the same principles applied to a mobile application that is prescribed to be used at home for two twenty-minutes session per day during two weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with any type of aphasia
  • 6 or more months have passed since the stroke (chronic stage)
  • Age between 18 and 90 years

Exclusion criteria

  • Non-compliance with some of the inclusion criteria
  • Presence of major perceptual, cognitive, motor, cognitive or neuropsychological pathology that can interfere with aphasia or make it difficult to interact with the system, including severe forms of motor impairments and apraxia, visual processing deficits, planning deficits, learning deficits, memory deficits, or attentional deficits
  • Inability to understand the study participation
  • Patients with an Android phone or tablet

Treatment and study plan

Mobile evidence-based aphasia therapy

Behavioral

Use of mobile application to practice language for 2 weeks with a recommendation of 2 sessions per day of 20 minutes. The Android application, which is a Unity-based 2D game, will be installed on the patient's own phone, and they will play individually with the support of a family member if needed. The patients are free to start and stop using the application at any time. The application is safe to use, and it consists of therapeutic training methods such as object-matching, word search, writing, and manual voice recordings.

Conventional aphasia rehabilitation

Behavioral

Control Group (conventional aphasia rehabilitation). No therapy as patients are in the chronic stage, where they do not receive healthcare rehabilitation training.

Primary outcomes

  1. Within-group changes of language function

    Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)

    Clinical scale for language (Barcelona Test) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group.

    Scale from 0 (minimum) to 365 (maximum) where higher scores indicate a better outcome.

  2. Within-group changes of communication

    Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)

    Clinical scale for communication (Communicative Activity Log; Pulvermüller et al., 2001b) will be assessed at baseline T0 (prior to the use of the application) and T1 (after two weeks of use) for the experimental group.

    Scale from 0 (minimum) to 5 (maximum) where higher scores indicate a better outcome.

Secondary outcomes

  1. Between-group change of language function

    Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)

    Clinical scale for language (Barcelona Test) will be assessed at baseline T0 (time 0) and T1 (time 1).

    Scale from 0 (minimum) to 365 (maximum) where higher scores indicate a better outcome.

  2. Between-group change of communication

    Time frame: This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)

    Clinical scale for communication (Communicative Activity Log; Pulvermüller et al., 2001b) will be assessed at baseline T0 (time 0) and T1 (time 1).

    Scale from 0 (minimum) to 5 (maximum) where higher scores indicate a better outcome.

  3. Validation of usability of the technologies used

    Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.

    System Usability Scale (SUS) will be used as a measure of usability of the application.

    Scale from 1 (minimum) to 5 (maximum) where higher scores indicate a better outcome.

  4. Validation of usability, acceptability, and usefulness of the technologies used

    Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.

    mHealth App Usability Questionnaire (MAUQ) (Zhou, Bao, Setiawan, Saptono, & Parmanto, 2019) will be used as a measure of usability, acceptability, and usefulness of the application.

    Scale from 1 (minimum) to 7 (maximum), where higher scores indicate a better outcome.

  5. Amount and time of use

    Time frame: This will be measured continuously through the use of the application during the two weeks of use.

    Relationship between the total use of the application, measured in number of sessions and total time spent in minutes using the app, and improvement on the Barcelona test measured on scale from 0-365, where higher scores indicate a better outcome.

  6. Cues used per practice session

    Time frame: This will be measured continuously through the use of the application during the two weeks of use.

    Count of cues used by the subjects during the primary sessions of use of the application and compared to the final sessions of use of the application.

  7. Reaction time on tasks in the application

    Time frame: This will be measured continuously through the use of the application during the two weeks of use.

    Reaction time, measured in seconds, during the primary sessions of use of the application and compared to the final sessions of use of the application.

  8. Subjects' own validation score of voice recordings

    Time frame: This will be measured continuously through the use of the application during the two weeks of use.

    The validation score recorded from the application during the primary sessions of use of the application and compared to the final sessions of use of the application. Measured between 0 and 1 and represents the subject's score of how well they performed the task and recording.

  9. Risk assessment

    Time frame: This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.

    A custom questionnaire will be used to measure any risks associated with the use of the application.

Sponsors and collaborators

Lead sponsor

Institute for Bioengineering of Catalonia

Other

Collaborators

  • Hospital Universitari Joan XXIII de Tarragona.
  • Universitat Pompeu Fabra

Registry information

Official study title

Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment

Acronym: RNAAT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2022
Registry last updated
Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.