Remote Neurobased Approach to Aphasia Therapy (RNAAT)

March 1, 2022 updated by: Institute for Bioengineering of Catalonia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08930
        • Institute for Bioengineering of Catalonia - Specs Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Mobile evidence-based aphasia therapy
Behavioral: Mobile evidence-based aphasia therapy
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.
Active Comparator: Control Group
Conventional aphasia therapy
Behavioral: Conventional aphasia rehabilitation
Control Group (conventional aphasia rehabilitation). No therapy as patients are in the chronic stage, where they do not receive healthcare rehabilitation training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
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.
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
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.
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
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.
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
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.
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
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.
This will be measured continuously through the use of the application during the two weeks of use.
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.
This will be measured continuously through the use of the application during the two weeks of use.
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.
This will be measured continuously through the use of the application during the two weeks of use.
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.
This will be measured continuously through the use of the application during the two weeks of use.
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.
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Bioengineering of Catalonia

Collaborators

Hospital Universitari Joan XXIII de Tarragona.
Universitat Pompeu Fabra

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2021

Primary Completion (Actual)

December 16, 2021

Study Completion (Actual)

December 29, 2021

Study Registration Dates

First Submitted

November 16, 2021

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNAAT2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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