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Remote Neurobased Approach to Aphasia Therapy (RNAAT)

Primary Purpose

Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mobile evidence-based aphasia therapy
Conventional aphasia rehabilitation
Sponsored by
Institute for Bioengineering of Catalonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia, Broca

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute for Bioengineering of Catalonia - Specs Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Mobile evidence-based aphasia therapy

Conventional aphasia therapy

Outcomes

Primary Outcome Measures

Within-group changes of language function
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.
Within-group changes of communication
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 Outcome Measures

Between-group change of language function
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.
Between-group change of communication
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.
Validation of usability of the technologies used
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.
Validation of usability, acceptability, and usefulness of the technologies used
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.
Amount and time 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.
Cues used per practice session
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.
Reaction time on tasks in the application
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.
Subjects' own validation score of voice recordings
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.
Risk assessment
A custom questionnaire will be used to measure any risks associated with the use of the application.

Full Information

First Posted
November 16, 2021
Last Updated
March 1, 2022
Sponsor
Institute for Bioengineering of Catalonia
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Universitat Pompeu Fabra
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1. Study Identification

Unique Protocol Identification Number
NCT05274360
Brief Title
Remote Neurobased Approach to Aphasia Therapy
Acronym
RNAAT
Official Title
Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 29, 2021 (Actual)
Primary Completion Date
December 16, 2021 (Actual)
Study Completion Date
December 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute for Bioengineering of Catalonia
Collaborators
Hospital Universitari Joan XXIII de Tarragona., Universitat Pompeu Fabra

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Broca, Aphasia, Wernicke, Aphasia, Fluent, Aphasia, Nonfluent, Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to either an experimental group or a control group. In the experimental group the participants will receive mobile-based aphasia therapy for two weeks. In the control group participants will receive no additional therapy apart from the conventional aphasia therapy that they are already receiving.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Mobile evidence-based aphasia therapy
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional aphasia therapy
Intervention Type
Behavioral
Intervention Name(s)
Mobile evidence-based aphasia therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional aphasia rehabilitation
Intervention Description
Control Group (conventional aphasia rehabilitation). No therapy as patients are in the chronic stage, where they do not receive healthcare rehabilitation training.
Primary Outcome Measure Information:
Title
Within-group changes of language function
Description
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.
Time Frame
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Title
Within-group changes of communication
Description
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.
Time Frame
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Secondary Outcome Measure Information:
Title
Between-group change of language function
Description
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.
Time Frame
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Title
Between-group change of communication
Description
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.
Time Frame
This will be assessed one day before starting the treatment and at the end of the treatment protocol (after two weeks)
Title
Validation of usability of the technologies used
Description
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.
Time Frame
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Title
Validation of usability, acceptability, and usefulness of the technologies used
Description
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.
Time Frame
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.
Title
Amount and time of use
Description
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.
Time Frame
This will be measured continuously through the use of the application during the two weeks of use.
Title
Cues used per practice session
Description
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.
Time Frame
This will be measured continuously through the use of the application during the two weeks of use.
Title
Reaction time on tasks in the application
Description
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.
Time Frame
This will be measured continuously through the use of the application during the two weeks of use.
Title
Subjects' own validation score of voice recordings
Description
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.
Time Frame
This will be measured continuously through the use of the application during the two weeks of use.
Title
Risk assessment
Description
A custom questionnaire will be used to measure any risks associated with the use of the application.
Time Frame
This will be assessed at the end of the treatment protocol (after two weeks) for the experimental group.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute for Bioengineering of Catalonia - Specs Lab
City
Barcelona
ZIP/Postal Code
08930
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Remote Neurobased Approach to Aphasia Therapy

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