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RNAAT: Remote Neurobased Approach to Aphasia Therapy

Sponsor
Institute for Bioengineering of Catalonia (Other)
Overall Status
Completed
CT.gov ID
NCT05274360
Collaborator
Hospital Universitari Joan XXIII de Tarragona. (Other), Universitat Pompeu Fabra (Other)
15
Enrollment
1
Location
2
Arms
30
Actual Duration (Days)
15.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile evidence-based aphasia therapy
  • Behavioral: Conventional aphasia rehabilitation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Neuroscience-Based Aphasia Therapy Adapted to Remote, Mobile-Based Treatment
Actual Study Start Date :
Nov 29, 2021
Actual Primary Completion Date :
Dec 16, 2021
Actual Study Completion Date :
Dec 29, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Within-group changes of language function [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 [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 Outcome Measures

  1. Between-group change of language function [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute for Bioengineering of Catalonia - Specs Lab Barcelona Spain 08930

Sponsors and Collaborators

  • Institute for Bioengineering of Catalonia
  • Hospital Universitari Joan XXIII de Tarragona.
  • Universitat Pompeu Fabra

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Institute for Bioengineering of Catalonia
ClinicalTrials.gov Identifier:
NCT05274360
Other Study ID Numbers:
  • RNAAT2021
First Posted:
Mar 10, 2022
Last Update Posted:
Mar 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aphasia
Aphasia, Broca
Aphasia, Wernicke

Study Results

No Results Posted as of Mar 10, 2022