Remote Neurobased Approach to Aphasia Therapy

NCT05274360 | Completed

• 1 other identifier: RNAAT2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphasia, Broca; Aphasia, Wernicke; Aphasia, Fluent; Aphasia, Nonfluent; Aphasia

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (9)

• 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)

• 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)

• 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.

• 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.

• Amount and time of use

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

Study Arms (2)

Experimental Group

EXPERIMENTAL

Mobile evidence-based aphasia therapy

Behavioral: Mobile evidence-based aphasia therapy

Control Group

ACTIVE COMPARATOR

Conventional aphasia therapy

Behavioral: Conventional aphasia rehabilitation

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Institute for Bioengineering of Catalonia - Specs Lab

Barcelona, 08930, Spain

Location

Related Publications (26)

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MeSH Terms

Conditions

Aphasia, Broca; Aphasia, Wernicke; Aphasia

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: March 10, 2022
• Study Start: November 29, 2021
• Primary Completion: December 16, 2021
• Study Completion: December 29, 2021
• Last Updated: March 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)