Remote Neurobased Approach to Aphasia Therapy (RNAAT)

Institute for Bioengineering of Catalonia

Status: Completed

Conditions: Aphasia, Nonfluent; Aphasia, Wernicke; Aphasia, Fluent; Aphasia; Aphasia, Broca

Treatments: Behavioral: Mobile evidence-based aphasia therapy; Behavioral: Conventional aphasia rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05274360

RNAAT2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Mobile evidence-based aphasia therapy

Treatment:

Behavioral: Mobile evidence-based aphasia therapy

Control Group

Active Comparator group

Description:

Conventional aphasia therapy

Treatment:

Behavioral: Conventional aphasia rehabilitation