Virtual Reality Training for Aphasia Rehabilitation (Aphasia360)

March 17, 2026 updated by: Claudia Repetto, Catholic University of the Sacred Heart

Anomias Rehabilitation Training Through 360° Videos

Aphasia is an acquired deficit following acute damage to the central nervous system that involves the difficulty or impossibility of understanding and formulating language. A typical disorder of non-fluent forms of aphasia is anomia. Anomia refers to the difficulty in finding words, in particular when trying to name objects and actions. According to the Embodied Cognition approach (EC), language is tightly connected to the motor system. In this view, language rehabilitation programs should stimulate language through the activation of the motor system. In this approach, since anomic deficits are often due to a weak link between the meaning of the word and its lemma, the Hebbs' principles of coincident and correlated learning can be exploited, i.e., by intensifying the synchronous activation of lexicon and semantics and connecting them with the motor counterpart. In this study, the investigators present an innovative training, based on the EC framework, in which they will make use of new technologies for anomia rehabilitation in post-stroke patients. Specifically, the researchers will use immersive 360° videos representing everyday actions displayed from the first-person point of view, experienced through a head-mounted display. The training will be administered 3 times a week for 4 weeks. The control group will watch standard videos representing the same actions recorded from the third-person perspective. Naming abilities will be tested before and after the training together with other cognitive and psychological measures. The investigators expect that the group who will undergo the 360° video-based training will show greater improvement of performance compared to the control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Brescia
      • Brescia, Brescia, Italy, 25123
        • Poliambulanza

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • naming disorder in the post-acute phase (index event occurring at least 6 months earlier)
  • to have already received rehabilitation treatment in the acute phase
  • noun naming below cut-off
  • verbs naming below cut- off

Exclusion Criteria:

  • concomitant or pre-existing (with respect to the index event) neurological and psychiatric deficits
  • epilepsy
  • balance disorders
  • neglect

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video 360
Patients will watch spherical videos displaying everyday actions towards objects; an audio is embedded describing the action and the object represented (i.e. "I'm cutting the potatoes").
Behavioral: Video 360
Patients will undergo 12 sessions, 3 per weeks, 4 weeks
Active Comparator: Standard video
Patients will watch standard videos displaying everyday actions towards objects; an audio is embedded describing the action and the object represented (i.e. "I'm cutting the potatoes")
Behavioral: Standard videos
Patients will undergo 12 sessions, 3 per weeks, 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of verbs and objects correctly named
Time Frame: post treatment, 1 month
All the trained videos will be presented and the patient will be asked to name the verb and the object depicted. The accuracy will be registered
post treatment, 1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Batteria per l'Analisi dei Deficit Afasici (BADA), naming subtest
Time Frame: post treatment, 1 month
It is an Italian validated neuropsychological battery aiming at testing all the language abilities. It includes several tests tapping into the different linguistic abilities, but for the purpose of the present study only the verb and object naming subtest will be administered. Higher scores indicate greater naming abilities
post treatment, 1 month
EuroQol Health-related quality of life (EQ-5D-3L)
Time Frame: post treatment, 1 month
The test consists of 2 sections. The first one is made of 5 questions scored from 1 to 5 points each. The final score ranges from 5 to 15, where the lesser the better. The second section is a visual scale on which the best state the patient can imagine is marked 100 and the worst state is marked 0.
post treatment, 1 month
Functional Outcome Questionnaire (FOQ-A)
Time Frame: post treatment, 1 month
The survey is administered to the caregiver. It includes 32 questions each scored from 1 to 5 points. The final scores ranges from 32 to 160, where higher scores indicate greater communication abilities
post treatment, 1 month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catholic University of the Sacred Heart

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondazione Poliambulanza

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Repetto, Prof, Catholic University of the Sacred Heart

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UC

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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