- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05793879
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
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- 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 Locations
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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").
|
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")
|
Patients will undergo 12 sessions, 3 per weeks, 4 weeks
|
What is the study measuring?
Primary Outcome Measures
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
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.
Collaborators
Investigators
- 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)
May 2, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
March 7, 2023
First Submitted That Met QC Criteria
March 20, 2023
First Posted (Actual)
March 31, 2023
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 17, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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
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