## Protocol Section
### Identification Module
**NCT ID:** NCT05793879

**Acronym:** Aphasia360

**Brief Title:** Virtual Reality Training for Aphasia Rehabilitation

**Official Title:** Anomias Rehabilitation Training Through 360° Videos

#### Organization Study ID Info
**ID:** UC
#### Organization
**Class:** OTHER
**Full Name:** Catholic University of the Sacred Heart
### Status Module
#### Completion Date
**Date:** 2026-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-05-02

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2023-03-31
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-07
**Study First Submit QC Date:** 2023-03-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Fondazione Poliambulanza

#### Lead Sponsor

**Class:** OTHER

**Name:** Catholic University of the Sacred Heart

#### Responsible Party

**Investigator Affiliation:** Catholic University of the Sacred Heart

**Investigator Full Name:** Claudia Repetto

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Anomic Aphasia

**Keywords:**

- virtual reality

- embodied cognition

- rehabilitation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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").

**Intervention Names:**

- Behavioral: Video 360

**Label:** Video 360

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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")

**Intervention Names:**

- Behavioral: Standard videos

**Label:** Standard video

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Video 360

**Description:** Patients will undergo 12 sessions, 3 per weeks, 4 weeks

**Name:** Video 360

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Standard video

**Description:** Patients will undergo 12 sessions, 3 per weeks, 4 weeks

**Name:** Standard videos

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Number of verbs and objects correctly named

**Time Frame:** post treatment, 1 month

#### Secondary Outcomes

**Description:** 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

**Measure:** Batteria per l'Analisi dei Deficit Afasici (BADA), naming subtest

**Time Frame:** post treatment, 1 month

**Description:** 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.

**Measure:** EuroQol Health-related quality of life (EQ-5D-3L)

**Time Frame:** post treatment, 1 month

**Description:** 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

**Measure:** Functional Outcome Questionnaire (FOQ-A)

**Time Frame:** post treatment, 1 month

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** claudia.repetto@unicatt.it

**Name:** Claudia Repetto, Prof

**Phone:** +39 3488122121

**Role:** CONTACT

**Contact 2:**

**Email:** alice.cancer@unicatt.it

**Name:** Alice Cancer, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Brescia

**Contacts:**

***Contact 1:***

- **Name:** Alessandra Maietti, Msc

- **Role:** CONTACT

**Country:** Italy

**Facility:** Poliambulanza

**Status:** RECRUITING

**Zip:** 25123

#### Overall Officials

**Official 1:**

**Affiliation:** Catholic University of the Sacred Heart

**Name:** Claudia Repetto, Prof

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000013064

- Term: Speech Disorders

- ID: D000007806

- Term: Language Disorders

- ID: D000003147

- Term: Communication Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M4352

- Name: Aphasia

- Relevance: HIGH

- As Found: Aphasia

- ID: M4175

- Name: Anomia

- Relevance: HIGH

- As Found: Anomic Aphasia

- ID: M15864

- Name: Speech Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10823

- Name: Language Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6374

- Name: Communication Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001037

- Term: Aphasia

- ID: D000000849

- Term: Anomia

### Misc Info Module

- Version Holder: 2024-05-24
