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Virtual Reality Training for Aphasia Rehabilitation (Aphasia360)

Primary Purpose

Anomic Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Video 360
Standard videos
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anomic Aphasia focused on measuring virtual reality, embodied cognition, rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PoliambulanzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video 360

Standard video

Arm 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").

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")

Outcomes

Primary Outcome Measures

Number of verbs and objects correctly named
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

Secondary Outcome Measures

Batteria per l'Analisi dei Deficit Afasici (BADA), naming subtest
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
EuroQol Health-related quality of life (EQ-5D-3L)
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.
Functional Outcome Questionnaire (FOQ-A)
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

Full Information

First Posted
March 7, 2023
Last Updated
March 20, 2023
Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione Poliambulanza
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1. Study Identification

Unique Protocol Identification Number
NCT05793879
Brief Title
Virtual Reality Training for Aphasia Rehabilitation
Acronym
Aphasia360
Official Title
Anomias Rehabilitation Training Through 360° Videos
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catholic University of the Sacred Heart
Collaborators
Fondazione Poliambulanza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anomic Aphasia
Keywords
virtual reality, embodied cognition, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video 360
Arm Type
Experimental
Arm 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").
Arm Title
Standard video
Arm Type
Active Comparator
Arm 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 Type
Behavioral
Intervention Name(s)
Video 360
Intervention Description
Patients will undergo 12 sessions, 3 per weeks, 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Standard videos
Intervention Description
Patients will undergo 12 sessions, 3 per weeks, 4 weeks
Primary Outcome Measure Information:
Title
Number of verbs and objects correctly named
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
Time Frame
post treatment, 1 month
Secondary Outcome Measure Information:
Title
Batteria per l'Analisi dei Deficit Afasici (BADA), naming subtest
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
Time Frame
post treatment, 1 month
Title
EuroQol Health-related quality of life (EQ-5D-3L)
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.
Time Frame
post treatment, 1 month
Title
Functional Outcome Questionnaire (FOQ-A)
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
Time Frame
post treatment, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Repetto, Prof
Phone
+39 3488122121
Email
claudia.repetto@unicatt.it
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Cancer, PhD
Email
alice.cancer@unicatt.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Repetto, Prof
Organizational Affiliation
Catholic University of the Sacred Heart
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliambulanza
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Maietti, Msc

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality Training for Aphasia Rehabilitation

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