NCT05793879

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

May 2, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 19, 2026

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

March 7, 2023

Last Update Submit

March 17, 2026

Conditions

Keywords

virtual realityembodied cognitionrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

    post treatment, 1 month

Secondary Outcomes (3)

  • Batteria per l'Analisi dei Deficit Afasici (BADA), naming subtest

    post treatment, 1 month

  • EuroQol Health-related quality of life (EQ-5D-3L)

    post treatment, 1 month

  • Functional Outcome Questionnaire (FOQ-A)

    post treatment, 1 month

Study Arms (2)

Video 360

EXPERIMENTAL

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

Standard video

ACTIVE COMPARATOR

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

Interventions

Video 360BEHAVIORAL

Patients will undergo 12 sessions, 3 per weeks, 4 weeks

Video 360
Standard videosBEHAVIORAL

Patients will undergo 12 sessions, 3 per weeks, 4 weeks

Standard video

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poliambulanza

Brescia, Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Anomia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia Repetto, Prof

    Catholic University of the Sacred Heart

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 7, 2023

First Posted

March 31, 2023

Study Start

May 2, 2023

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

March 19, 2026

Record last verified: 2025-09

Locations