NCT07518576

Brief Summary

The aim of speech therapy for people with aphasia is to improve their ability to communicate in daily life. Traditional evaluations focus on linguistic tasks, but they do not fully address everyday communication skills, which are crucial for creating personalized treatment goals. The study suggests a multimodal approach to language assessment, stressing the importance of gestures in communication. It calls for the development of tools that evaluate communication in a wider context, including factors like motivation, attention, awareness, and alternative communication strategies. Additionally, there is a need for tools specifically designed to assess communicative gestures.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
7mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress88%
May 2022Dec 2026

Study Start

First participant enrolled

May 9, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

21 days

First QC Date

March 25, 2026

Last Update Submit

April 2, 2026

Conditions

Keywords

language disordersaphasiaconversationgesturesassessment

Outcome Measures

Primary Outcomes (1)

  • Communicative efficacy

    Validity of the Communicative Efficacy Scale - Italian version: Content and construct validity assessed in aphasic patients; construct validity via correlation with established communication and gesture measures (correlation coefficients -1 to +1; closer to ±1 = stronger relationship). Reliability of the Communicative Efficacy Scale - Italian version: Inter- and intra-rater reliability evaluated using Intraclass Correlation Coefficient Communicative efficacy refers to the ability to effectively convey thoughts, needs, and emotions in a way that others can understand. It involves clarity, adaptability in communication methods, effective interaction, and achieving communicative goals. In speech-language rehabilitation, enhancing communicative efficacy focuses on improving a person's ability to participate in social, personal, and professional interactions despite language impairments, aiming to increase confidence and meaningful engagement in everyday communication.

    36 months

Study Arms (1)

person with aphasia

Behavioral: conversational approach

Interventions

The conversational approach in speech-language rehabilitation focuses on improving communication within real-life, functional contexts. It emphasizes natural, interactive communication, helping individuals engage in meaningful conversations and participate in daily activities. Therapy often involves practicing communication in real-life scenarios, incorporating verbal and non-verbal cues. The goal is to enhance confidence and effectiveness in communication, allowing individuals with speech or language difficulties to regain autonomy and engage more fully in social and professional settings. Additionally, the assessment process is based on these principles and should also take place in conversation, evaluating communication skills within realistic, everyday contexts to better guide treatment planning.

person with aphasia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

person with aphasia

You may qualify if:

  • Patient admitted to the hospital for an intensive neurorehabilitation cycle or attending as an outpatient Diagnosis of language and communication disorders following a stroke in the right or left hemisphere Age \> 18 years Ability to provide informed consent Native speaker of Italian (L1 Italian)

You may not qualify if:

  • Unstable clinical conditions that may interfere with participation in the study (e.g., active symptomatic infections, stupor, need for oxygen therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Camillo

Venice, VE, 30126, Italy

RECRUITING

MeSH Terms

Conditions

Language DisordersAphasiaGestures

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeech DisordersKinesicsNonverbal CommunicationCommunicationBehavior

Central Study Contacts

Sara Nordio, SLP,PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 25, 2026

First Posted

April 8, 2026

Study Start

May 9, 2022

Primary Completion

May 30, 2022

Study Completion (Estimated)

December 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations