Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07518576

Development and Validation of Language and Communication Assessment Scales

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Camillo

Venice, VE, 30126, Italy

Location status: Recruiting

Location contact

Sara Nordio

CONTACT

[email protected]

sara nrdio

PRINCIPAL_INVESTIGATOR

About this study

The goal of speech therapy for individuals with aphasia is to improve their communication effectiveness, enabling them to communicate in daily life. Traditional aphasia assessments focus on linguistic processes (e.g., naming, comprehension, dictation), which are categorized under impairment in the ICF framework, while everyday communication skills fall under activity and participation. However, there is a lack of consensus and appropriate tools for assessing everyday communication in aphasic patients, which are crucial for setting personalized treatment goals. The study suggests an interactive, multimodal model of language assessment, emphasizing the role of gestures in communication. It calls for the development of scales and tests that assess communication in a broader context, including factors like motivation, attention, awareness, and alternative communication strategies, as well as questionnaires evaluating both the individual's and caregiver's perceptions of communicative effectiveness and daily life participation. Moreover, an assessment tool of communicative gestures is needed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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

Treatment and study plan

conversational approach

Behavioral

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.

Primary outcomes

  1. Communicative efficacy

    Time frame: 36 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Nordio, SLP,PhD

CONTACT

[email protected]

3494990310

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Acronym: SCALE_COM

Important dates

Study start
2022
Primary completion
2022
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.