Development and Validation of Language and Communication Assessment Scales (SCALE_COM)

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.

Study Overview

• Status: Recruiting
• Conditions: Language Disorders; Aphasia
• Intervention / Treatment: Behavioral: conversational approach

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Sara Nordio, SLP,PhD; Phone Number: 3494990310; Email: sara.nordio@hsancamillo.it

Study Locations

• Italy
  • VE
    • Venice, VE, Italy, 30126
      • Recruiting
      • IRCCS San Camillo
      • Contact: Sara Nordio; Email: sara.nordio@hsancamillo.it
      • Principal Investigator: sara nrdio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

person with aphasia

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

person with aphasia

Behavioral: conversational approach; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: assessment; aphasia; language disorders; gestures; conversation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Communication; Nonverbal Communication; Kinesics; Aphasia; Language Disorders; Gestures
• Other Study ID Numbers: 2022.02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No