ClinicalTrials.gg
RecruitingNCT07518576SCALE_COMUpdated Apr 8, 2026

Development and Validation of Language and Communication Assessment Scales

An observational study in Language Disorders and Aphasia, sponsored by IRCCS San Camillo, Venezia, Italy. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-08.

Primary conditionAphasiaRegistry: Language DisordersReclassifiedWhy we changed it
Registry
Language Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Aphasia
Why
  1. The study's listed conditions name Aphasia, a narrower term within Language Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by IRCCS San Camillo, Venezia, Italy · Observational

From the registry’s dates

  • Started May 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Language Disorders
  • Aphasia

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Keywords

  • language disorders
  • aphasia
  • conversation
  • gestures
  • assessment
03

In context

Aphasia Reclassified

338 studies on the registry are indexed under Aphasia; 95 are open to participants now.

This study's planned enrollment of 50 is below the median of 77 across 36 observational studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

IRCCS San Camillo, Venezia, Italy is the lead sponsor of 48 studies on the registry; 18 are open to participants now.

Compared within Aphasia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Language Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

person with aphasia

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 Native speaker of Italian (L1 Italian)

Exclusion criteria

Exclusion Criteria:

  • Unstable clinical conditions that may interfere with participation in the study (e.g., active symptomatic infections, stupor, need for oxygen therapy)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • person with aphasia

    Behavioral: conversational approach

Interventions

  • Behavioralconversational 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.

06

What researchers measure

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.

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518576
Lead sponsor
IRCCS San Camillo, Venezia, Italy
Responsible party
Sara Nordio (PhD, IRCCS San Camillo, Venezia, Italy) — Principal investigator
First posted
Apr 8, 2026
Start date
May 9, 2022
Primary completion
May 30, 2022
Completion
Dec 31, 2026 (estimated)
Last update
Apr 8, 2026

Study contacts

Sara Nordio, SLP,PhD
Contact
sara.nordio@hsancamillo.it
3494990310

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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