Language DisordersSCALE_COMNCT07518576
Development and Validation of Language and Communication Assessment Scales
An observational study of Language Disorders and Aphasia, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Language Disorders, Aphasia
- What is being tested?
- conversational approach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: person with aphasia
Who may be able to join
- 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)
Who cannot join
- Unstable clinical conditions that may interfere with participation in the study (e.g., active symptomatic infections, stupor, need for oxygen therapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Camillo
Venice, VE, 30126
Sara Nordio, sara.nordio@hsancamillo.it
sara nrdio
About this study
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.
- Conditions
- Language Disorders, Aphasia
- Being tested
- conversational approach
- Keywords
- language disorders, aphasia, conversation, gestures, assessment
- Medical subject headings
- Language Disorders, Aphasia, Gestures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conversational approachBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| person with aphasia | Not described Receives: Behavioral: conversational approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start9 May 2022
- Primary completion30 May 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Nordio, IRCCS San Camillo, Venezia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518576
- Sponsor's protocol ID
- 2022.02
- Acronym
- SCALE_COM
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Language and Communication Assessment Scales
- ClinicalTrials.gov ID
- NCT07518576
- Acronym / sponsor ID
- SCALE_COM / 2022.02
- Conditions
- Language Disorders, Aphasia
- Keywords
- language disorders, aphasia, conversation, gestures, assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| person with aphasia | – | Behavioral: conversational approach |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- person with aphasia
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Unstable clinical conditions that may interfere with participation in the study (e.g., active symptomatic infections, stupor, need for oxygen therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conversational approachThe 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. | Behavioural | person with aphasia |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Language Disorders and Aphasia, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Nordio, SLP,PhD (3494990310, sara.nordio@hsancamillo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communicative efficacy (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.