Communication Aids for DisabledATTAINNCT06546813
Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
An observational study of Communication Aids for Disabled and Communication Disorders, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The study aims to improve the quality of prosthetic intervention and verify the adequacy of assistive devices, and measurement outcomes. Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control will be recruited within the DAT Unit… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Communication Aids for Disabled, Communication Disorders, Motor Disorders
- What is being tested?
- scales and questionnaire administration
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 31 Oct 2025
- How long will I take part?
- 6 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with mobility, communication or cognitive disability
Who may be able to join
- patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
- patients who agree to participate in the study
Who cannot join
- none
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 Fondazione Don Carlo Gnocchi ONLUS
Milan, MI, 20148
Claudia Salatino, +39-02-40308283, csalatino@dongnocchi.it
About this study
The study aims to improve the quality of prosthetic intervention and verify the adequacy of assistive devices, and measurement outcomes. Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi "IRCCS S.Maria Nascente" in Milan. At baseline (T0) a physician and a psychologist will perform a clinical evaluation and the AT outcome assessment. The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will readminister the AT outcome assessment. In order to make the assessment accessible to all participants, these tests and questionnaires will be administered on Windows PCs, using Grid3 software, or on a specifically created accessible web page.
Read the detailed description
Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication (AAC), computer accessibility, and environmental control (for example, communicators, facilitated keyboards, mouse emulators, eye pointers, accessibility software, and remote controls for home control) will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi ONLUS "IRCCS Santa Maria Nascente" in Milan. At baseline (T0) a physician will administer the Barthel Index 20 the Modified Cumulative Illness Rating Scale (CIRS), the ICF Generic Core Set-7, the ICF-core set for profiling communicative competence for AAC AT assessments or the ICF-Vocational Rehabilitation Brief Core Set integrated with some items of the Comprehensive one for ICT AT. A psychologist will assess patients' cognitive status using the Oxford Cognitive Screening (OCS), the CPM-Coloured Progressive Matrices, the Palm and Pyramid Trees Test - short version, the Aachener Aphasie Test (AAT) subtest on written and oral comprehension of words and sentences, the Multiple Features Targets Cancellation (MFTC). In order to make the cognitive assessment accessible to all participants, these tests will be administered on Windows PCs, using The Grid3 software, or on a specifically created accessible web page. According to the clinical and cognitive assessment, the health practitioner will decide whether to administer the assessment protocol to the patient or to the closest relative. The AT assessment protocol includes at baseline: the EQ-5D-5L questionnaire for quality of life and the Individual Prioritised Problems Assessment (IPPA) to assess the importance and severity of the problems the participants expect to improve with the AT use. The DAT multidisciplinary team will conduct the AT assessment and the most appropriate assistive solution will be identified and prescribed or suggested. The assistive devices received will be classified according to the international standard ISO 9999:2016 and the Ministry of Health Prosthetics and Assistive Products List (DPCM 12/01/2017). The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will administer the IPPA questionnaire, the ICF Core Sets, the EQ-5D-5L questionnaire, and the Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire (QUEST). Quantitative data will be summarized by appropriate descriptive statistics (mean, standard deviation, median, and ranges). Qualitative data will be summarized in contingency tables.
- Conditions
- Communication Aids for Disabled, Communication Disorders, Motor Disorders, Cognitive Disorder
- Being tested
- scales and questionnaire administration
- Keywords
- ICT AT, AAC AT, AAL AT, Assistive Technology, Outcome Assessment
- Medical subject headings
- Communication Disorders, Motor Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scales and questionnaire administrationOther
evaluation of the quality of prosthetic intervention, verification of the adequacy of assistive devices, and outcomes measurement
| Study group | Role | What they receive |
|---|---|---|
| Fifty patients in need of ICT prosthetic interventions | Persons with communication, mobility or cognitive disability Receives: Other: scales and questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire
The "Questionnaire de Satisfaction des Usagers des Services en Travailleur Autonome" (QUEST) evaluates user satisfaction with home care and assistive technology services. It assesses:
- Overall Satisfaction: How well the service met expectations.
- Quality of Services: Perception of service quality, including provider competence and professionalism.
- Effectiveness: Impact on quality of life and independence.
- Accessibility: Ease of accessing services, considering geography, waiting times, and cost.
- Adequacy: How well the service met individual needs and preferences.
- Support and Training: Quality of support and training for using the service or technology.
Users answer specific questions on a rating scale, helping to identify areas for improvement and optimize service quality.
Measured: T1 (6 months)
IPPA-Individual Prioritised Problems Assessment
Perceived effectiveness of prescribed AT
Measured: T0, T1 (3-6 months)
EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
The EQ-5D-5L(EuroQol - 5 Dimensions - 5 Levels) measures health-related quality of life across five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each dimension has five severity levels ranging from "No problems" to "Extreme problems." Respondents choose a level for each dimension, resulting in a health profile of five numbers. Additionally, the scale includes a Visual Analog Scale (VAS) where overall health is rated from 0 (worst imaginable) to 100 (best imaginable). The profile can be converted into a single utility score, ranging from about -0.281 (worse than death) to 1 (perfect health). Higher scores indicate better health outcomes.
Measured: T0, T1 (3-6 months)
Secondary outcomes (3)
Barthel Index (BI) 20
The Barthel Index (BI) - 20-point version assesses basic daily living activities to measure a patient's independence. It scores 10 activities (e.g., feeding, bathing, dressing) from 0 to 2 points each, where 0 is total dependence, 1 is partial assistance needed, and 2 is complete independence. Scores are summed to determine the level of dependence: 0-4 (total dependence), 5-9 (severe), 10-14 (moderate), 15-19 (slight), and 20 (complete independence). The index is used by healthcare professionals or caregivers through a structured questionnaire or checklist to evaluate disability, plan discharge, and monitor rehabilitation progress.
Measured: T0, T1 (3-6 months)
CIRS-Modified Cumulative Illness Rating Scale (CIRS-CIRS)
Health condition:
A low total score indicates good overall health with few or no significant chronic problems.
A high total score indicates numerous severe chronic conditions, suggesting a high degree of comorbidity and a need for intensive medical intervention.
Measured: T0, T1 (3-6 months)
ICF (International Classification of Functioning) core-sets
Classification of functioning, disability and health
Measured: T0, T1 (3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jun 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Communication Aids for DisabledStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Claudia Salatino, Fondazione Don Carlo Gnocchi ETS
- Investigators
- Claudia Salatino, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546813
- Sponsor's protocol ID
- ATTAIN
- Acronym
- ATTAIN
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borgnis F, Desideri L, Converti RM, Salatino C. Available Assistive Technology Outcome Measures: Systematic Review. JMIR Rehabil Assist Technol. 2023 Nov 15;10:e51124. doi: 10.2196/51124.
PubMed 37782310Salatino C, Andrich R, Converti RM, Saruggia M. An observational study of powered wheelchair provision in Italy. Assist Technol. 2016 Spring;28(1):41-52. doi: 10.1080/10400435.2015.1074631.
PubMed 26479206Caronni A, Ramella M, Arcuri P, Salatino C, Pigini L, Saruggia M, Folini C, Scarano S, Converti RM. The Rasch Analysis Shows Poor Construct Validity and Low Reliability of the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) Questionnaire. Int J Environ Res Public Health. 2023 Jan 6;20(2):1036. doi: 10.3390/ijerph20021036.
PubMed 36673791
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
- ClinicalTrials.gov ID
- NCT06546813
- Acronym / sponsor ID
- ATTAIN / ATTAIN
- Conditions
- Communication Aids for Disabled, Communication Disorders, Motor Disorders, Cognitive Disorder
- Keywords
- ICT AT, AAC AT, AAL AT, Assistive Technology, Outcome Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Aug 2024 (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 study aims to improve the quality of prosthetic intervention and verify the adequacy of assistive devices, and measurement outcomes. Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi "IRCCS S.Maria Nascente" in Milan. At baseline (T0) a physician and a psychologist will perform a clinical evaluation and the AT outcome assessment. The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will readminister the AT outcome assessment. In order to make the assessment accessible to all participants, these tests and questionnaires will be administered on Windows PCs, using Grid3 software, or on a specifically created accessible web page.
Detailed description
Fifty patients in need of prosthetic interventions for Augmentative Alternative Communication (AAC), computer accessibility, and environmental control (for example, communicators, facilitated keyboards, mouse emulators, eye pointers, accessibility software, and remote controls for home control) will be recruited within the DAT Unit of the Fondazione Don Carlo Gnocchi ONLUS "IRCCS Santa Maria Nascente" in Milan. At baseline (T0) a physician will administer the Barthel Index 20 the Modified Cumulative Illness Rating Scale (CIRS), the ICF Generic Core Set-7, the ICF-core set for profiling communicative competence for AAC AT assessments or the ICF-Vocational Rehabilitation Brief Core Set integrated with some items of the Comprehensive one for ICT AT. A psychologist will assess patients' cognitive status using the Oxford Cognitive Screening (OCS), the CPM-Coloured Progressive Matrices, the Palm and Pyramid Trees Test - short version, the Aachener Aphasie Test (AAT) subtest on written and oral comprehension of words and sentences, the Multiple Features Targets Cancellation (MFTC). In order to make the cognitive assessment accessible to all participants, these tests will be administered on Windows PCs, using The Grid3 software, or on a specifically created accessible web page. According to the clinical and cognitive assessment, the health practitioner will decide whether to administer the assessment protocol to the patient or to the closest relative. The AT assessment protocol includes at baseline: the EQ-5D-5L questionnaire for quality of life and the Individual Prioritised Problems Assessment (IPPA) to assess the importance and severity of the problems the participants expect to improve with the AT use. The DAT multidisciplinary team will conduct the AT assessment and the most appropriate assistive solution will be identified and prescribed or suggested. The assistive devices received will be classified according to the international standard ISO 9999:2016 and the Ministry of Health Prosthetics and Assistive Products List (DPCM 12/01/2017). The participants will be contacted for the follow-up phase (T1) 3 to 6 months after having received the assistive solution. At T1 clinicians will administer the IPPA questionnaire, the ICF Core Sets, the EQ-5D-5L questionnaire, and the Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire (QUEST). Quantitative data will be summarized by appropriate descriptive statistics (mean, standard deviation, median, and ranges). Qualitative data will be summarized in contingency tables.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fifty patients in need of ICT prosthetic interventions | – | Other: scales and questionnaire administrationPersons with communication, mobility or cognitive disability |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with mobility, communication or cognitive disability
Key inclusion criteria (2 listed)
- patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
- patients who agree to participate in the study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| scales and questionnaire administrationevaluation of the quality of prosthetic intervention, verification of the adequacy of assistive devices, and outcomes measurement | Other | Fifty patients in need of ICT prosthetic interventions |
Primary outcome
QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire
Time frame: T1 (6 months)
The "Questionnaire de Satisfaction des Usagers des Services en Travailleur Autonome" (QUEST) evaluates user satisfaction with home care and assistive technology services. It assesses: 1. Overall Satisfaction: How well the service met expectations. 2. Quality of Services: Perception of service quality, including provider competence and professionalism. 3. Effectiveness: Impact on quality of life and independence. 4. Accessibility: Ease of accessing services, considering geography, waiting times, and cost. 5. Adequacy: How well the service met individual needs and preferences. 6. Support and Training: Quality of support and training for using the service or technology. Users answer specific questions on a rating scale, helping to identify areas for improvement and optimize service quality.
IPPA-Individual Prioritised Problems Assessment
Time frame: T0, T1 (3-6 months)
Perceived effectiveness of prescribed AT
EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels)
Time frame: T0, T1 (3-6 months)
The EQ-5D-5L(EuroQol - 5 Dimensions - 5 Levels) measures health-related quality of life across five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression. Each dimension has five severity levels ranging from "No problems" to "Extreme problems." Respondents choose a level for each dimension, resulting in a health profile of five numbers. Additionally, the scale includes a Visual Analog Scale (VAS) where overall health is rated from 0 (worst imaginable) to 100 (best imaginable). The profile can be converted into a single utility score, ranging from about -0.281 (worse than death) to 1 (perfect health). Higher scores indicate better health outcomes.
3 secondary outcomes
Barthel Index (BI) 20
Time frame: T0, T1 (3-6 months)
CIRS-Modified Cumulative Illness Rating Scale (CIRS-CIRS)
Time frame: T0, T1 (3-6 months)
ICF (International Classification of Functioning) core-sets
Time frame: T0, T1 (3-6 months)
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 26 Aug 2025.
- Background: PubMed 37782310Borgnis F, Desideri L, Converti RM, Salatino C. Available Assistive Technology Outcome Measures: Systematic Review. JMIR Rehabil Assist Technol. 2023 Nov 15;10:e51124. doi: 10.2196/51124.
- Background: PubMed 26479206Salatino C, Andrich R, Converti RM, Saruggia M. An observational study of powered wheelchair provision in Italy. Assist Technol. 2016 Spring;28(1):41-52. doi: 10.1080/10400435.2015.1074631.
- Background: PubMed 36673791Caronni A, Ramella M, Arcuri P, Salatino C, Pigini L, Saruggia M, Folini C, Scarano S, Converti RM. The Rasch Analysis Shows Poor Construct Validity and Low Reliability of the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 (QUEST 2.0) Questionnaire. Int J Environ Res Public Health. 2023 Jan 6;20(2):1036. doi: 10.3390/ijerph20021036.
- 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.
Claudia Salatino principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
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 Communication Aids for Disabled and Communication Disorders, run by Fondazione Don Carlo Gnocchi ETS 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 2 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 26 Aug 2025. 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 Claudia Salatino (+39-0240308283, csalatino@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire (time frame: T1 (6 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546813, which also lists 3 linked publications.
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 26 Aug 2025.