Generalized Mental, Social and/or Motor DisabilityNCT07066202
Impact Assessment of SALSA (Sensing and Automation for Freedom, Security, Autonomy) Technological Solutions
An observational study of Generalized Mental, Social and/or Motor Disability, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
This study evaluates the impact of assistive technologies designed to improve the independence and safety of adults with disabilities living in shared residential environments. The project is called SALSA, which stands for "Sensorisation, Automation for Freedom, Security and Autonomy." It is being conducted in Milan… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Mental, Social and/or Motor Disability
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2025to 31 Oct 2025
- 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 years and older
- All sexes
- Adult, Older adult
Study population: The impact assessment study will involve Cascina Biblioteca residents with the following characteristics: age over 18 and mental, social and/or motor disability.
Who may be able to join
- older than 18 years of age;
- mental, social and/or motor disability;
- signature of consent for participation.
Who cannot join
- under 18 years of age;
- non-signature of consent to participation.
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
Cascina Biblioteca Società Cooperativa Sociale
Milan, Italy
Marianna Guzzetti, +39, marianna.guzzetti@cascinabiblioteca.it
About this study
This study evaluates the impact of assistive technologies designed to improve the independence and safety of adults with disabilities living in shared residential environments. The project is called SALSA, which stands for "Sensorisation, Automation for Freedom, Security and Autonomy." It is being conducted in Milan, Italy, by a collaboration between Cascina Biblioteca Società Cooperativa Sociale, Fondazione Don Carlo Gnocchi ONLUS, and Informatici Senza Frontiere APS.
The goal of the study is to determine how well specific technologies-such as smart lighting systems and wearable monitoring devices-support residents' autonomy and daily functioning, while also reducing the workload for professional caregivers. These technologies are installed in apartments where people with mental, social, and/or physical disabilities live together with some support.
Read more
A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.
The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.
A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.
The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.
This research aims to provide practical insights into how technology can support adults with disabilities in more independent, safer living situations. It may also inform broader applications of these systems in similar care contexts. The protocol was approved by an Ethics Committee (CET 130/24; FDG 28_17/12/2024) and is in the data collection phase as of early 2025.
- Being tested
- No intervention is planned in this study. Only the assessment of a specific condition.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned in this study. Only the assessment of a specific condition.Other
No intervention is planned in this study. Only the assessment of a specific condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal Attainment Scale (GAS)
The Goal Attainment Scaling (GAS) is a scale used to measure how well individual therapy or intervention goals are achieved. It uses a 5-point scale ranging from -2 to +2, where each score reflects the degree to which the outcome met, exceeded, or fell short of expectations: +2: Outcome was much better than expected; +1: Outcome was somewhat better than expected; 0: Outcome was exactly as expected; -1: Outcome was somewhat below expectations; -2: Outcome was much worse than expected, possibly even below the starting point.
This structured approach allows for personalized goal tracking and provides a standardized way to evaluate progress in a meaningful and quantifiable manner.
Measured: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
Secondary outcomes (2)
Quantitative metrics
In addition to the Goal Attainment Scaling (GAS), the study will collect a range of quantitative metrics to better understand the impact of innovative technological solutions on the daily lives of individuals with disabilities. These metrics will include environmental conditions (e.g., indoor temperature), safety-related indicators (e.g., number of emergency situations, unintended door openings, lack of ventilation), and the frequency of critical events (e.g., falls, water leaks). This data will provide objective context to complement the subjective assessment of goal achievement, allowing for a more comprehensive evaluation of the interventions' effectiveness and their influence on everyday living conditions.
Measured: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
System Usability Scale (SUS)
The System Usability Scale (SUS) is a widely used tool for assessing user experience, specifically focusing on usability. It yields a score ranging from 0 to 100, where higher scores indicate a more favorable perception of usability. A SUS score above 68 is generally considered above average.
How the SUS Score is Calculated:
Collect Responses:
Participants answer 10 items using a 5-point Likert scale (from 1 = strongly disagree to 5 = strongly agree).
Score Odd-Numbered Items (1, 3, 5, 7, 9): subtract 1 from the participant's response.
Score Even-Numbered Items (2, 4, 6, 8, 10): subtract the participant's response from 5.
Sum the Adjusted Scores: add all the adjusted values together. Multiply by 2.5: the total is multiplied by 2.5 to obtain the final SUS score (ranging from 0 to 100).
SUS Score Interpretation Guide: 0-50: Poor (Awful); 51-67: Below Average (Poor); 68-71: Marginal (Okay); 72-80: Good; 80 and above: Excellent.
Measured: Evaluations will be conducted at three time points: T1: 30 days after the baseline T2: 60 days after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start11 Mar 2025
- 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.
- Other trials for Generalized Mental, Social and/or Motor DisabilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Cascina Biblioteca Società Cooperativa Sociale, Informatici Senza Frontiere APS
- Responsible party
- Principal investigator, Claudia Salatino, Fondazione Don Carlo Gnocchi ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066202
- Sponsor's protocol ID
- CET 130/24, FDG 28_17/12/2024
- Status last verified
- Aug 2025
- First submitted
- 17 Feb 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Impact Assessment of SALSA (Sensing and Automation for Freedom, Security, Autonomy) Technological Solutions
- ClinicalTrials.gov ID
- NCT07066202
- Acronym / sponsor ID
- CET 130/24, FDG 28_17/12/2024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Cascina Biblioteca Società Cooperativa Sociale, Informatici Senza Frontiere APS
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Jul 2025 (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.
This study evaluates the impact of assistive technologies designed to improve the independence and safety of adults with disabilities living in shared residential environments. The project is called SALSA, which stands for "Sensorisation, Automation for Freedom, Security and Autonomy." It is being conducted in Milan, Italy, by a collaboration between Cascina Biblioteca Società Cooperativa Sociale, Fondazione Don Carlo Gnocchi ONLUS, and Informatici Senza Frontiere APS.
The goal of the study is to determine how well specific technologies-such as smart lighting systems and wearable monitoring devices-support residents' autonomy and daily functioning, while also reducing the workload for professional caregivers. These technologies are installed in apartments where people with mental, social, and/or physical disabilities live together with some support.
A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.
The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.
A total of 55 adults over the age of 18, all residents of Cascina Biblioteca's shared flats, will be enrolled. Technologies will be set up prior to the beginning of the trial. Data will be collected in three phases: before using the technologies (T0), after 30 days (T1), and after 60 days (T2). The evaluation includes personalized goals, physical environment metrics (like temperature, air quality, door use, and night movements), and ease of use of the systems by staff.
The study uses Goal Attainment Scaling (GAS) to track whether residents achieve their individual or group goals, and the System Usability Scale (SUS) to assess how user-friendly the technologies are from the caregivers' perspective. All data will be collected through structured webforms to reduce the chance of missing information and increase consistency. The study team will use both descriptive and inferential statistical methods to assess results over time.
This research aims to provide practical insights into how technology can support adults with disabilities in more independent, safer living situations. It may also inform broader applications of these systems in similar care contexts. The protocol was approved by an Ethics Committee (CET 130/24; FDG 28_17/12/2024) and is in the data collection phase as of early 2025.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The impact assessment study will involve Cascina Biblioteca residents with the following characteristics: age over 18 and mental, social and/or motor disability.
Key inclusion criteria (3 listed)
- older than 18 years of age;
- mental, social and/or motor disability;
- signature of consent for participation.
Key exclusion criteria (2 listed)
- under 18 years of age;
- non-signature of consent to participation.
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 |
|---|---|---|
| No intervention is planned in this study. Only the assessment of a specific condition.No intervention is planned in this study. Only the assessment of a specific condition. | Other | – |
Primary outcome
Goal Attainment Scale (GAS)
Time frame: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
The Goal Attainment Scaling (GAS) is a scale used to measure how well individual therapy or intervention goals are achieved. It uses a 5-point scale ranging from -2 to +2, where each score reflects the degree to which the outcome met, exceeded, or fell short of expectations: +2: Outcome was much better than expected; +1: Outcome was somewhat better than expected; 0: Outcome was exactly as expected; -1: Outcome was somewhat below expectations; -2: Outcome was much worse than expected, possibly even below the starting point. This structured approach allows for personalized goal tracking and provides a standardized way to evaluate progress in a meaningful and quantifiable manner.
2 secondary outcomes
Quantitative metrics
Time frame: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline
System Usability Scale (SUS)
Time frame: Evaluations will be conducted at three time points: T1: 30 days after the baseline T2: 60 days after the baseline
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.
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 Generalized Mental, Social and/or Motor Disability, 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 3 inclusion and 2 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Goal Attainment Scale (GAS) (time frame: Evaluations will be conducted at three time points: T0: Baseline (initial assessment) T1: 30 days after the baseline T2: 60 days after the baseline). 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 26 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.