Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways

NCT06546813 | Recruiting DMC

• 1 other identifier: ATTAIN
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Communication Aids for Disabled; Communication Disorders; Motor Disorders; Cognitive Disorder

Keywords

ICT AT; AAC AT; AAL AT; Assistive Technology; Outcome Assessment

Outcome Measures

Primary Outcomes (3)

• 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: 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.

  T1 (6 months)

• IPPA-Individual Prioritised Problems Assessment

  Perceived effectiveness of prescribed AT

  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.

  T0, T1 (3-6 months)

Secondary Outcomes (3)

• Barthel Index (BI) 20

  T0, T1 (3-6 months)

• CIRS-Modified Cumulative Illness Rating Scale (CIRS-CIRS)

  T0, T1 (3-6 months)

• ICF (International Classification of Functioning) core-sets

  T0, T1 (3-6 months)

Study Arms (1)

Fifty patients in need of ICT prosthetic interventions

Persons with communication, mobility or cognitive disability

Other: scales and questionnaire administration

Interventions

scales and questionnaire administration OTHER

evaluation of the quality of prosthetic intervention, verification of the adequacy of assistive devices, and outcomes measurement

Fifty patients in need of ICT prosthetic interventions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with mobility, communication or cognitive disability

You may qualify if:

• patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
• patients who agree to participate in the study

You may not qualify if:

• none

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi ONLUS

Milan, MI, 20148, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 37782310 BACKGROUND

• Salatino 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.

  PMID: 26479206 BACKGROUND

• Caronni 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.

  PMID: 36673791 BACKGROUND

MeSH Terms

Conditions

Communication Disorders; Motor Disorders; Cognitive Dysfunction

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Claudia Salatino

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Salatino

CONTACT

+39-0240308283; csalatino@dongnocchi.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Eng.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: August 9, 2024
• Study Start: June 1, 2023
• Primary Completion: September 30, 2025
• Study Completion: October 31, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)