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Recruiting Observational

Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways

NCT06546813 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2023-06-01
Last updated
2025-08-26

Condition(s) studied

Communication Aids for DisabledCommunication DisordersMotor DisordersCognitive Disorder

Investigational drug(s) / intervention(s)

scales and questionnaire administration

scales and questionnaire administration: evaluation of the quality of prosthetic intervention, verification of the adequacy of assistive devices, and outcomes measurement

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
consecutive enrollment of subjects falling within Inclusion Criteria: * patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control * patients who agree to participate in the study Exclusion Criteria: * none

Primary outcome measure(s)

  • QUEST-Quebec User Evaluation of Satisfaction with Assistive Technology Questionnaire — 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 — T0, T1 (3-6 months)
    Perceived effectiveness of prescribed AT
  • EQ-5D-5L (EuroQol - 5 Dimensions - 5 Levels) — 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.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Fondazione Don Carlo Gnocchi ONLUS Milan MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06546813 on ClinicalTrials.gov ↗ ← All trials in Italy