Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
patients in need of prosthetic interventions for Augmentative Alternative Communication, computer accessibility, and environmental control
patients who agree to participate in the study
Disqualifiers
none
Trial population
patients with mobility, communication or cognitive disability
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
scales and questionnaire administration
Other interventionevaluation of the quality of prosthetic intervention, verification of the adequacy of assistive devices, and outcomes measurement
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Fifty patients in need of ICT prosthetic interventions1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
T1 (6 months)2
IPPA-Individual Prioritised Problems Assessment
Perceived effectiveness of prescribed AT
Time frame
T0, T1 (3-6 months)3
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.
Time frame
T0, T1 (3-6 months)Secondary outcomes
1
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.
Time frame
T0, T1 (3-6 months)2
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.
Time frame
T0, T1 (3-6 months)3
ICF (International Classification of Functioning) core-sets
Classification of functioning, disability and health
Time frame
T0, T1 (3-6 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Ministry of Health, Italy
Collaborator
Source ClinicalTrials.gov