Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546813
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Outcomes of ICT Assistive Technology in RehabiliTAtIoN Pathways
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATTAIN
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 SMaria 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 99992016 and the Ministry of Health Prosthetics and Assistive Products List DPCM 12012017 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None