Ignite Creation Date:
2024-07-17 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489145
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-25
Brief Title:
Multi-domain Improvements in High-TEchnology Rehabilitation Programs for Post-stroke Patients
Sponsor:
University of Milano Bicocca
Organization:
University of Milano Bicocca
Study Overview
Official Title:
Users Experience and Cognitive Improvement in High-technology Rehabilitation Programs for Post-stroke Patients A Multi-method Multi-informant Patient-centred Approach
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITER
Brief Summary:
Through a multi-method multi-informant and patient-centred approach the study aims to investigate the experience of use and the effectiveness of rehabilitation technology robotics and virtual reality - VR in post-stroke patients and their caregivers and therapists
Detailed Description:
The present research will consist of two parallel studies
Study 1 ID 002565424 As a first goal the study aims to investigate pre- post-intervention changes on patients motor functional cognitive psychological and quality of life outcomes Intervention effects will be estimated among patients participating in technology-enhanced rehabilitation programs and compared to those undergoing traditional treatment only
As a second goal the study aims to evaluate patients subjective rehabilitation experience treatment expectations and compliance and in case of technology use devices usability acceptability and psychosocial impact
As a third goal the study aims to extend the evaluation on rehabilitation experience to patients caregivers specifically investigating their treatment expectations and at the end of the intervention treatment satisfaction
As a fourth goal the study aims to evaluate the rehabilitation experience and technology experience of use in patients therapists specifically investigating their treatment expectations and at the end of the intervention patients compliance and participation levels in the treatment
Study 2 ID RM-2024-803 Therapists will be also involved in a parallel qualitative investigation through focus-groups to further explore the barriers and facilitators related to the implementation of technological devices into post-stroke rehabilitation programs
Study 1 ID 002565424 As a first goal the study aims to investigate pre- post-intervention changes on patients motor functional cognitive psychological and quality of life outcomes Intervention effects will be estimated among patients participating in technology-enhanced rehabilitation programs and compared to those undergoing traditional treatment only
As a second goal the study aims to evaluate patients subjective rehabilitation experience treatment expectations and compliance and in case of technology use devices usability acceptability and psychosocial impact
As a third goal the study aims to extend the evaluation on rehabilitation experience to patients caregivers specifically investigating their treatment expectations and at the end of the intervention treatment satisfaction
As a fourth goal the study aims to evaluate the rehabilitation experience and technology experience of use in patients therapists specifically investigating their treatment expectations and at the end of the intervention patients compliance and participation levels in the treatment
Study 2 ID RM-2024-803 Therapists will be also involved in a parallel qualitative investigation through focus-groups to further explore the barriers and facilitators related to the implementation of technological devices into post-stroke rehabilitation programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RM-2024-803 | OTHER | None | None |