Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT06449612
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2024-05-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke
Sponsor:
Corina Schuster-Amft
Organization:
Study Overview
Official Title:
Telerehabilitation After a Stroke: Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke in the Subacute Phase
Status:
COMPLETED
Status Verified Date:
2025-08
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:
TeleRehaStroke
Brief Summary:
The goal of this investigation is to evaluate the feasibility, safety and performance of an application-based training programme in patients after a stroke in the subacute phase.
* Is the training programme 'TeleRehaStroke' using the mobile application 'Blended Clinic' for patients after a stroke feasible and usable?
* How is the user experience of the mobile application-based training programme?
Participants will:
* Get to know the programme and use the application 'Blended Clinic' during their last weeks before discharge from the inpatient rehabilitation.
* Be guided through inpatient setting, transition and outpatient setting and be accompanied by a coaching therapist via the application.
* Continue to use the application for 12 weeks after discharge from rehabilitation.
* Is the training programme 'TeleRehaStroke' using the mobile application 'Blended Clinic' for patients after a stroke feasible and usable?
* How is the user experience of the mobile application-based training programme?
Participants will:
* Get to know the programme and use the application 'Blended Clinic' during their last weeks before discharge from the inpatient rehabilitation.
* Be guided through inpatient setting, transition and outpatient setting and be accompanied by a coaching therapist via the application.
* Continue to use the application for 12 weeks after discharge from rehabilitation.
Detailed Description:
It is challenging for patients after stroke to maintain motivation to continue and sustain training at home with the same intensity after an inpatient rehabilitation. An emerging approach is represented by digital applications that are easily and flexibly accessible from home. An existing virtual blended care environment 'Blended Clinic' (Blended Clinic AI GmbH) involves a mobile application that provides a training platform for patients after a stroke. The successor version 'TeleRehaStroke' builds on the previous version 'Strokecoach' that comprises three main modules: (1) training, (2) coaching, and (3) monitoring.
The aim of this evaluation is to assess feasibility, safety and performance of the 'TeleRehaStroke' programme for stroke patients in the transition phase from inpatient to outpatient rehabilitation.
Patients after a stroke will be recruited in the subacute phase. They will use the 'TeleRehaStroke' programme during their last weeks of their inpatient rehabilitation and for a further 12 weeks following their discharge to an outpatient setting. This includes daily exercises and blood pressure measurements. In addition, patients will receive coaching messages, educational content and questionnaires via the application. They will be accompanied by a coach via the app.
Feasibility outcomes, patient's descriptive, clinical- and performance-based parameters will be evaluated. Outcomes will be assessed at different time points.
The aim of this evaluation is to assess feasibility, safety and performance of the 'TeleRehaStroke' programme for stroke patients in the transition phase from inpatient to outpatient rehabilitation.
Patients after a stroke will be recruited in the subacute phase. They will use the 'TeleRehaStroke' programme during their last weeks of their inpatient rehabilitation and for a further 12 weeks following their discharge to an outpatient setting. This includes daily exercises and blood pressure measurements. In addition, patients will receive coaching messages, educational content and questionnaires via the application. They will be accompanied by a coach via the app.
Feasibility outcomes, patient's descriptive, clinical- and performance-based parameters will be evaluated. Outcomes will be assessed at different time points.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: