Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke

NCT ID: NCT06449612

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-26
• Study Completion Date: 2025-07-29

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.

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

'TeleRehaStroke' Intervention Group

The 'TeleRehaStroke' programme is an application-based training programme for patients after a stroke, comprising three main modules: (1) training, (2) coaching, and (3) monitoring:

Training: Six-week training programmes have been created that focus on the lower extremity and balance. Via the application, patients are provided with a personalised training plan adapted to their individual impairments including exercise videos.

Coaching: Participants will be accompanied by a coaching therapist via messenger, which is included in the application.

Monitoring: Blood pressure measurements can be entered and saved in the application. Questionnaires can be sent to be filled in by the participants.

Group Type: EXPERIMENTAL

TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application

Intervention Type: DEVICE

Primary end users (patients after stroke) will be familiarised with the application and the 'TeleRehaStroke' programme in two to three sessions during their last two to three weeks prior to discharge from the inpatient rehabilitation centre. This includes performing daily exercises, wearing an activity tracker and measuring blood pressure daily. Following discharge from rehabilitation, they will continue to use the application for 12 weeks.

Interventions

TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application

Primary end users (patients after stroke) will be familiarised with the application and the 'TeleRehaStroke' programme in two to three sessions during their last two to three weeks prior to discharge from the inpatient rehabilitation centre. This includes performing daily exercises, wearing an activity tracker and measuring blood pressure daily. Following discharge from rehabilitation, they will continue to use the application for 12 weeks.

Intervention Type: DEVICE

Other Intervention Names

Blended Clinic, Blended Clinic AI, Nuremberg, Germany (https://blended.clinic/de/)

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• Clinically confirmed stroke
• Modified Rankin Scale score 1-5
• Able, to read and understand German language
• Owns a smartphone or a tablet with stable internet connection and the operating system Android version 11 or iOS version 14 or higher

Exclusion Criteria

• Severe Aphasia
• Clinically significant concomitant disease states: visual, neurological, cardiorespiratory, psychiatric, or orthopaedic limitations that prevent a participant from following the investigator's instructions or limit performance in an exercise programme
• Recent events such as surgery or other surgical procedures, fractures, which limit the performance in an exercise programme
• Known or suspected non-compliance, drug or alcohol abuse
• Participation in another investigation (with interventional therapy, investigational drug or another medical device) within the 30 days preceding and during the present investigation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corina Schuster-Amft

OTHER

Sponsor Role: lead

Responsible Party

Corina Schuster-Amft

Head of Research Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Countries

Switzerland

References

Gaumann S, Ziller C, Paulissen N, Behrendt F, Suica Z, Cruts B, Gammerschlag L, Parmar K, Gerth HU, Bonati LH, Schuster-Amft C. START-the Swiss tele-assisted rehabilitation and training program to support transition from inpatient to outpatient care in the subacute phase after a stroke: feasibility, safety and performance evaluation. Front Digit Health. 2025 Jan 31;6:1496170. doi: 10.3389/fdgth.2024.1496170. eCollection 2024.

Reference Type: DERIVED

PMID: 39959919 (View on PubMed)

Other Identifiers

TeleRehaStroke

Identifier Type: -

Identifier Source: org_study_id