Clinical trial NCT06449612: Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Telerehabilitation
Stroke Rehabilitation
Exercise
Home-based Rehabilitation
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Feasibility process-related parameters: Recruitment rate
timeFrame: through total study completion (up to 12 months)
measure: Feasibility process-related parameters: Process evaluation
timeFrame: through total study completion (up to 12 months)
measure: Feasibility of training-related parameters: (Serious) adverse events and device deficiencies
timeFrame: through study completion, up to 4 months
measure: Feasibility of training-related parameters: Acceptance
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of training-related parameters: Adherence to exercise and monitoring
timeFrame: through study completion, up to 4 months
measure: Feasibility of training-related parameters: Drop-out Rate
timeFrame: through total study completion (up to 12 months)
measure: Feasibility of mHealth-related parameters: Stability and maintenance
timeFrame: through total study completion (up to 12 months)
measure: Feasibility of mHealth-related parameters: Usability measured with the System Usability Scale (SUS)
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of mHealth-related parameters: Usability measured with the German version of mHealth App Usability Questionnaire (G-MAUQ)
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of mHealth-related parameters: Quality
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of mHealth-related parameters: Satisfaction
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of mHealth-related parameters: User- and training experience:
timeFrame: end of intervention, approx. after 4 months
measure: Feasibility of mHealth-related parameters: Perceived change
timeFrame: end of intervention, approx. after 4 months
Secondary outcomes:
measure: Change in functional status as assessed by the Functional Independence Measure (FIM)
timeFrame: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
measure: Change in ambulation as assessed by the Functional Ambulation Categories (FAC)
timeFrame: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
measure: Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline
timeFrame: baseline
measure: Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline
timeFrame: baseline
measure: Change in disability level on the Modified Rankin Scale (mRS)
timeFrame: baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
measure: Change in self-reported disability on the Stroke Impact Scale (SIS)
timeFrame: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
measure: Change in health-related quality of life assessed by the 36-Item Short Form Healthy Survey (SF-36)
timeFrame: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
measure: Change in quality of life as assessed by the EuroQoL EQ-5D-3L
timeFrame: baseline, end of intervention (approx. 4 months)
measure: Life-space mobility as assessed by the German Life-Space Assessment (LSA-G)
timeFrame: discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
measure: Change in sitting balance as measured by the Trunk Impairment Scale (TIS)
timeFrame: baseline, end of intervention (approx. 4 months)
measure: Change in mobility assessed by the Timed Up and Go (TUG)
timeFrame: baseline, end of intervention (approx. 4 months)
measure: Blood pressure and heart rate
timeFrame: through study completion, up to 4 months
measure: Change in physical performance as assessed by the Short Physical Performance Battery (SPPB)
timeFrame: baseline, end of intervention (approx. 4 months)
measure: Physical activity - accelerometry
timeFrame: from start of the intervention to discharge (up to 3 weeks), and last 3 weeks before end of intervention (approx. after 3 months)
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: AG
Study officials:
References: