StrokeTeleRehaStrokeNCT06449612
Feasibility, Safety and Performance Evaluation of an Application Based Training Programme for Patients After a Stroke
A study testing TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application in people with Stroke, run by Corina Schuster-Amft at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jul 2024to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read more
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.
Read the 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
- Being tested
- TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application
- Keywords
- Telerehabilitation, Stroke Rehabilitation, Exercise, Home-based Rehabilitation
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleRehaStroke: Training programme using the 'Blended Clinic' mobile applicationDevice
Also called Blended Clinic, Blended Clinic AI, Nuremberg, Germany (https://blended.clinic/de/)
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.
| Study group | Role | What they receive |
|---|---|---|
| 'TeleRehaStroke' Intervention Group | Experimental | 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. Receives: Device: TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility process-related parameters: Recruitment rate
The number of screened patients versus included patients. It will be considered feasible if ≥40% of informed patients will be enrolled and ≥75% of targeted sample size will be reached.
Measured: through total study completion (up to 12 months)
Feasibility process-related parameters: Process evaluation
The absolute duration of study-related duties of study personnel/coach in minutes during the inpatient and the outpatient period will be determined.
Measured: through total study completion (up to 12 months)
Feasibility of training-related parameters: (Serious) adverse events and device deficiencies
Number of adverse events (i.e., deaths, serious and non-serious adverse events as well as device deficiencies) will be reported for each patient. The criterion for success is the incidence of an adverse event in <10% of participants.
Measured: through study completion, up to 4 months
Feasibility of training-related parameters: Acceptance
Patient satisfaction will be measured with the Net Promoter Score (NPS). It involves a single question ('How likely is it that you would recommend TeleRehaStroke to a friend or colleague?' with an 11-point rating scale. It will be considered as successful if the average satisfaction is ≥50%.
Measured: end of intervention, approx. after 4 months
Feasibility of training-related parameters: Adherence to exercise and monitoring
Exercise adherence will be measured as the ratio of completed versus planned trainings. Monitoring adherence will be measured as the ratio of completed versus planned blood pressure measurements and activity tracker wearing time. Adherence ≥70% will be considered as successful.
Measured: through study completion, up to 4 months
Feasibility of training-related parameters: Drop-out Rate
It will be defined as successful if ≥80% of enrolled participants will complete the study.
Measured: through total study completion (up to 12 months)
Feasibility of mHealth-related parameters: Stability and maintenance
The number and description of system errors will be determined and defined as acceptable if ≤3 system failures occur per week.
Measured: through total study completion (up to 12 months)
Feasibility of mHealth-related parameters: Usability measured with the System Usability Scale (SUS)
The SUS consists of 10 statements considering the system evaluated on a five-point rating scale from strongly agree to strongly disagree. Scores above 70 represent an acceptable usability, with scores smaller than 50 being judged as unacceptable.
Measured: end of intervention, approx. after 4 months
Feasibility of mHealth-related parameters: Usability measured with the German version of mHealth App Usability Questionnaire (G-MAUQ)
The G-MAUQ consists of 18 items distributed across three dimensions: ease of use, interface and satisfaction and usefulness. Using a 7-point rating scale, from 1 (strongly agree) to 7 (strongly disagree), patients rate each item. An average scoring of ≥4 will count as successful.
Measured: end of intervention, approx. after 4 months
Feasibility of mHealth-related parameters: Quality
The user version of the Quality Assessment of Health related Apps (AQUA) consists of 31 items and assesses seven basic dimension of app-quality. All items use a five-point rating scale from 5 (strongly agree) to 1 (strongly disagree). By calculating the mean score for each dimension, the quality of an app with regard to each of the dimensions can be determined and compared. By calculating the overall mean a total score can be determined. Success is defined if the average scoring in each dimension is ≥3.
Measured: end of intervention, approx. after 4 months
Feasibility of mHealth-related parameters: Satisfaction
Patient's subjective satisfaction will be assessed using a visual analogue scale from not satisfied at all to extremely satisfied. ('How satisfied are you with the application?'). An average satisfaction of ≥50% is considered a success.
Measured: end of intervention, approx. after 4 months
Feasibility of mHealth-related parameters: User- and training experience:
A self-designed feedback questionnaire with a five-point rating scale (1: extremely negative to 5: extremely positive) including specific questions related to user experience, interaction with the devices, and coaching experience will be used.
Measured: end of intervention, approx. after 4 months
Feasibility of mHealth-related parameters: Perceived change
Patients' subjective global perceived change will be assessed using a visual analogue scale (VAS) from very much worse to very much improved ('How would you characterise the change?'). It will be considered as acceptable if the health status at least remains the same.
Measured: end of intervention, approx. after 4 months
Secondary outcomes (14)
Change in functional status as assessed by the Functional Independence Measure (FIM)
The FIM aims to evaluate the functional status of patients after a stroke throughout the rehabilitation process. It consists of 18 categories focusing on motor and cognitive function. Each category is rated on a 7-point rating scale (from 1: <25% independence to 7: 100% independence).
Measured: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Change in ambulation as assessed by the Functional Ambulation Categories (FAC)
The FAC rates ambulation ability on a six-point rating scale from zero: unable to walk or assistance by walking through two or more assistants to 5: able to walk independently everywhere.
Measured: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline
The MoCa consists of 30 items. The lowest possible score is zero, the highest is 30.
Measured: baseline
Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline
The NIHSS consists of 11 items, each item scored between zero and four, where zero indicates normal function of a specific ability, while a higher score indicates some level of impairment. The higher the total score, the severe the impairment caused by a stroke.
Measured: baseline
Change in disability level on the Modified Rankin Scale (mRS)
The mRS measures the degree of disability or dependence in daily activities in patients after a stroke using a rating scale from zero (no symptoms at all) to six (dead). The mRS score will be evaluated by the study personnel or/and by the patients via the application.
Measured: baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in self-reported disability on the Stroke Impact Scale (SIS)
The SIS is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. The SIS consists of eight subscales (strength, hand function, mobility, activity of daily living, emotion, memory, communication and participation) comprising a total of 59 questions. Patients can rate each item in terms of difficulty on five-point rating scale (from 1: could not do at all to 5: not difficult at all). Final scores range from 0 to 100. The SIS includes an extra question on how much the patient feels that he/she has recovered from stroke that is rated on a scale from 0 to 100.
Measured: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in health-related quality of life assessed by the 36-Item Short Form Healthy Survey (SF-36)
The SF-36 consists of eight sections (physical functioning, role limitations due to physical problems, general health perceptions, vitality, social functioning, role limitation due to emotional problems, general mental health, and health transition) with eight scales scores, which are the weighted sums of the questions in their subscale (0 to 100). The lower the score the higher the impairment. Patients will fill out the questions via application.
Measured: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in quality of life as assessed by the EuroQoL EQ-5D-3L
The EuroQoL consists of six questions about an individuals' quality of life in general, a visual analogue scale with a score from 0 to 100 and descriptive questions about five dimensions. Each dimension can be evaluated using a three-point rating scale (1: no problems, 2: some problems, 3: extreme problems). The descriptive system of the EQ-5D-3L produces a 5-digit health state profile, whereas the value sets are anchored on 11111 representing complete health.
Measured: baseline, end of intervention (approx. 4 months)
Life-space mobility as assessed by the German Life-Space Assessment (LSA-G)
The LSA-G consists of a questionnaire on five different life spaces: rooms besides the bedroom, area outside the house, neighbourhood, town or city lived in, outside of the town or city lived in. For each life space individuals are asked whether they visited these spaces and how often, whether they needed assistive devices or personal assistance. A life-space level can be determined as well as a composite score which ranges from 0 to 120 points (higher scores indicating better mobility).
Measured: discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in sitting balance as measured by the Trunk Impairment Scale (TIS)
The TIS assesses static (with three items) and dynamic (with four items, each repeated two or three times) sitting balance and trunk coordination (two items, each repeated twice) in sitting position in patients after a stroke . Score ranges from 0 to 23, where the higher score indicates better balance and coordination.
Measured: baseline, end of intervention (approx. 4 months)
Change in mobility assessed by the Timed Up and Go (TUG)
The TUG is a clinical tool to assess mobility and the risk of falling. The time patients need to complete the task will be measured in seconds.
Measured: baseline, end of intervention (approx. 4 months)
Blood pressure and heart rate
Blood pressure and heart rate will be measured with a digital blood pressure measurement device (Medisana BU 510, medisana GmbH, Neuss, Germany).
Measured: through study completion, up to 4 months
Change in physical performance as assessed by the Short Physical Performance Battery (SPPB)
The SPPB is a group of measures that combines the results of gait speed, chair raise and balance tests. The scores range from 0 to 12 (0: worst performance; 12: best performance).
Measured: baseline, end of intervention (approx. 4 months)
Physical activity - accelerometry
Activity data will be assessed using the GENEActiv (Activinsights, Kimbolton, UK) activity tracker. Time (in min) spent in different activity levels and steps per day will be determined.
Measured: from start of the intervention to discharge (up to 3 weeks), and last 3 weeks before end of intervention (approx. after 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start26 Jul 2024
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corina Schuster-Amft
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Corina Schuster-Amft, Reha Rheinfelden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449612
- Sponsor's protocol ID
- TeleRehaStroke
- Acronym
- TeleRehaStroke
- Status last verified
- Aug 2025
- First submitted
- 27 May 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39959919
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06449612
- Acronym / sponsor ID
- TeleRehaStroke / TeleRehaStroke
- Conditions
- Stroke
- Keywords
- Telerehabilitation, Stroke Rehabilitation, Exercise, Home-based Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corina Schuster-AmftUniversity, hospital or other
- Study start
- 26 Jul 2024 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'TeleRehaStroke' Intervention Group | Experimental | Device: TeleRehaStroke: Training programme using the 'Blended Clinic' mobile applicationThe '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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleRehaStroke: Training programme using the 'Blended Clinic' mobile applicationAlso: Blended Clinic, Blended Clinic AI, Nuremberg, Germany (https://blended.clinic/de/)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. | Device | 'TeleRehaStroke' Intervention Group |
Primary outcome
Feasibility process-related parameters: Recruitment rate
Time frame: through total study completion (up to 12 months)
The number of screened patients versus included patients. It will be considered feasible if ≥40% of informed patients will be enrolled and ≥75% of targeted sample size will be reached.
Feasibility process-related parameters: Process evaluation
Time frame: through total study completion (up to 12 months)
The absolute duration of study-related duties of study personnel/coach in minutes during the inpatient and the outpatient period will be determined.
Feasibility of training-related parameters: (Serious) adverse events and device deficiencies
Time frame: through study completion, up to 4 months
Number of adverse events (i.e., deaths, serious and non-serious adverse events as well as device deficiencies) will be reported for each patient. The criterion for success is the incidence of an adverse event in <10% of participants.
Feasibility of training-related parameters: Acceptance
Time frame: end of intervention, approx. after 4 months
Patient satisfaction will be measured with the Net Promoter Score (NPS). It involves a single question ('How likely is it that you would recommend TeleRehaStroke to a friend or colleague?' with an 11-point rating scale. It will be considered as successful if the average satisfaction is ≥50%.
Feasibility of training-related parameters: Adherence to exercise and monitoring
Time frame: through study completion, up to 4 months
Exercise adherence will be measured as the ratio of completed versus planned trainings. Monitoring adherence will be measured as the ratio of completed versus planned blood pressure measurements and activity tracker wearing time. Adherence ≥70% will be considered as successful.
Feasibility of training-related parameters: Drop-out Rate
Time frame: through total study completion (up to 12 months)
It will be defined as successful if ≥80% of enrolled participants will complete the study.
Feasibility of mHealth-related parameters: Stability and maintenance
Time frame: through total study completion (up to 12 months)
The number and description of system errors will be determined and defined as acceptable if ≤3 system failures occur per week.
Feasibility of mHealth-related parameters: Usability measured with the System Usability Scale (SUS)
Time frame: end of intervention, approx. after 4 months
The SUS consists of 10 statements considering the system evaluated on a five-point rating scale from strongly agree to strongly disagree. Scores above 70 represent an acceptable usability, with scores smaller than 50 being judged as unacceptable.
Feasibility of mHealth-related parameters: Usability measured with the German version of mHealth App Usability Questionnaire (G-MAUQ)
Time frame: end of intervention, approx. after 4 months
The G-MAUQ consists of 18 items distributed across three dimensions: ease of use, interface and satisfaction and usefulness. Using a 7-point rating scale, from 1 (strongly agree) to 7 (strongly disagree), patients rate each item. An average scoring of ≥4 will count as successful.
Feasibility of mHealth-related parameters: Quality
Time frame: end of intervention, approx. after 4 months
The user version of the Quality Assessment of Health related Apps (AQUA) consists of 31 items and assesses seven basic dimension of app-quality. All items use a five-point rating scale from 5 (strongly agree) to 1 (strongly disagree). By calculating the mean score for each dimension, the quality of an app with regard to each of the dimensions can be determined and compared. By calculating the overall mean a total score can be determined. Success is defined if the average scoring in each dimension is ≥3.
Feasibility of mHealth-related parameters: Satisfaction
Time frame: end of intervention, approx. after 4 months
Patient's subjective satisfaction will be assessed using a visual analogue scale from not satisfied at all to extremely satisfied. ('How satisfied are you with the application?'). An average satisfaction of ≥50% is considered a success.
Feasibility of mHealth-related parameters: User- and training experience:
Time frame: end of intervention, approx. after 4 months
A self-designed feedback questionnaire with a five-point rating scale (1: extremely negative to 5: extremely positive) including specific questions related to user experience, interaction with the devices, and coaching experience will be used.
Feasibility of mHealth-related parameters: Perceived change
Time frame: end of intervention, approx. after 4 months
Patients' subjective global perceived change will be assessed using a visual analogue scale (VAS) from very much worse to very much improved ('How would you characterise the change?'). It will be considered as acceptable if the health status at least remains the same.
14 secondary outcomes
Change in functional status as assessed by the Functional Independence Measure (FIM)
Time frame: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Change in ambulation as assessed by the Functional Ambulation Categories (FAC)
Time frame: baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)
Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline
Time frame: baseline
Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline
Time frame: baseline
Change in disability level on the Modified Rankin Scale (mRS)
Time frame: baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in self-reported disability on the Stroke Impact Scale (SIS)
Time frame: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in health-related quality of life assessed by the 36-Item Short Form Healthy Survey (SF-36)
Time frame: week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in quality of life as assessed by the EuroQoL EQ-5D-3L
Time frame: baseline, end of intervention (approx. 4 months)
Life-space mobility as assessed by the German Life-Space Assessment (LSA-G)
Time frame: discharge (approx. week 3), week 10, end of intervention (approx. 4 months)
Change in sitting balance as measured by the Trunk Impairment Scale (TIS)
Time frame: baseline, end of intervention (approx. 4 months)
Change in mobility assessed by the Timed Up and Go (TUG)
Time frame: baseline, end of intervention (approx. 4 months)
Blood pressure and heart rate
Time frame: through study completion, up to 4 months
Change in physical performance as assessed by the Short Physical Performance Battery (SPPB)
Time frame: baseline, end of intervention (approx. 4 months)
Physical activity - accelerometry
Time frame: from start of the intervention to discharge (up to 3 weeks), and last 3 weeks before end of intervention (approx. after 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 39959919Gaumann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleRehaStroke: Training programme using the 'Blended Clinic' mobile application in people with Stroke, run by Corina Schuster-Amft at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility process-related parameters: Recruitment rate (time frame: through total study completion (up to 12 months)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06449612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.