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

NCT06449612 | Completed

• 1 other identifier: TeleRehaStroke
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Telerehabilitation; Stroke Rehabilitation; Exercise; Home-based Rehabilitation

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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%.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  end of intervention, approx. after 4 months

Secondary Outcomes (14)

• Change in functional status as assessed by the Functional Independence Measure (FIM)

  baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)

• Change in ambulation as assessed by the Functional Ambulation Categories (FAC)

  baseline, discharge (approx. 3 weeks), end of intervention (approx. 4 months)

• Cognition assessed by the Montreal Cognitive Assessment (MoCA) at baseline

  baseline

• Level of impairment assessed by the National Institute of Health Stroke Scale (NIHSS) at baseline

  baseline

• Change in disability level on the Modified Rankin Scale (mRS)

  baseline, week 1, discharge (approx. week 3), week 10, end of intervention (approx. 4 months)

Study Arms (1)

'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.

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

Interventions

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

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

'TeleRehaStroke' Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corina Schuster-Amft: lead

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39959919 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Department

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 10, 2024
• Study Start: July 26, 2024
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)