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

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.

The absolute duration of study-related duties of study personnel/coach in minutes during the inpatient and the outpatient period will be determined.

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.

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%.

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.

It will be defined as successful if ≥80% of enrolled participants will complete the study.

The number and description of system errors will be determined and defined as acceptable if ≤3 system failures occur per week.

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.

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.

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.

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.

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.

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.

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).

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.

The MoCa consists of 30 items. The lowest possible score is zero, the highest is 30.

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.

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.

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.

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.

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.

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).

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.

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.

Blood pressure and heart rate will be measured with a digital blood pressure measurement device (Medisana BU 510, medisana GmbH, Neuss, Germany).

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).

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.