SwissNeuroRehab - HDHI

The adherence to ≥150 minutes per week of Active Training Time (ATT), corresponding to at least half of the predefined weekly target of 300 minutes/week. ATT is derived from device-recorded active training logs and aggregated by calendar week during the intervention period. Weekly ATT is summarized across the intervention period to determine whether participants meet the predefined weekly adherence criterion.

The perceived feasibility and patient satisfaction with the HDHI program, assessed using a study-specific Program Feasibility and Satisfaction Questionnaire consisting of 12 Likert-scale items covering accessibility/ease of use, pleasant content, empowerment capability, self-efficacy, alignment with clinical objectives, alignment with personal values and culture, environmental context, trust in the program, and perceived personal value. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). A total score is calculated by summing item scores, with a minimum possible score of 12 and a maximum possible score of 60; higher scores indicate greater perceived feasibility and satisfaction.

Upper-limb motor impairment measured using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The motor domain of the FMA-UE consists of 33 items assessing upper-limb motor function, with a total score ranging from 0 to 66; higher scores indicate better motor function and less motor impairment.

Upper-limb functional performance measured using the Action Research Arm Test (ARAT). The ARAT consists of 19 items across grasp, grip, pinch, and gross movement domains, with each item scored from 0 to 3, resulting in a total score ranging from 0 to 57; higher scores indicate better upper-limb functional performance.

Activities of daily living performance measured using the Extended Barthel Index (eBI). The eBI assesses functional independence in activities of daily living using a 16-item scale, with a total score ranging from 0 to 64; higher scores indicate greater independence and better activities of daily living performance.

Functional independence measured using the Functional Independence Measure (FIM). The FIM is an 18-item scale assessing independence in activities of daily living, with each item scored from 1 to 7, resulting in a total score ranging from 18 to 126; higher scores indicate greater functional independence.

Global disability measured using the Modified Rankin Scale (mRS). The mRS is a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death), used to assess the level of functional disability and dependence in daily activities; higher scores indicate greater disability and worse functional outcome.

Grip strength of the affected hand measured using a Jamar hand dynamometer. Maximum voluntary grip strength is recorded in kilograms (kg), calculated as the mean of three trials; higher values indicate greater grip strength.

Balance performance measured using the Mini Balance Evaluation Systems Test (Mini-BESTest). The Mini-BESTest consists of 14 items, each scored from 0 to 2, assessing dynamic balance across anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait, with a total score ranging from 0 to 28; higher scores indicate better balance performance.

Gait speed measured using the 10-Meter Walk Test (10mWT) performed at self-selected walking speed. Gait speed is calculated in meters per second (m/s); higher values indicate faster walking speed and better gait performance.

Gait endurance measured using the 6-Minute Walk Test (6MWT). Endurance is quantified as the total distance walked in meters during the 6-minute test period; higher values indicate greater walking endurance and better gait performance.

Functional mobility measured using the Timed Up and Go test (TUG). Performance is quantified as the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down, measured in seconds (s); lower values indicate better functional mobility.

Lower-limb functional strength and balance measured using the Five Times Sit-to-Stand test (5xSTS). Performance is quantified as the time required to stand up from and sit down on a chair five times consecutively, measured in seconds (s); lower values indicate better lower-limb functional performance.

Participant's global perception of change in overall health status measured using the Patient Global Impression of Change (PGIC) scale. The PGIC is a 7-point ordinal scale ranging from 1 (very much worse) to 7 (very much improved); higher scores indicate greater perceived improvement.

Self-reported pain intensity measured using a Visual Analog Scale (VAS). Pain intensity is rated on a numeric scale ranging from 0 (no pain) to 100 (worst pain imaginable); higher scores indicate greater pain intensity.

Health-related quality of life measured using the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses health status across five dimensions, each rated on five ordered levels (1 = no problems to 5 = extreme problems). Responses are combined to derive an EQ-5D-5L index score; higher index values indicate better health-related quality of life.

Self-reported global physical and mental health status measured using the PROMIS Global Health (Global-10) questionnaire. The instrument yields two summary scores: Global Physical Health (GPH) raw score and Global Mental Health (GMH) raw score. Each summary score has a raw score range from 4 to 20; higher scores indicate better health status.

Stroke-specific impact on daily life and participation measured using the Short Form Stroke Impact Scale (SF-SIS). The SF-SIS is a patient-reported questionnaire assessing the perceived impact of stroke on physical function, activities, cognition, communication, emotion, and participation using ordered response categories; higher scores indicate better function and less perceived impact of stroke.

Self-reported occurrence of falls and sleep-related characteristics assessed using a study-specific modified falls and sleep questionnaire. Falls outcomes include the number of falls, number of falls resulting in injury, and number of falls requiring hospitalisation during the preceding month. Sleep-related outcomes include self-reported interference of sleep problems with daily functioning, assessed using an ordinal response scale, where higher ratings indicate greater interference.

Health-related risk and well-being characteristics assessed using selected items from the Behavioral Risk Factor Surveillance System (BRFSS). Outcomes include the number of days in the past 30 days during which participants report poor physical health, poor mental health, and activity limitation due to poor physical or mental health, recorded as counts of days (0-30). Higher values indicate a greater number of unhealthy days.

Socio-economic characteristics and health resource use assessed using a study-specific structured socio-economic questionnaire and rehabilitation-related resource use data. Variables include employment status, living situation, support needs, and use of rehabilitation and healthcare services, reported descriptively.

Exposure to standard rehabilitation care and additional physical exercise assessed using a study-specific structured questionnaire and/or exercise diary. Variables include the type, frequency, and duration of rehabilitation and physical activities performed outside the HDHI program, reported descriptively.

Feasibility of HDHI program delivery assessed using program-specific documentation, including enrollment records, completion status, and discharge documentation. Feasibility outcomes include the number and proportion of participants who initiate the program, complete the intervention, and discontinue prematurely, reported descriptively.

Training dose delivery assessed using device-recorded session logs. Outcomes include total active training time, number of completed sessions, and distribution of training across modalities, summarized descriptively over the intervention period.

Systolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures.

Diastolic blood pressure measured in millimeters of mercury (mmHg) using standard clinical procedures.

Heart rate measured in beats per minute (bpm) using standard clinical procedures.

Peripheral oxygen saturation measured as percentage of hemoglobin oxygen saturation (%) using pulse oximetry.

Memory domain: Verbal short-term memory and attention span, assessed using the Digit Span Forward task. Performance is defined as the maximum correctly recalled digit sequence length; Performance is reported as a standardized score derived from test norms (e.g., T-score).

Working memory domain: Verbal working memory involving mental manipulation, assessed using the Digit Span Backward task. Performance is reported as a standardized score derived from test norms (e.g., T-score), with higher scores indicating better working memory performance.

Memory domain: Visuospatial short-term memory, assessed using the Block Span (Corsi Block-Tapping) Test. Performance is reported as a standardized score based on normative data, with higher scores indicating better visuospatial working memory.

Non-lateralized attention (processing speed domain): visual scanning and psychomotor processing speed assessed using the Trail Making Test Part A. Performance is reported using standardized scores based on completion time, with higher scores indicating better performance.

Executive function domain: cognitive flexibility and set shifting assessed using the Trail Making Test Part B under speeded visuomotor conditions. Performance is reported using standardized scores, with higher scores indicating better cognitive flexibility.

Non-lateralized attention (processing speed domain): visual scanning and psychomotor processing speed assessed using the Color Trails Test Part 1. The Color Trails Test is used as a language-reduced alternative to the Trail Making Test Part A in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from test norms, with higher scores indicating better performance.

Executive function domain: cognitive flexibility and set shifting assessed using the Color Trails Test Part 2 under speeded visuomotor conditions. The Color Trails Test is used as a language-reduced alternative to the Trail Making Test Part B in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from test norms, with higher scores indicating better cognitive flexibility.

Executive function domain: figural fluency assessed using the Five-Point Test, reflecting nonverbal generative fluency and self-monitoring. Performance is reported as a standardized score derived from the number of unique designs produced, with higher scores indicating better figural fluency.

Executive function domain: phonemic verbal fluency assessed by the ability to generate words according to phonemic constraints within a fixed time period. Performance reflects executive control of lexical retrieval and self-monitoring and is reported as a standardized score, with higher scores indicating better phonemic fluency.

Executive function domain: semantic verbal fluency assessed by the ability to generate words within a semantic category during a fixed time period. Performance primarily reflects semantic memory retrieval supported by executive control processes and is reported as a standardized score, with higher scores indicating better semantic fluency.

Executive function domain: interference control assessed using the Stroop Color-Word Test. Performance reflects the ability to resolve cognitive interference under competing stimulus conditions and is reported as a standardized score derived from response time and error measures, with higher scores indicating better interference control.

Executive function domain: motor response inhibition assessed using the Go/No-Go subtest of the Test of Attentional Performance (TAP). This task is used as a language-independent alternative to the Stroop test in participants with aphasia or limited literacy. Performance is reported as a standardized score derived from error rates and reaction time measures, with higher scores indicating better response inhibition.

Non-lateralized attention domain: tonic alertness assessed using the Alertness subtest of the Test of Attentional Performance (TAP). Performance reflects baseline response readiness and is reported as a standardized score derived from reaction time measures, with higher scores indicating better alertness.

Non-lateralized attention domain: divided attention assessed using the Divided Attention subtest of the Test of Attentional Performance (TAP). Performance reflects the ability to allocate attentional resources across concurrent tasks and is reported as a standardized score derived from reaction time and/or error measures, with higher scores indicating better divided attention.

Executive-attentional domain: attentional flexibility assessed using the Shift of Focus (Flexibility) subtest of the Test of Attentional Performance (TAP). Performance reflects the ability to shift attentional focus between task-relevant stimuli and is reported as a standardized score derived from reaction time and/or error measures, with higher scores indicating better attentional flexibility.

Lateralized attention domain: visuospatial attention bias assessed using the Apples Test, which dissociates egocentric and allocentric spatial attention deficits. Performance is reported using standardized asymmetry indices derived from cancellation accuracy, with greater symmetry indicating better spatial attention.

Working memory domain: Self-reported working-memory-related difficulties in everyday functioning assessed using a standardized Working Memory Questionnaire. Scores are reported according to the questionnaire scoring manual, with higher scores indicating greater perceived working-memory difficulties.

Depression and anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), a 14-item questionnaire with two 7-item subscales (Anxiety and Depression). Each item is scored 0-3; subscale scores range 0-21 and total score ranges 0-42, with higher scores indicating greater symptom severity.

Fatigue assessed using the Fatigue Scale for Motor and Cognitive Functions (FSMC), a 20-item self-report questionnaire comprising motor and cognitive fatigue subscales. Items are rated on an ordered response scale, and subscale and total scores are calculated according to the scoring manual, with higher scores indicating greater fatigue severity.

Spasticity assessed using the Modified Ashworth Scale (MAS) for specified joints (shoulder, elbow, wrist, hip, knee, ankle, fingers). MAS is scored on an ordinal scale (0, 1, 1+, 2, 3, 4), where higher scores indicate greater resistance to passive movement (greater spasticity).

Voluntary muscle strength assessed using manual Muscle Strength Testing (MST) of upper and lower limbs according to standardized site procedures. Muscle strength is recorded as ordinal strength grades for predefined muscle groups of the upper and lower extremities, with higher grades indicating greater muscle strength.