High-dose, high-intensity (HDHI) neurorehabilitation has shown promise for improving functional outcomes after acquired brain injury (ABI), yet its feasibility and impact across different stages of care and real-world clinical settings remain insufficiently understood. The SwissNeuroRehab (SNR) initiative, bringing together Swiss rehabilitation centres to develop and evaluate innovative, technology-supported models of neurorehabilitation, provides the broader framework within which this study is conducted. Within this framework, a structured HDHI therapy pathway supported by CE-marked digital neurorehabilitation tools has been developed for delivery across inpatient, outpatient, and home environments in Switzerland. This multicentre, non-randomised interventional feasibility study evaluates the feasibility and preliminary clinical effects of implementing this HDHI rehabilitation pathway for adults with stroke in subacute and chronic stages. Participants will receive approximately 300 minutes per week of active, technology-supported training in addition to standard rehabilitation care, following an individually tailored pathway across settings. Standardised clinical assessments, patient-reported outcomes, documentation of rehabilitation procedures, and socioeconomic measures will be collected at baseline, discharge, and follow-up timepoints up to 12-15 months post-enrollment. The primary aim of the study is to assess the feasibility of the HDHI intervention within routine rehabilitation workflows across multiple Swiss centres. Feasibility will be evaluated through (i) adherence to at least half of the weekly 300-minute Active Training Time target and (ii) patients' perceived feasibility and satisfaction with the program. Secondary aims are to explore preliminary clinical and functional changes, patient-reported outcomes, and quantify socioeconomic impacts through dedicated surveys and cost data. Findings from this study will (i) determine whether a structured HDHI rehabilitation pathway can be feasibly implemented across diverse clinical contexts, (ii) provide initial estimates of clinical and socioeconomic outcomes to support planning of future controlled trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Participants undergo a high-dose, high-intensity (HDHI) neurorehabilitation program using CE-marked digital therapeutic devices (MindMotion GO, Izar). The intervention is tailored to individual motor rehabilitation needs and delivered across settings: during inpatient rehabilitation (4-6 weeks) and/or home-based outpatient care (8-12 weeks). Participants are expected to train actively for approximately one hour per day (5day week), supported by clinical staff and if applicable, caregivers.The intervention is supervised by clinical teams specifically trained in the HDHI protocol, who provide ongoing therapeutic support and monitor progress across settings.
Lake Lucerne Institute
Vitznau, Canton of Lucerne, Switzerland
NOT_YET_RECRUITINGKlinik Valens
Valens, Canton of St. Gallen, Switzerland
RECRUITINGCentre hospitalier universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland
RECRUITINGSwiss Réhabilitation Sàrl
Sullens, Canton of Vaud, Switzerland
RECRUITINGUniversitätspital Zürich
Zurich, Canton of Zurich, Switzerland
NOT_YET_RECRUITINGHDHI training adherence (Active Training Time, ATT)
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.
Time frame: Weekly during the intervention period (up to 18 weeks)
Feasibility and satisfaction with the HDHI program (Program Feasibility and Satisfaction Questionnaire)
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.
Time frame: At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Action Research Arm Test (ARAT)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Extended Barthel Index (eBI)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Functional Independence Measure (FIM)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Modified Rankin Scale (mRS)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Grip Strength - Hand Dynamometry
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Mini Balance Evaluation Systems Test (Mini-BESTest)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
10-Meter Walk Test (10mWT)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
6-Minute Walk Test (6MWT)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Timed Up and Go test (TUG)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
Five Times Sit-to-Stand test (5xSTS)
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.
Time frame: From baseline to follow-up assessments up to 15 months post-inclusion
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