Stroke
Conditions
Keywords
high dose, intensive therapy
Brief summary
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.
Interventions
BEHAVIORALDevice assisted high-dose therapy
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.
Sponsors
Centre Hospitalier Universitaire Vaudois
Mindmaze SA
Innosuisse - Swiss Innovation Agency
Cereneo AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-group, multicenter interventional feasibility study evaluating the implementation of a high-dose, high-intensity (HDHI) motor rehabilitation program in routine clinical care. All enrolled participants receive the same intervention. The study focuses on feasibility, adherence, and clinical outcomes associated with delivery of the HDHI program across different care settings.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-85 years. * Confirmed diagnosis of stroke (ischemic or hemorrhagic) \>7 days ago * Be able to sit unassisted * Able and willing to give informed consent * Have motor difficulties of the Upper Extremity and/or Lower Extremity * Willing to commit to program length \& daily training dose * Willing to have assessments at start and end of program * Signed informed consent
Exclusion criteria
* Severe cognitive impairment * Uncontrolled seizure disorder or epilepsy - clinician's judgement) * Any medical condition that would compromise their safety (inability to communicate, vision or hearing impairment, heart condition that limits participation in exercise) and tolerability (cardiac contraindications) * Pain that would limit rehabilitation dose * Severe apraxia * Severe memory disorder * Severe hemispatial neglect * Plegia of the affected limb
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HDHI training adherence (Active Training Time, ATT) | Weekly during the intervention period (up to 18 weeks) | 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. |
| Feasibility and satisfaction with the HDHI program (Program Feasibility and Satisfaction Questionnaire) | At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity (FMA-UE) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Action Research Arm Test (ARAT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Extended Barthel Index (eBI) | From baseline to follow-up assessments up to 15 months post-inclusion | 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 Measure (FIM) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Modified Rankin Scale (mRS) | From baseline to follow-up assessments up to 15 months post-inclusion | 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 - Hand Dynamometry | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Mini Balance Evaluation Systems Test (Mini-BESTest) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| 10-Meter Walk Test (10mWT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| 6-Minute Walk Test (6MWT) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Timed Up and Go test (TUG) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
| Five Times Sit-to-Stand test (5xSTS) | From baseline to follow-up assessments up to 15 months post-inclusion | 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. |
Countries
Switzerland
Contacts
CONTACTOlivier Bill, MD
CONTACTAndrea Serino, Prof.
STUDY_CHAIRAndrea Serino, Prof.
Centre Hospitalier Universitaire Vaudois
Outcome results
None listed