About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Device assisted high-dose therapy
Behavioral
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.

Treatment groups

120 Participants

are divided into 1 treatment group

Group A: Device assisted high-dose therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

HDHI 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)

2

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

Secondary outcomes

1

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

2

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

3

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

4

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

Other outcomes

1

Patient Global Impression of Change (PGIC)

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.

Time frame

At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion

2

Pain Visual Analog Scale (VAS)

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.

Time frame

From baseline to follow-up assessments up to 12 months post-discharge

3

EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

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.

Time frame

From baseline to follow-up assessments up to 12 months post-discharge

4

PROMIS Global-10

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.

Time frame

From baseline to follow-up assessments up to 12 months post-discharge

SwissNeuroRehab - HDHI

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts