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StrokeSNR-HDHINCT07427511

SwissNeuroRehab - HDHI

A study testing Device assisted high-dose therapy in people with Stroke, run by Centre Hospitalier Universitaire Vaudois at 5 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Device assisted high-dose therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesSwitzerland
Study dates
10 Feb 2026to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Olivier Bill, MD contact

+41 0213141260

olivier.bill@chuv.ch

Andrea Serino, Prof. contact

+41 21 314 3996

andrea.serino@chuv.ch

5 sites in 1 country

Switzerland5 sites, 5 recruiting

  • Centre hospitalier universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

    Olivier Bill, +41 0213141260, olivier.bill@chuv.ch

    Olivier Bill, MD

    Recruiting

  • Swiss Réhabilitation Sàrl

    Sullens, Canton of Vaud, 1036

    Nicolas Perret, +41 021 866 66 75, nicolas.perret@hesav.ch

    Nicolas Perret

    Recruiting

  • Klinik Valens

    Valens, Canton of St. Gallen, 7317

    Jens Bansi, Dr., +41 585101302, jens.bansi@kliniken-valens.ch

    Jens Bansi, Dr.

    Recruiting

  • Lake Lucerne Institute

    Vitznau, Canton of Lucerne, 6354

    Christoph Bauer, PhD., +41 79 527 24 49, christoph.bauer@llui.org

    Christoph Bauer, PhD

    Not yet recruiting

  • Universitätspital Zürich

    Zurich, Canton of Zurich, 8006

    Andreas Luft, Prof., +41 0798626436, andreas.luft@usz.ch

    Andreas Luft, Prof.

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: SwissNeuroRehab - High Dose High Intensity Neurorehabilitation Along the Continuum of Care

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.

Read more

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.

Conditions
Stroke
Being tested
Device assisted high-dose therapy
Keywords
high dose, intensive therapy
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Device assisted high-dose therapyBehavioural

    Also called Device assisted high-dose neurorehabilitation

    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.

Study groups in NCT07427511
Study groupRoleWhat they receive
Device assisted high-dose therapyExperimentalParticipants receive a high-dose, high-intensity (HDHI) motor rehabilitation program supported by digital therapeutic devices, delivered across inpatient, outpatient and home-based settings.
Receives: Behavioral: Device assisted high-dose therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

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

Secondary outcomes (11)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  5. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  6. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  7. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  8. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  9. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  10. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

  11. 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.

    Measured: From baseline to follow-up assessments up to 15 months post-inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start10 Feb 2026 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07427511
Sponsor's protocol ID
BPR1243
Other IDs
2025-00413, 2025
Acronym
SNR-HDHI
Status last verified
Mar 2026
First submitted
22 Jan 2026
Last updated
10 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sokolov AA, Serino A. SWISSNEUROREHAB - Technologie-assistiertes Continuum of Care in der Schweizer Neurorehabilitation. Neurol Rehabil. 2024;30(S1):28-29

Questions about this trial

What is this clinical trial studying?

A study testing Device assisted high-dose therapy in people with Stroke, run by Centre Hospitalier Universitaire Vaudois at 5 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivier Bill, MD (+41 0213141260, olivier.bill@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HDHI training adherence (Active Training Time, ATT) (time frame: Weekly during the intervention period (up to 18 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07427511, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.

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