SwissNeuroRehab - HDHI

NCT07427511 | Recruiting

• 2 other identifiers: BPR12432025-00413
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke

Keywords

high dose; intensive therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (11)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

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

• Action Research Arm Test (ARAT)

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

• Extended Barthel Index (eBI)

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

• Functional Independence Measure (FIM)

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

• Modified Rankin Scale (mRS)

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

Other Outcomes (36)

• Patient Global Impression of Change (PGIC)

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

• Pain Visual Analog Scale (VAS)

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

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

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

Study Arms (1)

Device assisted high-dose therapy

EXPERIMENTAL

Participants receive a high-dose, high-intensity (HDHI) motor rehabilitation program supported by digital therapeutic devices, delivered across inpatient, outpatient and home-based settings.

Behavioral: Device assisted high-dose therapy

Interventions

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.

Also known as: Device assisted high-dose neurorehabilitation

Device assisted high-dose therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead
• Mindmaze SA: collaborator
• Innosuisse - Swiss Innovation Agency: collaborator
• Cereneo AG: collaborator

Study Sites (5)

Lake Lucerne Institute

Vitznau, Canton of Lucerne, 6354, Switzerland

NOT YET RECRUITING

Klinik Valens

Valens, Canton of St. Gallen, 7317, Switzerland

RECRUITING

Centre hospitalier universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Swiss Réhabilitation Sàrl

Sullens, Canton of Vaud, 1036, Switzerland

RECRUITING

Universitätspital Zürich

Zurich, Canton of Zurich, 8006, Switzerland

NOT YET RECRUITING

Related Publications (1)

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Stroke

Interventions

Therapeutics; Neurological Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrea Serino, Prof.

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Central Study Contacts

Olivier Bill, MD

CONTACT

+41 0213141260; olivier.bill@chuv.ch

Andrea Serino, Prof.

CONTACT

+41 21 314 3996; andrea.serino@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: February 23, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (5)