Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT07427511

SwissNeuroRehab - HDHI

Led by Centre Hospitalier Universitaire Vaudois · Updated on 2026-03-10

120

Participants Needed

5

Research Sites

120 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire Vaudois

Lead Sponsor

M

Mindmaze SA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

SwissNeuroRehab - HDHI

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-85 years
  • Confirmed diagnosis of stroke (ischemic or hemorrhagic) more than 7 days ago
  • 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 and daily training dose
  • Willing to have assessments at start and end of program
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment
  • Uncontrolled seizure disorder or epilepsy (per clinician's judgement)
  • Any medical condition that compromises safety or exercise tolerance (such as inability to communicate, vision or hearing impairment, or heart condition)
  • Pain that limits rehabilitation dose
  • Severe apraxia
  • Severe memory disorder
  • Severe hemispatial neglect
  • Plegia of the affected limb

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Lake Lucerne Institute

Vitznau, Canton of Lucerne, Switzerland, 6354

Not Yet Recruiting

2

Klinik Valens

Valens, Canton of St. Gallen, Switzerland, 7317

Actively Recruiting

3

Centre hospitalier universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland, 1011

Actively Recruiting

4

Swiss Réhabilitation Sàrl

Sullens, Canton of Vaud, Switzerland, 1036

Actively Recruiting

5

Universitätspital Zürich

Zurich, Canton of Zurich, Switzerland, 8006

Not Yet Recruiting

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Research Team

O

Olivier Bill, MD

CONTACT

A

Andrea Serino, Prof.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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SwissNeuroRehab - HDHI | DecenTrialz