| NCT ID | NCT07427511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire Vaudois |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-02-10 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andrea Serino, Prof.
STUDY CHAIR
Centre Hospitalier Universitaire Vaudois
Frequently Asked Questions
Who can join the NCT07427511 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07427511 currently recruiting?
Yes, NCT07427511 is actively recruiting participants. Contact the research team at olivier.bill@chuv.ch for enrollment information.
Where is the NCT07427511 trial being conducted?
This trial is being conducted at Vitznau, Switzerland, Valens, Switzerland, Lausanne, Switzerland, Sullens, Switzerland and 1 additional location.
Who is sponsoring the NCT07427511 clinical trial?
NCT07427511 is sponsored by Centre Hospitalier Universitaire Vaudois. The principal investigator is Andrea Serino, Prof. at Centre Hospitalier Universitaire Vaudois. The trial plans to enroll 120 participants.
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