NCT07427511

SwissNeuroRehab - HDHI

SwissNeuroRehab - High Dose High Intensity Neurorehabilitation Along the Continuum of Care

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Device assisted high-dose therapy	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.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2026-02-23
• Last updated: 2026-03-10

Locations

5 sites across 1 country: Switzerland