SwissNeuroRehab - HDHI

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 in

Первичные конечные точки

• HDHI training adherence (Active Training Time, ATT) [Срок оценки: Weekly during the intervention period (up to 18 weeks)]
• Feasibility and satisfaction with the HDHI program (Program Feasibility and Satisfaction Questionnaire) [Срок оценки: At discharge from the intervention and at follow-up assessments up to 15 months post-inclusion]

Вторичные конечные точки (11)

• Fugl-Meyer Assessment - Upper Extremity (FMA-UE) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Action Research Arm Test (ARAT) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Extended Barthel Index (eBI) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Functional Independence Measure (FIM) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Modified Rankin Scale (mRS) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Grip Strength - Hand Dynamometry [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Mini Balance Evaluation Systems Test (Mini-BESTest) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• 10-Meter Walk Test (10mWT) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• 6-Minute Walk Test (6MWT) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Timed Up and Go test (TUG) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]
• Five Times Sit-to-Stand test (5xSTS) [Срок оценки: From baseline to follow-up assessments up to 15 months post-inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 5 центров

• Lake Lucerne Institute — Vitznau
• Klinik Valens — Valens
• Centre hospitalier universitaire Vaudois — Lausanne
• Swiss Réhabilitation Sàrl — Sullens
• Universitätspital Zürich — Zurich

Публикации

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

Идентификаторы

NCT: NCT07427511 · BPR1243 · 2025-00413

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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