Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device

Официальное название

Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.

Обзор

To verify the non-inferiority, in terms of post-treatment (T1) clinical effectiveness, of a "multidomain" telerehabilitation (TR) protocol compared to conventional outpatient rehabilitation in patients with stroke sequelae, with respect to motor, cognitive, and language functions. The absence of statistically significant differences between the two groups regarding treatment effects for each targeted domain will be considered an indicator of non-inferiority.

Вмешательства

• Поведенческое in person treatment
  The group undergoes a 5-week treatment, twice a week, for a total of 10 rehabilitation sessions. Each session lasts approximately 60 minutes. The treatment follows standard in-person clinical practice.
• Поведенческое Telerehabilitation
  The group undergoes a 5-week treatment, with 2 hours per week, for a total of 10 hours at home. Each session lasts approximately 20 minutes. The treatment consists of a sequence of exercises performed using the Euleria Home® device, a medical software that enables the delivery of personalized exercise therapy programs designed by a healthcare professional.

Первичные конечные точки

• Fugl-Meyer Assessment Upper and Lower Limb (FMA) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]

Вторичные конечные точки (12)

• The Trail Making Test - A (TMT-A) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Trail Making Test Part B (TMT-B) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Berg Balance Scale (BBS) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• 10 Meters Walking Test (10MWT) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Timed Up and Go (TUG) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Barthel Index (BI) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Short Form - 36 (SF-36) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Client Satisfaction Questionnaire (CSQ-8) [Срок оценки: The test is administered after five weeks of treatment, and four weeks post-treatment.]
• Oxford Cognitive Screen (OCS) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Digit Span Forward (DSF) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Digit Span Backward [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]
• Frontal Assessment Battery (FABit) [Срок оценки: The test is administered at the beginning of the treatment (> six months after the event), after five weeks of treatment, and four weeks post-treatment.]

Критерии участия

Критерии включения

• Age over 18 years.
• First diagnosis of ischemic stroke, documented radiologically via CT or MRI scans, corresponding to ICD-9-CM codes 433 and 434 .
• Presence of aphasia, as assessed by the Aachener Aphasia Test (AAT), and/or cognitive deficits identified through the Oxford Cognitive Screen (OCS).
• Availability of an ADSL or higher-speed internet connection at the patient's residence.
• Ability of the patient and/or caregiver to understand and utilize the telerehabilitation system.
• Provision of written informed consent.

Критерии исключения

• Contemporanea partecipazione ad altri studi clinici;
• Decadimento cognitivo
• Deformità ossee come conseguenza di precedenti eventi traumatici ai 4 arti;
• Contratture fisse ai 4 arti valutate come 4/4 alla scala di Ashworth modificata (MAS)
• Altre patologie neurologiche e ortopediche in grado di interferire con lo studio.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione — Verona

Идентификаторы

NCT: NCT06968923 · 1742CESC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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