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.
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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Fugl-Meyer Assessment Upper and Lower Limb (FMA) — 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. The Fugl-Meyer Assessment (FMA) is a widely used observational scale for evaluating motor recovery in patients with stroke sequelae. In its version focused on the upper and lower limbs, the FMA measures motor control by assessing specific movements of the shoulder, elbow, wrist, hand, hip, knee, and ankle. Each movement is rated on a three-point scale (0 = absent, 1 = partial, 2 = complete). The maximum score is 66 points for the upper limb and 34 for the lower limb, for a total of 100 points in the overall motor function assessment. Higher scores indicate a greater degree of recovery.
Trial sites (1)
Facility
City
Region
Status
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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