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

University of Verona

Status: Enrolling

Conditions: Rehabilitation; Telerehabilitation; Stroke; Telemedicine

Treatments: Behavioral: Telerehabilitation; Behavioral: in person treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06968923

1742CESC

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Group A

Active Comparator group

Description:

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.

Group B

Experimental group

Description:

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.

Treatment:

Behavioral: Telerehabilitation