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

NCT ID: NCT06968923

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-26

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Telemedicine Rehabilitation Telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A

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 Type ACTIVE_COMPARATOR

No interventions assigned to this group

Group B

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.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universita di Verona

OTHER

Sponsor Role lead

Responsible Party

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Nicola Smania, MD, Clinical Professor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina Varalta

Role: CONTACT

045 8124956

Facility Contacts

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Valentina Varalta, Doctor

Role: primary

045 8124956

Other Identifiers

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1742CESC

Identifier Type: -

Identifier Source: org_study_id

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