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

NCT06968923 | Recruiting DMC

• 1 other identifier: 1742CESC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Telemedicine; Rehabilitation; Telerehabilitation

Keywords

Stroke; telemedicine; telerehabilitation; motor; cognitive

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment Upper and Lower Limb (FMA)

  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.

  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.

Secondary Outcomes (14)

• The Trail Making Test - A (TMT-A)

  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)

  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)

  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)

  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)

  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.

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

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.

Behavioral: Telerehabilitation

Interventions

in person treatment BEHAVIORAL

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 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.

Group B

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, 37134, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Valentina Varalta

CONTACT

045 8124956; valentina.varalta@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: April 26, 2018
• Primary Completion: April 29, 2025
• Study Completion: April 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-02

Locations

IT (1)