Actively Recruiting
Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home ae Device: A Crossover Study.
Led by Universita di Verona · Updated on 2025-05-13
90
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a home-based telerehabilitation program using the Euleria Home ae device is as effective as conventional outpatient rehabilitation for stroke survivors. The study focuses on motor, cognitive, and language functions in patients with stroke sequelae, aiming to demonstrate non-inferiority of the telerehabilitation approach compared to standard in-person care. Participants are randomly assigned to one of two groups: one receives a 5-week in-person rehabilitation program with two 60-minute sessions per week, totaling 10 sessions; the other group undergoes a 5-week home-based telerehabilitation program using the Euleria Home ae device, completing 10 hours of therapy at about 20 minutes per session, twice a week. Both treatments are personalized and designed by healthcare professionals. During the study, participants undergo multiple assessments including the Fugl-Meyer Assessment for limbs, cognitive tests like the Oxford Cognitive Screen, and functional evaluations such as the Berg Balance Scale and 10 Meters Walking Test. These tests are administered at baseline, after five weeks of treatment, and four weeks post-treatment. Researchers also measure patient satisfaction and monitor anxiety and depression levels. The entire participation period includes treatment and follow-up assessments over approximately nine weeks.
CONDITIONS
Brief Title
Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- First diagnosis of ischemic stroke confirmed by CT or MRI scans
- Presence of aphasia and/or cognitive deficits as assessed by specific tests
- Availability of ADSL or higher-speed internet connection at home
- Ability of patient and/or caregiver to use the telerehabilitation system
- Provision of written informed consent
You will not qualify if you...
- Current participation in other clinical studies
- Cognitive decline
- Bone deformities due to previous trauma in all four limbs
- Fixed contractures in all four limbs assessed as 4/4 on the modified Ashworth scale
- Other neurological or orthopedic conditions that may interfere with the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants undergo a 5-week treatment period. One group receives in-person rehabilitation sessions twice a week, totaling 10 sessions of about 60 minutes each. The other group completes a home-based telerehabilitation program using the Euleria Home® device for 2 hours per week, totaling 10 hours of personalized exercise therapy.
Twice weekly visits for in-person treatment; home exercises totaling 2 hours per week for telerehabilitation
Duration - 4 weeks
Participants are assessed for outcomes and satisfaction four weeks after completing the treatment period.
1 follow-up visit (in-person or remote)
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, Italy, 37134
Actively Recruiting
Research Team
V
Valentina Varalta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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