Clinical trial NCT06968923: Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device
Official title: Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Telemedicine
Rehabilitation
Telerehabilitation
Keywords: Stroke
telemedicine
telerehabilitation
motor
cognitive
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Fugl-Meyer Assessment Upper and Lower Limb (FMA)
timeFrame: 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:
measure: The Trail Making Test - A (TMT-A)
timeFrame: 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.
measure: Trail Making Test Part B (TMT-B)
timeFrame: 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.
measure: Berg Balance Scale (BBS)
timeFrame: 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.
measure: 10 Meters Walking Test (10MWT)
timeFrame: 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.
measure: Timed Up and Go (TUG)
timeFrame: 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.
measure: Barthel Index (BI)
timeFrame: 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.
measure: Short Form - 36 (SF-36)
timeFrame: 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.
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: The test is administered after five weeks of treatment, and four weeks post-treatment.
measure: Oxford Cognitive Screen (OCS)
timeFrame: 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.
measure: Digit Span Forward (DSF)
timeFrame: 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.
measure: Digit Span Backward
timeFrame: 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.
measure: Frontal Assessment Battery (FABit)
timeFrame: 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.
measure: Symbol Digit Modalities Test
timeFrame: 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.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Study officials:
References: