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.

Overview

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.

Interventions

• Behavioral 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.
• 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.

Primary outcome measures

• Fugl-Meyer Assessment Upper and Lower Limb (FMA) [Time frame: 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 outcome measures (12)

• The Trail Making Test - A (TMT-A) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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.]
• Barthel Index (BI) [Time frame: 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.]
• Short Form - 36 (SF-36) [Time frame: 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.]
• Client Satisfaction Questionnaire (CSQ-8) [Time frame: The test is administered after five weeks of treatment, and four weeks post-treatment.]
• Oxford Cognitive Screen (OCS) [Time frame: 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.]
• Digit Span Forward (DSF) [Time frame: 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.]
• Digit Span Backward [Time frame: 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.]
• Frontal Assessment Battery (FABit) [Time frame: 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione — Verona

Identifiers

NCT: NCT06968923 · 1742CESC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗