RecruitingNot ApplicableNCT06968923

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

Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.


Sponsor

Universita di Verona

Enrollment

90 participants

Start Date

Apr 26, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria6

  • 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 Criteria5

  • 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.

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Interventions

BEHAVIORALin 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.

BEHAVIORALTelerehabilitation

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.


Locations(1)

Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione

Verona, verona, Italy

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NCT06968923


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