Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversita di Verona
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
in person treatment
BehavioralThe 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
BehavioralThe 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Group AActive comparator 0 interventions
Group B: Group BExperimental treatment 1 intervention
Trial outcomes
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.
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 outcomes
1
The Trail Making Test - A (TMT-A)
Used as a measure of psychomotor speed and visual search/attention skills
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.2
Trail Making Test Part B (TMT-B)
Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
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.3
Berg Balance Scale (BBS)
A clinical assessment of balance that assigns an overall score ranging from 0 to 56, where a higher score indicates good balance control and a reduced risk of falls.
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.4
10 Meters Walking Test (10MWT)
An assessment that measures a person's walking speed over a distance of 10 meters. During the test, the patient walks at a comfortable pace, and the time taken to cover the 10 meters is recorded.
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.Sponsors and contacts
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Source ClinicalTrials.gov