StrokeNCT06968923
Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device
A study testing in person treatment and Telerehabilitation in people with Stroke and Telemedicine, run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Telemedicine, Rehabilitation
- What is being tested?
- in person treatment and Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2018to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - UOC di Neuroriabilitazione
Verona, verona, 37134
Valentina Varalta, Doctor, 045 8124956, valentina.varalta@univr.it
About this study
Official title: Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.
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.
- Conditions
- Stroke, Telemedicine, Rehabilitation, Telerehabilitation
- Being tested
- in person treatment, Telerehabilitation
- Keywords
- Stroke, telemedicine, telerehabilitation, motor, cognitive
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in person treatmentBehavioural
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.
TelerehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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. |
| Group B | Experimental | 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. Receives: Behavioral: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (14)
The Trail Making Test - A (TMT-A)
Used as a measure of psychomotor speed and visual search/attention skills
Measured: 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)
Used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
A test to measure a person's level of mobility, requiring both static and dynamic balance skills. It measures the time it takes for a person to stand up from a chair, walk three meters, turn around, return to the chair, and sit down again.
Measured: 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)
A scale used to assess a person's autonomy in daily activities, such as eating, dressing, walking, and other motor and self-care functions. Composed of 10 items, the score ranges from 0 to 100, with higher scores indicating greater independence in daily activities, while lower scores reflect greater dependence or the need for assistance.
Measured: 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)
A questionnaire used to assess changes in a person's health status, considering various dimensions of physical and mental well-being. Composed of 36 questions, the SF-36 explores areas such as physical health, pain, the ability to perform daily activities, vitality, emotional health, social functioning, and mental health.
Measured: 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)
a self-administered post-treatment questionnaire, comprised of eight items that evaluate the level of satisfaction regarding the care and quality of the service received and the level of fulfillment of the patient's expectations regarding the treatment administered. The total score of the questionnaire is 32 points, with higher values meaning higher satisfaction with the treatment received.
Measured: The test is administered after five weeks of treatment, and four weeks post-treatment.
Oxford Cognitive Screen (OCS)
A neuropsychological assessment tool that measures a person's global cognitive status, providing an analysis of key cognitive functions such as memory, executive functions, praxis, attention, language, and visuospatial exploration. Composed of various sub-tests, the OCS allows for the rapid and systematic identification of potential cognitive deficits and is particularly useful in patients with brain damage, such as those with stroke.
Measured: 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)
A test that measures short-term memory, specifically the ability to retain and recall sequences of numbers. During the test, the patient is asked to repeat a series of numbers read aloud by the examiner, starting with a short sequence and progressively increasing the length. The patient's performance is assessed based on the maximum number of digits they can correctly repeat in the same order as presented.
Measured: 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
A test that evaluates working memory, a cognitive function that allows the temporary storage and manipulation of information. In this test, the patient is asked to repeat a sequence of numbers read by the examiner, but in reverse order from how they were presented. The difficulty progressively increases with the addition of more digits in the sequence.
Measured: 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)
A neuropsychological test that evaluates basic executive functions, including abilities such as abstraction, verbal ideation, sensitivity to interference, motor planning, inhibitory control, and environmental dependence. It has a maximum total score of 18 points, divided into 6 sub-tests, each of which can assign up to 3 points. High scores indicate preserved executive functioning.
Measured: 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.
Symbol Digit Modalities Test
This test evaluates the visual information processing speed and attention; the number of correct answers in 90 seconds is registered (higher scores indicate better performance).
Measured: 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.
Hospital Anxiety and Depression Scale (HADS)
HADS is a self-report questionnaire commonly used to assess emotional distress in medical patients, specifically focusing on symptoms of anxiety and depression. It consists of 14 items, with 7 items dedicated to anxiety (HADS-A) and 7 to depression (HADS-D). Each item is rated on a 4-point Likert scale ranging from 0 to 3, reflecting the intensity or frequency of symptoms over the past week. The maximum score is 21 for each subscale, with higher scores indicating greater symptom severity. Scores from 0 to 7 are considered within the normal range, 8 to 10 suggest borderline abnormal levels, and 11 or above indicate clinically significant anxiety or depression.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start26 Apr 2018
- Primary completion29 Apr 2025
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Smania, MD, Clinical Professor, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968923
- Sponsor's protocol ID
- 1742CESC
- Status last verified
- Feb 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Home-Based Rehabilitation Program in Stroke Survivors Using the Euleria Home® Device: A Crossover Study.
- ClinicalTrials.gov ID
- NCT06968923
- Acronym / sponsor ID
- 1742CESC
- Conditions
- Stroke, Telemedicine, Rehabilitation, Telerehabilitation
- Keywords
- Stroke, telemedicine, telerehabilitation, motor, cognitive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | –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. |
| Group B | Experimental | Behavioral: TelerehabilitationThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in person treatmentThe 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. | Behavioural | – |
| TelerehabilitationThe 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. | Behavioural | Group B |
Primary outcome
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.
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.
14 secondary outcomes
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.
Symbol Digit Modalities Test
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.
Hospital Anxiety and Depression Scale (HADS)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in person treatment and Telerehabilitation in people with Stroke and Telemedicine, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Varalta (045 8124956, valentina.varalta@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.