AzTrials
AzTrials

StrokeStrokeHomeFit4NCT06978413

Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients

A study testing Integrated Treatment with Digital Tools and Home-Based Educational Program in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 13 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Integrated Treatment with Digital Tools and Home-Based Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
13 sitesItaly
Study dates
20 May 2025to 31 Jul 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.
  • Age greater than 18 years.
  • Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.
  • Ability to perform the Timed Up and Go Test.

Who cannot join

  • Unstable clinical conditions.
  • Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment<17.5).
  • Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.
  • Refusal to sign informed consent.

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Irene G Aprile, MD, PhD contact

+390633086553

iaprile@dongnocchi.it

Marco Germanotta, PhD contact

+390633086553

mgermanotta@dongnocchi.it

13 sites in 1 country

Italy13 sites, 13 recruiting
  • Fondazione Don Carlo Gnocchi, Centro Gala

    Acerenza

    Rocco Santarsiero

    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri

    Bari

    Pietro Fiore

    Not yet recruiting
  • IRCCS Ospedale Policlinico San Martino

    Genova

    Carlo Trompetto

    Not yet recruiting
  • COT, Cure Ortopediche Traumatologiche, Istituto Clinico Polispecialistico

    Messina

    Ennio Ferlazzo

    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente

    Milan

    Jorge Navarro

    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri

    Milan

    Christian Lunetta

    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri

    Montescano

    Cira Fundarò

    Not yet recruiting
  • IRCCS Fondazione Mondino

    Pavia

    Roberto De Icco

    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

    Rome

    Irene G Aprile, MD, PhD, +390633086500, iaprile@dongnocchi.it

    Recruiting
  • Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

    Salerno

    Irene G Aprile

    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

    Sant'Angelo dei Lombardi

    Tommaso Cibellis

    Not yet recruiting
  • IRCCS Istituti Clinici Scientifici Maugeri

    Telese Terme

    Laura Marcuccio

    Not yet recruiting
  • Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo

    Tricarico

    Massimo Tolve

    Not yet recruiting

Other trials in Italy

About this study

Official title: Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program.

The main question it aims to answer is:

Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.

Read the detailed description

The aim of the study is to evaluate the effectiveness of a home-based treatment based on rehabilitation technologies by comparing it with a traditional educational program at home.

Primary objective: Demonstration of the superiority of a home-based rehabilitation program with digital tools (home-based technological telerehabilitation) over a home-based educational program (home-based usual care) in patients with stroke outcomes in improving static and dynamic balance.

Secondary objectives:

  • Evaluation of the impact of the frequency of the intervention on recovery;
  • Evaluation of the acceptability of the intervention with digital tools for the patient, the caregiver, and the health care provider;
  • Evaluation of the usability of the intervention with digital tools for the patient and the caregiver;
  • Evaluation of the economic sustainability of the integrated rehabilitation intervention with digital tools for the patient, the payer, and society through the creation of a cost-effectiveness, cost-utility, and, for the health system, budget impact analysis model evaluation and prediction, and related sensitivity analyses.

The study is designed as a multicenter, multimodal, randomized, controlled, parallel group (1:1), blinded interventional trial. It will be conducted at multiple clinical centers participating in a national research initiative. Randomization will be centralized and stratified by clinical center, time since stroke, and age.

The sample size was determined using a 2-tailed, 2-sample t-test, assuming a power of 80%, a type I error t of 0.05, a mean difference of 2.7 units on the primary outcome (specifically, the change in the Berg Balance Scale, corresponding to the minimum detectable change in chronic stroke patients) and a common standard deviation of 5.37 points. With these assumptions, a sample size of 128 cases was estimated. Further, considering a dropout rate of 20%, the final estimated sample size required is 160 cases. The calculation was performed using G*Power software.

All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites. Data will be systematically collected using the REDCap (Research Electronic Data Capture) platform.

Conditions
Stroke
Being tested
Integrated Treatment with Digital Tools, Home-Based Educational Program
Keywords
rehabilitation, telerehabilitation, digital technologies, home-based
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Treatment with Digital ToolsOther

    Patients will undergo a 6-week remote telerehabilitation program. The recommended frequency of treatment is a minimum of 3 sessions per week, but patients may adjust the schedule in agreement with their assigned therapist. If a patient is unable to complete at least 18 sessions due to clinical reasons, they will be considered as a dropout.

    Moreover, one session per week will be conducted synchronously, with the therapist remotely supervising the patient's activities in real time, while the remaining sessions will be asynchronous, allowing the patient to complete the exercises independently.

  • Home-Based Educational ProgramOther

    Patients will be monitored over a six-week period through weekly phone calls to assess their progress and overall condition. Additionally, participants are required to maintain an activity diary to document their engagement with the prescribed activities.

Study groups in NCT06978413
Study groupRoleWhat they receive
Treatment with Digital ToolsExperimentalThe experimental treatment involves home-based telerehabilitation protocols utilizing digital tools. Patients will perform task-oriented activities aimed at improving balance through standing and/or seated exercises under both static and dynamic conditions. Exercise complexity will be progressively adapted and personalized based on the patient's performance, improvement trajectory, and instrumental feedback from the digital system. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.
Receives: Other: Integrated Treatment with Digital Tools
Educational ProgramActive comparatorPatients in the Control Group will follow a self-guided educational program supported by printed materials outlining daily living activities to be performed at home.
Receives: Other: Home-Based Educational Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the Berg Balance Scale (BBS)

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

Secondary outcomes (17)
  1. Fugl-Meyer Assessment for the upper extremities - motor function

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity motor function domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. It ranges from 0 (hemiplegia) to 66 (normal motor performance).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  2. Fugl-Meyer Assessment for the upper extremities - sensory function

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The upper extremity sensory function domain evaluates light touch on two surfaces of the arm, and position sense for upper limb joints. It ranges from 0 to 12 (normal sensory function).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  3. Fugl-Meyer Assessment for the lower extremities - motor function

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity motor function domain includes items assessing movement, coordination, and reflex action of the hip, knee, and ankle. It ranges from 0 (hemiplegia) to 34 (normal motor performance).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  4. Fugl-Meyer Assessment for the lower extremities - sensory function

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The lower extremity sensory function domain evaluates light touch on two surfaces of the leg, and position sense for lower limb joints. It ranges from 0 to 12 (normal sensory function).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  5. Modified Rivermead Motricity Index

    The Modified Rivermead Motricity Index (MRMI) is a clinical tool used to assess motor function and mobility in patients with neurological impairments. It consists of 8 items that evaluate motor control, balance, and mobility, with a total possible score of 40 points. Each item is scored on a 5-point ordinal scale (0-5), with higher scores indicating better function.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  6. Symbol Digit Modalities Test

    The Symbol Digit Modalities Test evaluates information processing speed. It consists of a simple task of replacing symbols with numbers. Using a reference key, the patient has 90 seconds to match a sequence of symbols with the correspondent numbers as rapidly as possible. Both written or oral administration can be used. For each correct answer, a point is assigned. The higher the score, the faster the information processing speed.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  7. Modified Barthel Index

    The modified Barthel Index for Activities of Daily Living is a validated ordinal scale which measures a person's ability to complete activities of daily living (ADL). Scores range from 0 (total dependence) to 100 (total independence).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  8. Modified Ashworth Scale

    The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0 to 4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch. The lower the score, the lower the spasticity. Upper and lower joints spasticity is assessed.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  9. Motricity Index for upper extremities

    The Motricity Index (MI) is an ordinal method of measuring limb strength. For upper extremity test, shoulder abduction, elbow flexion, pinch grip are considered. It ranges from 0 (worse) to 100 (normal strength).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  10. Motricity Index for lower extremities

    The Motricity Index (MI) is an ordinal method of measuring limb strength. For lower extremity test, hip flexion, knee extension, and ankle dorsiflexion are considered. It ranges from 0 (worse) to 100 (normal strength).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  11. Trunk control test

    The Trunk control test (TCT) measures four simple aspects of trunk movement. Total score range from 0 (minimum) to 100 (maximum, indicating better performance).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  12. Numerical Rating Scale for Pain

    The Numerical Rating Scale fo Pain (NRSP) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  13. Neuropathic Pain 4 Questions

    The Neuropathic Pain 4 Questions (DN4) is a validated clinician-administered screening tool for neuropathic pain. It ranges from 0 to 10; higher values means higher neuropathic pain probability.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  14. Functional Ambulation Classification Scale

    The Functional Ambulation Classification (FAC) Scale is a simple and widely used tool to assess a person's ability to walk (ambulate) independently after a neurological injury. It evaluates how much physical support a person needs while walking and helps clinicians classify their functional mobility. The FAC consists of six levels (0-5), ranging from non-functional ambulation to independent walking.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  15. Frontal Assessment Battery

    The Frontal Assessment Battery (FAB) is a clinical tool designed to assess frontal lobe functions, particularly executive functions, which are cognitive processes like problem-solving, decision-making, and impulse control. The FAB consists of six subtests, each scored from 0 to 3, with a maximum total score of 18 points. Higher scores indicate better frontal lobe function.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  16. World Health Organization disability assessment schedule 2.0 - WHODAS 2.0

    WHODAS 2.0 assesses the functioning and disability level in six domains (cognition, mobility, self-care, getting along, life activities, and participation in community activities) according to the International Classification of Functioning, Disability and Health (ICF). The summary scores for the WHODAS 2.0 will be obtained through 3 steps: 1) summing of item scores within each domain; 2) summing all six domain scores; 3) converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability and 100 = full disability).

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

  17. 5-level EQ-5D version (EQ-5D-5L)

    The 5-level EQ-5D version (EQ-5D-5L) is a validated tool to assess health-related quality of life. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0.

    Measured: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2025
  2. Study start20 May 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

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
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06978413
Sponsor's protocol ID
Fit4MedRobStroke@Home
Other IDs
PNC0000007
Acronym
StrokeHomeFit4
Status last verified
Apr 2025
First submitted
9 May 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) that underlie the results reported in the publication will be shared.

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Treatment with Digital Tools and Home-Based Educational Program in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 13 sites 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 4 inclusion and 4 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 30 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 13 sites 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 Irene G Aprile, MD, PhD (+390633086553, iaprile@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in the Berg Balance Scale (BBS) (time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period). 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 30 May 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in