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.
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.
13 sites in 1 country
Italy13 sites, 13 recruiting
- Not yet 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
- Recruiting
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Rome
Irene G Aprile, MD, PhD, +390633086500, iaprile@dongnocchi.it
- Not yet 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
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 group | Role | What they receive |
|---|---|---|
| Treatment with Digital Tools | Experimental | The 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 Program | Active comparator | Patients 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted18 May 2025
- Study start20 May 2025
- Primary completion1 May 2026 (estimated)
- Study completion31 Jul 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.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, IRCCS National Neurological Institute "C. Mondino" Foundation, Ospedale Policlinico San Martino, C.O.T. Cure Ortopediche Traumatologiche S.p.A., University of Pavia, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Campus Bio-Medico University
- Responsible party
- Sponsor
- Investigators
- Irene G Aprile, MD, PhD, Study director, IRCCS Fondazione Don Carlo GnocchiChristian Lunetta, Principal investigator, IRCCS Istituti Clinici Scientifici MaugeriRoberto De Icco, Principal investigator, IRCCS Fondazione MondinoCarlo Trompetto, Principal investigator, IRCCS Ospedale Policlinico San MartinoEnnio Ferlazzo, Principal investigator, COT Istituto Clinico PolispecialisticoSilvana Quaglini, Principal investigator, University of PaviaGiuseppe Turchetti, Principal investigator, Università Sant'Anna di PisaLeandro Pecchia, Principal investigator, Campus Bio-Medico University
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.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06978413
- Acronym / sponsor ID
- StrokeHomeFit4 / Fit4MedRobStroke@Home
- Conditions
- Stroke
- Keywords
- rehabilitation, telerehabilitation, digital technologies, home-based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, IRCCS National Neurological Institute "C. Mondino" Foundation, Ospedale Policlinico San Martino, C.O.T. Cure Ortopediche Traumatologiche S.p.A., University of Pavia, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna, Campus Bio-Medico University
- Study start
- 20 May 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 18 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with Digital Tools | Experimental | Other: Integrated Treatment with Digital ToolsThe 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. |
| Educational Program | Active comparator | Other: Home-Based Educational ProgramPatients in the Control Group will follow a self-guided educational program supported by printed materials outlining daily living activities to be performed at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Integrated Treatment with Digital ToolsPatients 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. | Other | Treatment with Digital Tools |
| Home-Based Educational ProgramPatients 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. | Other | Educational Program |
Primary outcome
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
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.
17 secondary outcomes
Fugl-Meyer Assessment for the upper extremities - motor function
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the upper extremities - sensory function
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the lower extremities - motor function
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Fugl-Meyer Assessment for the lower extremities - sensory function
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Rivermead Motricity Index
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Symbol Digit Modalities Test
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Barthel Index
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Modified Ashworth Scale
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Motricity Index for upper extremities
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Motricity Index for lower extremities
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Trunk control test
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Numerical Rating Scale for Pain
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Neuropathic Pain 4 Questions
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Functional Ambulation Classification Scale
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
Frontal Assessment Battery
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
World Health Organization disability assessment schedule 2.0 - WHODAS 2.0
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
5-level EQ-5D version (EQ-5D-5L)
Time frame: Baseline; within 7 days after the end of the 6-week observation/rehabilitation period
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 30 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the publication will be shared.
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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.
Irene G Aprile, MD, PhD study director
IRCCS Fondazione Don Carlo Gnocchi
Christian Lunetta principal investigator
IRCCS Istituti Clinici Scientifici Maugeri
Roberto De Icco principal investigator
IRCCS Fondazione Mondino
13 sites in 1 country: see every site and its status.
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.