StrokeStrokeFit4NCT06547827
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
A study testing robotic rehabilitation and traditional rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 27 sites in Italy.
Trial summary
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- robotic rehabilitation and traditional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 27 sitesItaly
- Study dates
- 12 Aug 2024to 30 Nov 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
- First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;
- Age 18 years and over;
- Time since the event equal to or less than 6 months;
- Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45);
- Clinical stability allowing transfer to the gym and execution of the planned treatments.
Who cannot join
- Clinical instability;
- Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment <10);
- Rigidity or hypertonia (Modified Ashworth Scale > 3) in the plegic/paretic limb;
- Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
- Pregnant women;
- Refusal to sign the informed consent.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
Italy27 sites, 27 recruiting
- Recruiting
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza
Rocco Santarsiero
- Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Bari
Pietro Fiore
- Recruiting
Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
Bergamo
Silvia Galeri
- Recruiting
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania
Michele Vecchio
- Recruiting
Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro)
Catanzaro
Antonio Ammendolia
- Recruiting
Istituto S. Anna di Ezio Pugliese s.r.l.
Crotone
Maria Elena Pugliese
- Recruiting
Università di Foggia (Azienda Ospedaliero-Universitaria "Policlinico Riuniti" - Foggia)
Foggia
Andrea Santamato
- Recruiting
IRCCS Ospedale Policlinico San Martino,
Genova
Trompetto Carlo
- Recruiting
IRCCS Centro Neurolesi "Bonino Pulejo"
Messina
Rocco Salvatore Calabrò
- Recruiting
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan
Jorge Navarro
- Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Milan
Christian Lunetta
- Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Montescano
Cira Fundarò
- Recruiting
Università degli Studi di Padova (Azienda Ospedale Università di Padova)
Padova
Stefano Masiero
- Recruiting
IRCCS Fondazione Mondino
Pavia
Roberto De Icco
- Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Pavia
Antonio Nardone
- Recruiting
Università di Pisa (A.O.U. Pisana)
Pisa
Carmelo Chisari
- Recruiting
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma
Irene G Aprile, MD, PhD, +390633086500, iaprile@dongnocchi.it
- Recruiting
IRCCS San Raffaele Roma s.r.l.
Roma
Sanaz Pournajaf
- Recruiting
Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.)
Rozzano
Alessio Baricich
- Recruiting
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno
Domiziano Tarantino
- Recruiting
Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona)
Salerno
Alessia Bramanti (UNISA) Marianna Amboni (AOU Ruggi)
- Recruiting
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi
Tommaso Cibellis
- Recruiting
Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno
Sterzing
Luca Sebastianelli
- Recruiting
IRCCS Istituti Clinici Scientifici Maugeri
Telese Terme
Laura Marcuccio
- Recruiting
APSS Trento
Trento
Jacopo Bonavita
- Recruiting
Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
Tricarico
Massimo Tolve
- Recruiting
San Camillo IRCCS s.r.l.
Venezia
Pawel Kiper
About this study
Official title: Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.
This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.
Read the detailed description
The aim of this study is to evaluate, in a pragmatic trial on a large sample of patients who have experienced a stroke within the six months prior to enrollment, the effectiveness of a multimodal treatment using robotics and advanced technologies compared to traditional multimodal treatment, in the recovery of activities of daily living.
Primary Objective: To demonstrate, in a population of subacute stroke patients, the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitative treatment in the recovery of activities of daily living.
Secondary Objectives:
- To demonstrate the superiority of rehabilitative treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the recovery of activities of daily living, should non-inferiority be demonstrated;
- To compare the improvements between two groups in all targeted domains (upper limb sensorimotor abilities; lower limb sensorimotor abilities and gait; balance; cognitive abilities), in accordance with the International Classification of Functioning, Disability, and Health (ICF);
- To analyze the neurophysiological parameters and factors involved in neuroplasticity processes;
- To compare the time pattern of manual dexterity and walking performance recovery in the two groups;
- To assess the effects of the rehabilitation treatment in terms of daily life activities and quality of life through medium-term follow-up;
- To evaluate the acceptability and usability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, their family, and the healthcare practitioner;
- To create a predictive model capable of forecasting the effectiveness of robotic and technological treatment in subjects after a stroke, based on a detailed description of the patient at baseline (using demographic data and clinical picture at admission);
- To assess the economic sustainability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, payer, and society, through the creation of a model for the assessment and prediction of cost-effectiveness, cost-utility, and, for the healthcare system, a Budget Impact Analysis, and related sensitivity analyses.
The study employs a multicenter, multimodal, randomized, controlled, parallel-group (1:1) interventional design with blinded assessors, following a pragmatic approach. It will be conducted across multiple clinical centers involved in a national research initiative, encompassing both outpatient and inpatient settings. Randomization will be centralized and stratified by clinical center, latency, and clinical setting (inpatients or outpatients).
The sample size (596 patients) was determined considering the following, with respect to the primary outcome (the change in the modified Barthel Index): (a) the non-inferiority of robotic treatment compared to traditional treatment; (b) a power of 80%; (c) a non-inferiority margin of 5 points; (d) a bilateral 95% confidence interval; (e) a standard deviation of the primary outcome of 20 points. Considering these parameters, a sample size of 506 patients (253 per group) is obtained. Additionally, considering a dropout rate of 15%, a total sample size of 596 patients is obtained. The same sample size is sufficient to also demonstrate the potential superiority of robotic treatment. In fact, considering a significance level of 5%, a power of 80%, a minimal clinically important difference of the scale of 9.25 points, a standard deviation of 20 points, and a dropout rate of 15%, a total of 178 patients are required for demonstrating superiority.
The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio. In both groups, patients will undergo comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities.
The primary outcome is to demonstrate non-inferiority in activities of daily living as measured by the modified Barthel Index. Should non-inferiority be established, the study will then evaluate the potential superiority of RADTs in activities of daily living.
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
- robotic rehabilitation, traditional rehabilitation
- Keywords
- rehabilitation, robotics
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic rehabilitationOther
Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity.
Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency:
- 5 times a week for 5 weeks, for inpatients;
- 3 times a week for 8.3 weeks, for outpatients.
traditional rehabilitationOther
A physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres.
Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency:
- 5 times a week for 5 weeks, for inpatients;
- 3 times a week for 8.3 weeks, for outpatients.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment with Robotic & Technological Devices (RADTs) | Experimental | This intervention employs various RADTs to target the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities. For upper limb sensorimotor function, we will use planar end-effector robots, exoskeletons, or electromechanical systems for shoulder, elbow, and wrist rehabilitation; end-effector robots or exoskeletons for hand rehabilitation; and sensor-based devices for comprehensive upper limb treatment. For lower limb sensorimotor function, we will utilize end-effector robots or exoskeletons and treadmills with body-weight support systems. Balance training will involve stabilometric platforms and sensor-based systems. Cognitive functions will be addressed using digital systems, sensor-based devices, and virtual reality programs. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications. Receives: Other: robotic rehabilitation |
| Traditional Treatment | Active comparator | In the control group, subjects will undergo a standard traditional rehabilitation program without the use of RADTs, focusing on the following domains:a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities, using traditional methods of physiotherapy and cognitive rehabilitation. Receives: Other: traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the 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 24 hours from the 25th rehabilitation session
Secondary outcomes (24)
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
Berg Balance Scale
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 scale designed to measure balance of the older adult in a clinical setting. It ranges from 0 to 56. A higher score indicates better balance.
Measured: baseline; within 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
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 24 hours from the 25th rehabilitation session
Action Research Arm test
The Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity and functioning). The 19 items comprising the ARAT are scored using a 4 point ordinal scale. Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: baseline; within 24 hours from the 25th rehabilitation session
2 Minute Walk Test
The 2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity. The person is encouraged to walk as fast as they can, safely, without assistance for two minutes and the distance is measured.
Measured: baseline; within 24 hours from the 25th rehabilitation session
5-level EQ-5D
The 5-level EQ-5D (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 24 hours from the 25th rehabilitation session
Brain Symmetry Index
The Brain Symmetry Index (BSI) is a quantitative electroencephalographic (qEEG) measure used to assess the degree of symmetry in brain activity between the two hemispheres. It is defined as the mean absolute difference in spectral power of the EEG signals from homologous channels pairs on the left and right hemispheres, in the frequency range from 1 to 25 Hz. A higher BSI value indicates greater asymmetry, which is often associated with poorer clinical outcomes in stroke patients.
Measured: baseline; within 24 hours from the 25th rehabilitation session
Delta/Alpha Ratio
The Delta/Alpha Ratio (DAR) is a quantitative electroencephalographic (qEEG) measure used to assess the balance between slow-wave (delta) and fast-wave (alpha) brain activity. It is calculated by dividing the power of delta waves (0.5-4 Hz) by the power of alpha waves (8-12 Hz). The DAR is particularly useful in evaluating brain function in stroke patients, as an increased DAR is often associated with greater brain dysfunction and poorer clinical outcomes.
Measured: baseline; within 24 hours from the 25th rehabilitation session
Change in serum concentration of Glial Fibrillary Acidic Protein (GFAP)
Serum GFAP Concentration will be evaluated by "Ella" automated Immunoassay System method.
Measured: baseline; within 24 hours from the 25th rehabilitation session
Serum concentration of Neurofilament light (NfL)
Serum NfL Concentration will be evaluated by "Ella" automated Immunoassay System method.
Measured: baseline; within 24 hours from the 25th rehabilitation session
Serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Serum BDNF Concentration will be evaluated by "Ella" automated Immunoassay System method.
Measured: baseline; within 24 hours from the 25th rehabilitation session
10 Meter Walk Test
The 10 Meter Walk Test is a performance measure used to assess walking or gait speed in meters per second over a distance of 10 meters
Measured: baseline; within 24 hours from: the 5th rehabilitation session; the 10th rehabilitation session; the 15th rehabilitation session; the 20th rehabilitation session; the 25th rehabilitation session
Box and block test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. The individual is instructed to move as many blocks as possible, one at a time, from one compartment to the other of a test box with 150 blocks and a partition in the middle. The number of blocks transferred in 60 seconds is recorded. Both the affected and the not affected side are measured.
Measured: baseline; within 24 hours from: the 5th rehabilitation session; the 10th rehabilitation session; the 15th rehabilitation session; the 20th rehabilitation session; the 25th rehabilitation session
modified Barthel Index (follow-up)
The 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: 1 month after the end of the treatment; 2 months after the end of the treatment; 3 months after the end of the treatment; 4 months after the end of the treatment; 5 months after the end of the treatment; 6 months after the end of the treatment;
EQ-5D-5L (follow-up)
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: 1 month after the end of the treatment; 2 months after the end of the treatment; 3 months after the end of the treatment; 4 months after the end of the treatment; 5 months after the end of the treatment; 6 months after the end of the treatment;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start12 Aug 2024
- Primary completionNov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 596 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, University of Pavia, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Sponsor
- Investigators
- Irene G Aprile, Study director, IRCCS Fondazione Don Carlo GnocchiIrene G Aprile, Principal investigator, 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 MartinoSilvana Quaglini, Principal investigator, University of PaviaGiuseppe Turchetti, Principal investigator, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547827
- Sponsor's protocol ID
- FIT4MedRobStroke
- Other IDs
- PNC0000007
- Acronym
- StrokeFit4
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2024
- Last updated
- 24 Jul 2026
- 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.
Publications
Aprile IG, Germanotta M, Fasano A, Siotto M, Mauro MC, Pavan A, Nicora G, Sgandurra G, Malovini A, Oreni L, Dubbini N, Parimbelli E, Comande G, Lunetta C, Fiore P, De Icco R, Trompetto C, Trieste L, Turchetti G, Quaglini S, Messa C; STROKEFIT4 Study Group. Rehabilitation with and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: A Study Protocol for a Multicentre Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-Organisational Sustainability of RADTs from Subacute to Chronic Phase (STROKEFIT4). J Clin Med. 2025 Apr 15;14(8):2692. doi: 10.3390/jcm14082692.
PubMed 40283522
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase
- ClinicalTrials.gov ID
- NCT06547827
- Acronym / sponsor ID
- StrokeFit4 / FIT4MedRobStroke
- Conditions
- Stroke
- Keywords
- rehabilitation, robotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 596 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, University of Pavia, Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 9 Aug 2024 (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.
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes.
This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.
Detailed description
The aim of this study is to evaluate, in a pragmatic trial on a large sample of patients who have experienced a stroke within the six months prior to enrollment, the effectiveness of a multimodal treatment using robotics and advanced technologies compared to traditional multimodal treatment, in the recovery of activities of daily living.
Primary Objective: To demonstrate, in a population of subacute stroke patients, the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitative treatment in the recovery of activities of daily living.
Secondary Objectives:
- To demonstrate the superiority of rehabilitative treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the recovery of activities of daily living, should non-inferiority be demonstrated;
- To compare the improvements between two groups in all targeted domains (upper limb sensorimotor abilities; lower limb sensorimotor abilities and gait; balance; cognitive abilities), in accordance with the International Classification of Functioning, Disability, and Health (ICF);
- To analyze the neurophysiological parameters and factors involved in neuroplasticity processes;
- To compare the time pattern of manual dexterity and walking performance recovery in the two groups;
- To assess the effects of the rehabilitation treatment in terms of daily life activities and quality of life through medium-term follow-up;
- To evaluate the acceptability and usability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, their family, and the healthcare practitioner;
- To create a predictive model capable of forecasting the effectiveness of robotic and technological treatment in subjects after a stroke, based on a detailed description of the patient at baseline (using demographic data and clinical picture at admission);
- To assess the economic sustainability of the rehabilitative treatment integrated with robotic and/or technological devices for the patient, payer, and society, through the creation of a model for the assessment and prediction of cost-effectiveness, cost-utility, and, for the healthcare system, a Budget Impact Analysis, and related sensitivity analyses.
The study employs a multicenter, multimodal, randomized, controlled, parallel-group (1:1) interventional design with blinded assessors, following a pragmatic approach. It will be conducted across multiple clinical centers involved in a national research initiative, encompassing both outpatient and inpatient settings. Randomization will be centralized and stratified by clinical center, latency, and clinical setting (inpatients or outpatients).
The sample size (596 patients) was determined considering the following, with respect to the primary outcome (the change in the modified Barthel Index): (a) the non-inferiority of robotic treatment compared to traditional treatment; (b) a power of 80%; (c) a non-inferiority margin of 5 points; (d) a bilateral 95% confidence interval; (e) a standard deviation of the primary outcome of 20 points. Considering these parameters, a sample size of 506 patients (253 per group) is obtained. Additionally, considering a dropout rate of 15%, a total sample size of 596 patients is obtained. The same sample size is sufficient to also demonstrate the potential superiority of robotic treatment. In fact, considering a significance level of 5%, a power of 80%, a minimal clinically important difference of the scale of 9.25 points, a standard deviation of 20 points, and a dropout rate of 15%, a total of 178 patients are required for demonstrating superiority.
The experimental group will receive rehabilitation using RADTs within a new organizational model, where two physical therapists supervise four to six patients. In the control group, patients will undergo individual traditional rehabilitation, maintaining a 1:1 patient-to-therapist ratio. In both groups, patients will undergo comprehensive rehabilitation treatment, targeting the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; d) cognitive abilities.
The primary outcome is to demonstrate non-inferiority in activities of daily living as measured by the modified Barthel Index. Should non-inferiority be established, the study will then evaluate the potential superiority of RADTs in activities of daily living.
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 |
|---|---|---|
| Integrated Treatment with Robotic & Technological Devices (RADTs) | Experimental | Other: robotic rehabilitationThis intervention employs various RADTs to target the following domains: a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities. For upper limb sensorimotor function, we will use planar end-effector robots, exoskeletons, or electromechanical systems for shoulder, elbow, and wrist rehabilitation; end-effector robots or exoskeletons for hand rehabilitation; and sensor-based devices for comprehensive upper limb treatment. For lower limb sensorimotor function, we will utilize end-effector robots or exoskeletons and treadmills with body-weight support systems. Balance training will involve stabilometric platforms and sensor-based systems. Cognitive functions will be addressed using digital systems, sensor-based devices, and virtual reality programs. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications. |
| Traditional Treatment | Active comparator | Other: traditional rehabilitationIn the control group, subjects will undergo a standard traditional rehabilitation program without the use of RADTs, focusing on the following domains:a) upper limb sensorimotor abilities; b) lower limb sensorimotor abilities and gait; c) balance; and d) cognitive abilities, using traditional methods of physiotherapy and cognitive rehabilitation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;
- Age 18 years and over;
- Time since the event equal to or less than 6 months;
- Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45);
- Clinical stability allowing transfer to the gym and execution of the planned treatments.
Key exclusion criteria (6 listed)
- Clinical instability;
- Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment <10);
- Rigidity or hypertonia (Modified Ashworth Scale > 3) in the plegic/paretic limb;
- Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
- Pregnant women;
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 |
|---|---|---|
| robotic rehabilitationTreatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients. | Other | Integrated Treatment with Robotic & Technological Devices (RADTs) |
| traditional rehabilitationA physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients. | Other | Traditional Treatment |
Primary outcome
Change from baseline in the modified Barthel Index
Time frame: baseline; within 24 hours from the 25th rehabilitation session
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).
24 secondary outcomes
Fugl-Meyer Assessment for the upper extremities - motor function
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Fugl-Meyer Assessment for the upper extremities - sensory function
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Fugl-Meyer Assessment for the lower extremities - motor function
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Fugl-Meyer Assessment for the lower extremities - sensory function
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Berg Balance Scale
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Symbol Digit Modalities Test
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Modified Ashworth Scale
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Motricity Index for upper extremities
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Motricity Index for lower extremities
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Trunk control test
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Numerical Rating Scale for Pain
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Neuropathic Pain 4 Questions
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Action Research Arm test
Time frame: baseline; within 24 hours from the 25th rehabilitation session
2 Minute Walk Test
Time frame: baseline; within 24 hours from the 25th rehabilitation session
5-level EQ-5D
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Brain Symmetry Index
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Delta/Alpha Ratio
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Change in serum concentration of Glial Fibrillary Acidic Protein (GFAP)
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Serum concentration of Neurofilament light (NfL)
Time frame: baseline; within 24 hours from the 25th rehabilitation session
Serum concentration of Brain Derived Neurotrophic Factor (BDNF)
Time frame: baseline; within 24 hours from the 25th rehabilitation session
10 Meter Walk Test
Time frame: baseline; within 24 hours from: the 5th rehabilitation session; the 10th rehabilitation session; the 15th rehabilitation session; the 20th rehabilitation session; the 25th rehabilitation session
Box and block test
Time frame: baseline; within 24 hours from: the 5th rehabilitation session; the 10th rehabilitation session; the 15th rehabilitation session; the 20th rehabilitation session; the 25th rehabilitation session
modified Barthel Index (follow-up)
Time frame: 1 month after the end of the treatment; 2 months after the end of the treatment; 3 months after the end of the treatment; 4 months after the end of the treatment; 5 months after the end of the treatment; 6 months after the end of the treatment;
EQ-5D-5L (follow-up)
Time frame: 1 month after the end of the treatment; 2 months after the end of the treatment; 3 months after the end of the treatment; 4 months after the end of the treatment; 5 months after the end of the treatment; 6 months after the end of the 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 24 Jul 2026.
- Derived from this study: PubMed 40283522Aprile IG, Germanotta M, Fasano A, Siotto M, Mauro MC, Pavan A, Nicora G, Sgandurra G, Malovini A, Oreni L, Dubbini N, Parimbelli E, Comande G, Lunetta C, Fiore P, De Icco R, Trompetto C, Trieste L, Turchetti G, Quaglini S, Messa C; STROKEFIT4 Study Group. Rehabilitation with and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: A Study Protocol for a Multicentre Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-Organisational Sustainability of RADTs from Subacute to Chronic Phase (STROKEFIT4). J Clin Med. 2025 Apr 15;14(8):2692. doi: 10.3390/jcm14082692.
- 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 study director
IRCCS Fondazione Don Carlo Gnocchi
Irene G Aprile principal investigator
IRCCS Fondazione Don Carlo Gnocchi
Christian Lunetta principal investigator
IRCCS Istituti Clinici Scientifici Maugeri
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic rehabilitation and traditional rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 27 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 5 inclusion and 6 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 modified Barthel Index (time frame: baseline; within 24 hours from the 25th rehabilitation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547827, which also lists 1 linked publication.
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 24 Jul 2026.