StrokeNCT06928857
Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
A study testing EMG-based FES rehabilitation and Traditional rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 3 sites in Italy.
Trial summary
Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- EMG-based FES rehabilitation and Traditional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 3 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years or older
- Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
- Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
- Signed informed consent
Who cannot join
- Score at the Mini Mental State Examination (adjusted for age and schooling) < 24
- Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
- Major head trauma
- Cardio-respiratory or internal clinical instability
- State of pregnancy or lactation
- Severe spasticity (Ashworth > 3)
Show all 26Show fewer
- Skin integrity problems at the interface surface with the device
- Implanted electronic devices
- Epilepsy not medically controlled
- Severe peripheral neuropathy
- Recent interventions
- Thrombosis, thrombophlebitis
- Active stent carrier less than six months
- Severe forms of arteriosclerosis, arterial circulatory disorders
- Hypertension not treated
- Cardiac arrhythmias
- Hemorrhagic disorders (hemophilia)
- Severe forms of diabetes mellitus
- Known allergy to materials making up the device or its applied parts
- Cancer or tumour disease
- Acute arthritis
- Other neurological diseases other than stroke
- Progressive muscular dystrophy
- Abdominal or inguinal hernias
- Undiagnosed back pain
- Diseases of internal organs
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Policlinico San Martino
Genova, 16132
Fondazione Don Carlo Gnocchi Onlus
La Spezia, 19125
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, 20148
About this study
Official title: Pilot Study on the Effects Induced by an Electromyographic-controlled Functional Electrical Stimulator (FitFES) for Upper Limb Rehabilitation in Post-stroke Patients
Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.
Read the detailed description
FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.
All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.
Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.
- Conditions
- Stroke
- Being tested
- EMG-based FES rehabilitation, Traditional rehabilitation
- Keywords
- EMG-controlled Functional Electrical Stimulation, Stroke rehabilitation, Medical device
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG-based FES rehabilitationDevice
Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device.
Traditional rehabilitationOther
Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises.
| Study group | Role | What they receive |
|---|---|---|
| FES group | Experimental | Subjects will use the device as need-based support to perform task-oriented exercises Receives: Device: EMG-based FES rehabilitation |
| CON group | Active comparator | Subjects will perform task-oriented exercises without the support of the device Receives: Other: Traditional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The ARAT test assesses upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
Fugl-Meyer Upper Extremity scale (FM-UE)
The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor fu ENnction, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FM-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with a total maximum score: 66 points (higher scores, best clinical profile).
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
Box and Block test (BBT)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. The BBT goal is to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The score is determined by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Higher scores on the test indicate better gross manual dexterity
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire
EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. It measures the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is scored on a Likert scale of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
Secondary outcomes (4)
Surface Electromyography (EMGs)
Surface Electromyography (EMGs) is a non-invasive tool able to assess muscular electrical activity during the execution of active movements using electrodes applied on the skin surface. Muscular contraction amplitude will be recorded from 24 sensors placed on upper limbs (12 sensors/limb), during the execution of motor acts. Then, the difference between patient's and observed model's temporal dynamic of muscular contraction will be chosen as EMG outcome.
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
Body Kinematics
Kinematics of the upper limb and trunk will be recorded using a 9-camera optoelectronic system during 3D motor acts. The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute trunk, shoulder, elbow and wrist angles.
Data processing will provide measures of deviations from physiological movement.
Measured: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1)
Treatment Safety
Data related to the safety of the device will be collected:
- Number of adverse events
- Number of drop-out related to patient intolerance to the device
Measured: After 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)
Cost-effectiveness ratio
The costs of the two rehabilitation paths (with and without device), related to direct costs (maintenance device, consumables) and indirect costs will be collected (training of therapists on the device, costs related to the patient using the device). Procedures to be performed in a single treatment session will also be evaluated, in terms of time needed for preparation and dressing, and of trained personnel required during a session. An estimate of the working cycles that the device can perform in a year will also be considered.
Measured: At the end of 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start3 Mar 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia, Ospedale Policlinico San Martino
- Responsible party
- Sponsor
- Investigators
- Maurizio Ferrarin, PhD, Eng, Principal investigator, IRCCS Fondazione Don Carlo Gnocchi ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928857
- Sponsor's protocol ID
- RAISE-FITFES-RCT
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared data will comprise only IPD used in results publication. Data will be available upon reasonable request.
Publications
Villepinte C, Verma A, Dimeglio C, De Boissezon X, Gasq D. Responsiveness of kinematic and clinical measures of upper-limb motor function after stroke: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2021 Mar;64(2):101366. doi: 10.1016/j.rehab.2020.02.005. Epub 2020 Mar 7.
PubMed 32156646de los Reyes-Guzman A, Dimbwadyo-Terrer I, Trincado-Alonso F, Monasterio-Huelin F, Torricelli D, Gil-Agudo A. Quantitative assessment based on kinematic measures of functional impairments during upper extremity movements: A review. Clin Biomech (Bristol). 2014 Aug;29(7):719-27. doi: 10.1016/j.clinbiomech.2014.06.013. Epub 2014 Jun 26.
PubMed 25017296Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.
PubMed 23155178Tropea P, Monaco V, Coscia M, Posteraro F, Micera S. Effects of early and intensive neuro-rehabilitative treatment on muscle synergies in acute post-stroke patients: a pilot study. J Neuroeng Rehabil. 2013 Oct 5;10:103. doi: 10.1186/1743-0003-10-103.
PubMed 24093623Yang N, An Q, Kogami H, Yamakawa H, Tamura Y, Takahashi K, Kinomoto M, Yamasaki H, Itkonen M, Shibata-Alnajjar F, Shimoda S, Hattori N, Fujii T, Otomune H, Miyai I, Yamashita A, Asama H. Temporal Features of Muscle Synergies in Sit-to-Stand Motion Reflect the Motor Impairment of Post-Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2019 Oct;27(10):2118-2127. doi: 10.1109/TNSRE.2019.2939193. Epub 2019 Sep 4.
PubMed 31494552Overduin SA, d'Avella A, Roh J, Carmena JM, Bizzi E. Representation of Muscle Synergies in the Primate Brain. J Neurosci. 2015 Sep 16;35(37):12615-24. doi: 10.1523/JNEUROSCI.4302-14.2015.
PubMed 26377453Golicki D, Niewada M, Buczek J, Karlinska A, Kobayashi A, Janssen MF, Pickard AS. Validity of EQ-5D-5L in stroke. Qual Life Res. 2015 Apr;24(4):845-50. doi: 10.1007/s11136-014-0834-1. Epub 2014 Oct 28.
PubMed 25347978Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876.
PubMed 9341688Page SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Phys Ther. 2012 Jun;92(6):791-8. doi: 10.2522/ptj.20110009. Epub 2012 Jan 26.
PubMed 22282773Crow JL, Kwakkel G, Bussmann JB, Goos JA, Harmeling-van der Wel BC; Early Prediction of Functional Outcome After Stroke (EPOS) Investigators. Are the hierarchical properties of the Fugl-Meyer assessment scale the same in acute stroke and chronic stroke? Phys Ther. 2014 Jul;94(7):977-86. doi: 10.2522/ptj.20130170. Epub 2014 Mar 27.
PubMed 24677254Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.
PubMed 25880033van der Lee JH, Beckerman H, Lankhorst GJ, Bouter LM. The responsiveness of the Action Research Arm test and the Fugl-Meyer Assessment scale in chronic stroke patients. J Rehabil Med. 2001 Mar;33(3):110-3. doi: 10.1080/165019701750165916.
PubMed 11482350Van der Lee JH, De Groot V, Beckerman H, Wagenaar RC, Lankhorst GJ, Bouter LM. The intra- and interrater reliability of the action research arm test: a practical test of upper extremity function in patients with stroke. Arch Phys Med Rehabil. 2001 Jan;82(1):14-9. doi: 10.1053/apmr.2001.18668.
PubMed 11239280Burton Q, Lejeune T, Dehem S, Lebrun N, Ajana K, Edwards MG, Everard G. Performing a shortened version of the Action Research Arm Test in immersive virtual reality to assess post-stroke upper limb activity. J Neuroeng Rehabil. 2022 Dec 3;19(1):133. doi: 10.1186/s12984-022-01114-3.
PubMed 36463219Carpinella I, Mazzoleni P, Rabuffetti M, Thorsen R, Ferrarin M. Experimental protocol for the kinematic analysis of the hand: definition and repeatability. Gait Posture. 2006 Jun;23(4):445-54. doi: 10.1016/j.gaitpost.2005.05.001. Epub 2005 Jun 22.
PubMed 15978812
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects Induced by an Electromyographic-controlled Functional Electrical Stimulator (FitFES) for Upper Limb Rehabilitation in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06928857
- Acronym / sponsor ID
- RAISE-FITFES-RCT
- Conditions
- Stroke
- Keywords
- EMG-controlled Functional Electrical Stimulation, Stroke rehabilitation, Medical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Istituto Italiano di Tecnologia, Ospedale Policlinico San Martino
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Apr 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.
Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.
Detailed description
FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.
All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.
Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FES group | Experimental | Device: EMG-based FES rehabilitationSubjects will use the device as need-based support to perform task-oriented exercises |
| CON group | Active comparator | Other: Traditional rehabilitationSubjects will perform task-oriented exercises without the support of the device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
- Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
- Signed informed consent
Key exclusion criteria (26 listed)
- Score at the Mini Mental State Examination (adjusted for age and schooling) < 24
- Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
- Major head trauma
- Cardio-respiratory or internal clinical instability
- State of pregnancy or lactation
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 |
|---|---|---|
| EMG-based FES rehabilitationEach subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device. | Device | FES group |
| Traditional rehabilitationEach subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises. | Other | CON group |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
The ARAT test assesses upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.
Fugl-Meyer Upper Extremity scale (FM-UE)
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor fu ENnction, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FM-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with a total maximum score: 66 points (higher scores, best clinical profile).
Box and Block test (BBT)
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
The Box and Block Test (BBT) measures unilateral gross manual dexterity. The BBT goal is to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The score is determined by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Higher scores on the test indicate better gross manual dexterity
EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. It measures the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is scored on a Likert scale of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
4 secondary outcomes
Surface Electromyography (EMGs)
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)
Body Kinematics
Time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1)
Treatment Safety
Time frame: After 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)
Cost-effectiveness ratio
Time frame: At the end of 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 32156646Villepinte C, Verma A, Dimeglio C, De Boissezon X, Gasq D. Responsiveness of kinematic and clinical measures of upper-limb motor function after stroke: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2021 Mar;64(2):101366. doi: 10.1016/j.rehab.2020.02.005. Epub 2020 Mar 7.
- Background: PubMed 25017296de los Reyes-Guzman A, Dimbwadyo-Terrer I, Trincado-Alonso F, Monasterio-Huelin F, Torricelli D, Gil-Agudo A. Quantitative assessment based on kinematic measures of functional impairments during upper extremity movements: A review. Clin Biomech (Bristol). 2014 Aug;29(7):719-27. doi: 10.1016/j.clinbiomech.2014.06.013. Epub 2014 Jun 26.
- Background: PubMed 23155178Roh J, Rymer WZ, Perreault EJ, Yoo SB, Beer RF. Alterations in upper limb muscle synergy structure in chronic stroke survivors. J Neurophysiol. 2013 Feb;109(3):768-81. doi: 10.1152/jn.00670.2012. Epub 2012 Nov 14.
- Background: PubMed 24093623Tropea P, Monaco V, Coscia M, Posteraro F, Micera S. Effects of early and intensive neuro-rehabilitative treatment on muscle synergies in acute post-stroke patients: a pilot study. J Neuroeng Rehabil. 2013 Oct 5;10:103. doi: 10.1186/1743-0003-10-103.
- Background: PubMed 31494552Yang N, An Q, Kogami H, Yamakawa H, Tamura Y, Takahashi K, Kinomoto M, Yamasaki H, Itkonen M, Shibata-Alnajjar F, Shimoda S, Hattori N, Fujii T, Otomune H, Miyai I, Yamashita A, Asama H. Temporal Features of Muscle Synergies in Sit-to-Stand Motion Reflect the Motor Impairment of Post-Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2019 Oct;27(10):2118-2127. doi: 10.1109/TNSRE.2019.2939193. Epub 2019 Sep 4.
- Background: PubMed 26377453Overduin SA, d'Avella A, Roh J, Carmena JM, Bizzi E. Representation of Muscle Synergies in the Primate Brain. J Neurosci. 2015 Sep 16;35(37):12615-24. doi: 10.1523/JNEUROSCI.4302-14.2015.
- Background: PubMed 25347978Golicki D, Niewada M, Buczek J, Karlinska A, Kobayashi A, Janssen MF, Pickard AS. Validity of EQ-5D-5L in stroke. Qual Life Res. 2015 Apr;24(4):845-50. doi: 10.1007/s11136-014-0834-1. Epub 2014 Oct 28.
- Background: PubMed 9341688Dorman PJ, Waddell F, Slattery J, Dennis M, Sandercock P. Is the EuroQol a valid measure of health-related quality of life after stroke? Stroke. 1997 Oct;28(10):1876-82. doi: 10.1161/01.str.28.10.1876.
- Background: PubMed 22282773Page SJ, Fulk GD, Boyne P. Clinically important differences for the upper-extremity Fugl-Meyer Scale in people with minimal to moderate impairment due to chronic stroke. Phys Ther. 2012 Jun;92(6):791-8. doi: 10.2522/ptj.20110009. Epub 2012 Jan 26.
- Background: PubMed 24677254Crow JL, Kwakkel G, Bussmann JB, Goos JA, Harmeling-van der Wel BC; Early Prediction of Functional Outcome After Stroke (EPOS) Investigators. Are the hierarchical properties of the Fugl-Meyer assessment scale the same in acute stroke and chronic stroke? Phys Ther. 2014 Jul;94(7):977-86. doi: 10.2522/ptj.20130170. Epub 2014 Mar 27.
- Background: PubMed 25880033Alt Murphy M, Resteghini C, Feys P, Lamers I. An overview of systematic reviews on upper extremity outcome measures after stroke. BMC Neurol. 2015 Mar 11;15:29. doi: 10.1186/s12883-015-0292-6.
- Background: PubMed 11482350van der Lee JH, Beckerman H, Lankhorst GJ, Bouter LM. The responsiveness of the Action Research Arm test and the Fugl-Meyer Assessment scale in chronic stroke patients. J Rehabil Med. 2001 Mar;33(3):110-3. doi: 10.1080/165019701750165916.
- Individual participant dataSharing planned: Yes. Shared data will comprise only IPD used in results publication. Data will be available upon reasonable request.
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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. This study is not recruiting at the moment.
Maurizio Ferrarin, PhD, Eng principal investigator
IRCCS Fondazione Don Carlo Gnocchi ONLUS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG-based FES rehabilitation and Traditional rehabilitation in people with Stroke, run by Fondazione Don Carlo Gnocchi ETS at 3 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 26 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)). The study lists 4 primary outcomes in all. 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 NCT06928857, which also lists 31 linked publications.
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 9 Sep 2026.