Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients
NCT ID: NCT06928857
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
50 participants
INTERVENTIONAL
2025-03-03
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Functional Electrical Stimulation to Treat Critical Neuromyopathy After Severe Stroke: a Pilot Study.
NCT07130929
Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke
NCT02818608
BCI Driving FES and Hand Orthosis for Upper Limb Rehabilitation in Chronic Stroke
NCT06179745
Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
NCT00142792
Combined Behavioral Approaches With Functional Electrical Therapy in Stroke Rehabilitation
NCT01523925
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FES group
Subjects will use the device as need-based support to perform task-oriented exercises
EMG-based FES rehabilitation
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.
CON group
Subjects will perform task-oriented exercises without the support of the device
Traditional rehabilitation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EMG-based FES rehabilitation
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 rehabilitation
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istituto Italiano di Tecnologia
OTHER
Ospedale Policlinico San Martino
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maurizio Ferrarin, PhD, Eng
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi Onlus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale Policlinico San Martino
Genova, , Italy
Fondazione Don Carlo Gnocchi Onlus
La Spezia, , Italy
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
de 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.
Roh 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.
Tropea 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.
Yang 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.
Overduin 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.
Golicki 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.
Dorman 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.
Page 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.
Crow 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.
Alt 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.
van 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.
Van 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.
Burton 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.
Carpinella 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.
Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.
Chen HM, Chen CC, Hsueh IP, Huang SL, Hsieh CL. Test-retest reproducibility and smallest real difference of 5 hand function tests in patients with stroke. Neurorehabil Neural Repair. 2009 Jun;23(5):435-40. doi: 10.1177/1545968308331146. Epub 2009 Mar 4.
Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.
van der Lee JH, Roorda LD, Beckerman H, Lankhorst GJ, Bouter LM. Improving the Action Research Arm test: a unidimensional hierarchical scale. Clin Rehabil. 2002 Sep;16(6):646-53. doi: 10.1191/0269215502cr534oa.
Li L, Scott CA, Rothwell PM. Association of Younger vs Older Ages With Changes in Incidence of Stroke and Other Vascular Events, 2002-2018. JAMA. 2022 Aug 9;328(6):563-574. doi: 10.1001/jama.2022.12759.
Wafa HA, Wolfe CDA, Emmett E, Roth GA, Johnson CO, Wang Y. Burden of Stroke in Europe: Thirty-Year Projections of Incidence, Prevalence, Deaths, and Disability-Adjusted Life Years. Stroke. 2020 Aug;51(8):2418-2427. doi: 10.1161/STROKEAHA.120.029606. Epub 2020 Jul 10.
Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
Thorsen R, Cortesi M, Jonsdottir J, Carpinella I, Morelli D, Casiraghi A, Puglia M, Diverio M, Ferrarin M. Myoelectrically driven functional electrical stimulation may increase motor recovery of upper limb in poststroke subjects: a randomized controlled pilot study. J Rehabil Res Dev. 2013;50(6):785-94. doi: 10.1682/JRRD.2012.07.0123.
Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
Crepaldi M, Thorsen R, Jonsdottir J, Scarpetta S, De Michieli L, Salvo MD, Zini G, Laffranchi M, Ferrarin M. FITFES: A Wearable Myoelectrically Controlled Functional Electrical Stimulator Designed Using a User-Centered Approach. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2142-2152. doi: 10.1109/TNSRE.2021.3120293. Epub 2021 Oct 28.
Jonsdottir J, Thorsen R, Aprile I, Galeri S, Spannocchi G, Beghi E, Bianchi E, Montesano A, Ferrarin M. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach. PLoS One. 2017 Dec 4;12(12):e0188642. doi: 10.1371/journal.pone.0188642. eCollection 2017.
Perini G, Bertoni R, Thorsen R, Carpinella I, Lencioni T, Ferrarin M, Jonsdottir J. Sequentially applied myoelectrically controlled FES in a task-oriented approach and robotic therapy for the recovery of upper limb in post-stroke patients: A randomized controlled pilot study. Technol Health Care. 2021;29(3):419-429. doi: 10.3233/THC-202371.
Eraifej J, Clark W, France B, Desando S, Moore D. Effectiveness of upper limb functional electrical stimulation after stroke for the improvement of activities of daily living and motor function: a systematic review and meta-analysis. Syst Rev. 2017 Feb 28;6(1):40. doi: 10.1186/s13643-017-0435-5.
Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4.
Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed definitions and a shared vision for new standards in stroke recovery research: The Stroke Recovery and Rehabilitation Roundtable taskforce. Int J Stroke. 2017 Jul;12(5):444-450. doi: 10.1177/1747493017711816.
Raghavan P. Upper Limb Motor Impairment After Stroke. Phys Med Rehabil Clin N Am. 2015 Nov;26(4):599-610. doi: 10.1016/j.pmr.2015.06.008. Epub 2015 Aug 25.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RAISE-FITFES-RCT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.