Usability and Acceptability Study of a Functional Electro-stimulator Controlled by Electromyographic Signal (FitFES)
NCT ID: NCT06763874
Last Updated: 2025-02-28
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
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COMPLETED
NA
20 participants
INTERVENTIONAL
2025-01-14
2025-02-25
Brief Summary
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Detailed Description
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This study aims to assess the usability, acceptability, and satisfaction of this device by post-stroke subjects and healthcare workers.
Ten post-stroke subjects and ten healthy health care workers will be recruited. Participants will take part in a single session where they are going to execute motor tasks of daily living with the support of the FitFES. At the end of session participants will fill out questionnaires.
Collected results will serve as input for further development of the FitFES device, based on the requests and opinions of participants, to obtain a final version of the device that will be used in a randomized controlled study.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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One usability session
Subjects will use the device as need-based support to perform motor tasks related to activities of daily living
EMG-based FES device
One session of one hour to execute task-oriented exercises with the upper limb while wearing the EMG-based FES device. Submission of questionnaires related to usability, acceptance and satisfaction of the device.
Interventions
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EMG-based FES device
One session of one hour to execute task-oriented exercises with the upper limb while wearing the EMG-based FES device. Submission of questionnaires related to usability, acceptance and satisfaction of the device.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
* Age equal to or greater than 18 years
Exclusion Criteria
* Clinical evidence of visuospatial disorders, ideomotor apraxia, behavioral disorders, neglect, severe visual and auditory sensory disorders that prevent the use of the device
* Major head trauma
* Cardio-respiratory or internal clinical instability
* Pregnancy
* Severe spasticity (Ashworth scale \> 3)
* Skin integrity issues on the surface interfaced with the device
* Implanted electronic devices
* Epilepsy
* Severe peripheral neuropathies
* Pregnancy
* Skin integrity issues on the surface interfaced with the device
* Implanted electronic devices
18 Years
ALL
Yes
Sponsors
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Istituto Italiano di Tecnologia
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Responsible Party
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Principal Investigators
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Maurizio Ferrarin
Role: PRINCIPAL_INVESTIGATOR
IRCCS Fondazione Don Carlo Gnocchi
Locations
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IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, , Italy
Countries
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References
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Doyle S, Bennett S, Fasoli SE, McKenna KT. Interventions for sensory impairment in the upper limb after stroke. Cochrane Database Syst Rev. 2010 Jun 16;2010(6):CD006331. doi: 10.1002/14651858.CD006331.pub2.
Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
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. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
Bovonsunthonchai S, Hiengkaew V, Vachalathiti R, Vongsirinavarat M, Tretriluxana J. Effect of speed on the upper and contralateral lower limb coordination during gait in individuals with stroke. Kaohsiung J Med Sci. 2012 Dec;28(12):667-72. doi: 10.1016/j.kjms.2012.04.036. Epub 2012 Jul 28.
Hwang YI, Yoon J. Changes in gait kinematics and muscle activity in stroke patients wearing various arm slings. J Exerc Rehabil. 2017 Apr 30;13(2):194-199. doi: 10.12965/jer.1734898.449. eCollection 2017 Apr.
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.
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.
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.
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.
Dmytriw AA, Dibas M, Phan K, Efendizade A, Ospel J, Schirmer C, Settecase F, Heran MKS, Kuhn AL, Puri AS, Menon BK, Sivakumar S, Mowla A, Vela-Duarte D, Linfante I, Dabus GC, Regenhardt RW, D'Amato S, Rosenthal JA, Zha A, Talukder N, Sheth SA, Hassan AE, Cooke DL, Leung LY, Malek AM, Voetsch B, Sehgal S, Wakhloo AK, Goyal M, Wu H, Cohen J, Ghozy S, Turkel-Parella D, Farooq Z, Vranic JE, Rabinov JD, Stapleton CJ, Minhas R, Velayudhan V, Chaudhry ZA, Xavier A, Bullrich MB, Pandey S, Sposato LA, Johnson SA, Gupta G, Khandelwal P, Ali L, Liebeskind DS, Farooqui M, Ortega-Gutierrez S, Nahab F, Jillella DV, Chen K, Aziz-Sultan MA, Abdalkader M, Kaliaev A, Nguyen TN, Haussen DC, Nogueira RG, Haq IU, Zaidat OO, Sanborn E, Leslie-Mazwi TM, Patel AB, Siegler JE, Tiwari A; North American Neurovascular COVID-19 (NAN-C) Consortium & Society of Vascular and Interventional Neurology (SVIN) Investigators. Acute ischaemic stroke associated with SARS-CoV-2 infection in North America. J Neurol Neurosurg Psychiatry. 2022 Apr;93(4):360-368. doi: 10.1136/jnnp-2021-328354. Epub 2022 Jan 25.
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.
Other Identifiers
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RAISE-FITFES-US
Identifier Type: -
Identifier Source: org_study_id
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