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| Name | Class |
|---|---|
| Istituto Italiano di Tecnologia | OTHER |
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Functional recovery of the upper limb after a cerebral stroke is one of the major critical issues in rehabilitation. The advent of innovative technologies can be helpful to rehabilitators and intervene where there is no other solution but a clear therapeutic indication. The use of functional electrostimulators can actively and functionally support movements, helping people affected by stroke to complete a motor gesture taking into account their residual capacities.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One usability session | Experimental | Subjects will use the device as need-based support to perform motor tasks related to activities of daily living |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMG-based FES device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| System Usability Scale (SUS) | The SUS assesses Usability and Acceptability of a device. The SUS consists of a 10 item questionnaire with five response options for respondents, from strongly agree to strongly disagree. | At the end of the single test session (the session is 60 minutes) |
| Unified Theory of Acceptance and Use of Technology (UTAUT) | A questionnaire asking how acceptable and easy to use the technological device is. The theoretical model of UTAUT suggests that the actual use of technology is determined by behavioural intention. The perceived likelihood of adopting the technology is dependent on the direct effect of four key constructs, namely performance expectancy, effort expectancy, social influence, and facilitating conditions. The UTAUT examines the acceptance of technology, determined by the effects of performance expectancy, effort expectancy, social influence and facilitating conditions. | At the end of the single test session (the session is 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Rehabilitation Motivation Scale (7-item SRMS) | Motivational impact of the rehabilitation approach used The 7-item SRMS was devised from the 28-item SRMS and inquires upon intrinsic and extrinsic motivation domains for rehabilitation. Scores range from 1 to 7 so the total score can range from 7-35 with higher scores indicating higher motivation. | At the end of the single test session (the session is 60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic data and professional background information | Age, gender, scholarity, professional background | At the start of the single test session (the session is 60 minutes) |
Stroke Inclusion Criteria:
Stroke Exclusion Criteria
Healthy health care professionals inclusion criteria:
Healthy health care professionals exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Ferrarin | IRCCS Fondazione Don Carlo Gnocchi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Fondazione Don Carlo Gnocchi Onlus | Milan | 20148 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20556766 | Background | 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. | |
| 27679565 | Background | 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. |
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Shared data will comprise only IPD used in results publication. Data will be available upon reasonable request.
Data will be available after publication with no end date
Request should be addressed to the principal investigator or the corresponding author of the publication.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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A single-session usability study: ten stroke patients and ten experienced healthcare workers will test the device to evaluate its design and operability.
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| Rating of Perceived Exertion/Borg 6-20 (RPE) | Perception of the overall and of the upper limb stress. The scale rates exertion from a scale of 6 (no exertion) to 20 (maximum effort). | At the end of the single test session (the session is 60 minutes) |
| Semi-structured interviews | Open-answer questionnaires related to the use of the FES device, its application in rehabilitation and the subjects perception of device usability | At the end of the single test session (the session is 60 minutes) |
| Report of adverse events | Organized reporting of adverse events occurring during the use of the device | At the end of the single test session (the session is 60 minutes) |
| 28934920 | Background | 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. |
| 23217359 | Background | 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. |
| 28503532 | Background | 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. |
| 33386831 | Background | 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. |
| 29200424 | Background | 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. |
| 32646325 | Background | 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. |
| 35943470 | Background | 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. |
| 35078916 | Background | 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. |
| 27145936 | Background | 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |