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StrokeNCT06763874

Usability and Acceptability Study of a Functional Electro-stimulator Controlled by Electromyographic Signal (FitFES)

A study testing EMG-based FES device in people with Stroke and Healthy Health Care Professionals, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Stroke, Healthy Health Care Professionals
What is being tested?
EMG-based FES device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
14 Jan 2025to 25 Feb 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
  • Healthy volunteers accepted
  • Adult, Older adult

Stroke Inclusion Criteria:

  • Age equal to or greater than 18 years
  • Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks

Stroke Exclusion Criteria

  • Mini Mental State Examination (corrected for age and schooling) < 24
  • 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

Healthy health care professionals inclusion criteria:

  • Age equal to or greater than 18 years

Healthy health care professionals exclusion criteria:

  • Pregnancy
  • Skin integrity issues on the surface interfaced with the device
  • Implanted electronic devices

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Fondazione Don Carlo Gnocchi Onlus

    Milan, 20148

Other trials in Italy

About this study

Official title: Pilot Study of Usability and Acceptability for the Optimization of a Functional Electrical Stimulator Controlled by Electromyographic Signal for the Rehabilitation of the Upper Limb in Persons Post-stroke

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.

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 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.

Being tested
EMG-based FES device
Keywords
Stroke, Functional electrical stimulation, Feasibility, Usability, 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 deviceDevice

    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.

Study groups in NCT06763874
Study groupRoleWhat they receive
One usability sessionExperimentalSubjects will use the device as need-based support to perform motor tasks related to activities of daily living
Receives: Device: EMG-based FES device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At the end of the single test session (the session is 60 minutes)

  2. 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.

    Measured: At the end of the single test session (the session is 60 minutes)

Secondary outcomes (4)

  1. 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.

    Measured: At the end of the single test session (the session is 60 minutes)

  2. 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).

    Measured: At the end of the single test session (the session is 60 minutes)

  3. 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

    Measured: At the end of the single test session (the session is 60 minutes)

  4. Report of adverse events

    Organized reporting of adverse events occurring during the use of the device

    Measured: At the end of the single test session (the session is 60 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2025
  2. Study start14 Jan 2025
  3. Primary completion25 Feb 2025
  4. Study completion25 Feb 2025

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
A single-session usability study: ten stroke patients and ten experienced healthcare workers will test the device to evaluate its design and operability.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06763874
Sponsor's protocol ID
RAISE-FITFES-US
Status last verified
Feb 2025
First submitted
19 Dec 2024
Last updated
28 Feb 2025
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

  • 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.

    PubMed 20556766

  • 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.

    PubMed 27679565

  • 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.

    PubMed 28934920

  • 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.

    PubMed 23217359

  • 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.

    PubMed 28503532

  • 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.

    PubMed 33386831

  • 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.

    PubMed 29200424

  • 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.

    PubMed 32646325

  • 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.

    PubMed 35943470

  • 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.

    PubMed 35078916

  • 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.

    PubMed 27145936

Questions about this trial

What is this clinical trial studying?

A study testing EMG-based FES device in people with Stroke and Healthy Health Care Professionals, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

System Usability Scale (SUS) (time frame: At the end of the single test session (the session is 60 minutes)). The study lists 2 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 NCT06763874, which also lists 11 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 28 Feb 2025.

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