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

NCT06763874 | Completed DMC

• 1 other identifier: RAISE-FITFES-US
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Healthy Health Care Professionals

Keywords

Stroke; Functional electrical stimulation; Feasibility; Usability; Medical device

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (4)

• Stroke Rehabilitation Motivation Scale (7-item SRMS)

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

• Rating of Perceived Exertion/Borg 6-20 (RPE)

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

• Semi-structured interviews

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

• Report of adverse events

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

Other Outcomes (1)

• Demographic data and professional background information

  At the start of the single test session (the session is 60 minutes)

Study Arms (1)

One usability session

EXPERIMENTAL

Subjects will use the device as need-based support to perform motor tasks related to activities of daily living

Device: EMG-based FES device

Interventions

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.

One usability session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Age equal to or greater than 18 years
• Pregnancy
• Skin integrity issues on the surface interfaced with the device
• Implanted electronic devices

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto Italiano di Tecnologia: collaborator

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

Location

Related Publications (11)

• 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.

  PMID: 20556766 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.

  PMID: 27679565 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.

  PMID: 28934920 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.

  PMID: 23217359 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.

  PMID: 28503532 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.

  PMID: 33386831 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.

  PMID: 29200424 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.

  PMID: 32646325 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.

  PMID: 35943470 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.

  PMID: 35078916 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.

  PMID: 27145936 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maurizio Ferrarin

  IRCCS Fondazione Don Carlo Gnocchi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-session usability study: ten stroke patients and ten experienced healthcare workers will test the device to evaluate its design and operability.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 8, 2025
• Study Start: January 14, 2025
• Primary Completion: February 25, 2025
• Study Completion: February 25, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication with no end date
• Access Criteria: Request should be addressed to the principal investigator or the corresponding author of the publication.

Locations

IT (1)