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

February 27, 2025 updated by: Fondazione Don Carlo Gnocchi Onlus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20148
        • IRCCS Fondazione Don Carlo Gnocchi ONLUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: One usability session
Subjects will use the device as need-based support to perform motor tasks related to activities of daily living
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS)
Time Frame: At the end of the single test session (the session is 60 minutes)
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)
Time Frame: At the end of the single test session (the session is 60 minutes)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke Rehabilitation Motivation Scale (7-item SRMS)
Time Frame: At the end of the single test session (the session is 60 minutes)
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)
Rating of Perceived Exertion/Borg 6-20 (RPE)
Time Frame: At the end of the single test session (the session is 60 minutes)
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
Time Frame: At the end of the single test session (the session is 60 minutes)
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
Time Frame: At the end of the single test session (the session is 60 minutes)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data and professional background information
Time Frame: At the start of the single test session (the session is 60 minutes)
Age, gender, scholarity, professional background
At the start of the single test session (the session is 60 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Istituto Italiano di Tecnologia

Investigators

  • Principal Investigator: Maurizio Ferrarin, IRCCS Fondazione Don Carlo Gnocchi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Actual)

February 25, 2025

Study Completion (Actual)

February 25, 2025

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAISE-FITFES-US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Shared data will comprise only IPD used in results publication. Data will be available upon reasonable request.

IPD Sharing Time Frame

Data will be available after publication with no end date

IPD Sharing Access Criteria

Request should be addressed to the principal investigator or the corresponding author of the publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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