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NCT Number: NCT06763874

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Healthy Health Care Professionals Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Istituto Italiano di Tecnologia

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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