Clinical trial NCT06763874: Usability and Acceptability Study of a Functional Electro-stimulator Controlled by Electromyographic Signal (FitFES)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Healthy Health Care Professionals
Keywords: Stroke
Functional electrical stimulation
Feasibility
Usability
Medical device
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: Istituto Italiano di Tecnologia
First posted: 2025-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: At the end of the single test session (the session is 60 minutes)
measure: Unified Theory of Acceptance and Use of Technology (UTAUT)
timeFrame: At the end of the single test session (the session is 60 minutes)
Secondary outcomes:
measure: Stroke Rehabilitation Motivation Scale (7-item SRMS)
timeFrame: At the end of the single test session (the session is 60 minutes)
measure: Rating of Perceived Exertion/Borg 6-20 (RPE)
timeFrame: At the end of the single test session (the session is 60 minutes)
measure: Semi-structured interviews
timeFrame: At the end of the single test session (the session is 60 minutes)
measure: Report of adverse events
timeFrame: At the end of the single test session (the session is 60 minutes)
Other outcomes:
measure: Demographic data and professional background information
timeFrame: At the start of the single test session (the session is 60 minutes)
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi Onlus
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi
name: Maurizio Ferrarin
role: PRINCIPAL_INVESTIGATOR
References:
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