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

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Healthy Health Care Professionals; Stroke

Treatments: Device: EMG-based FES device

Study type: Interventional

Funder types: Other

Identifiers

NCT06763874

RAISE-FITFES-US

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

One usability session

Experimental group

Description:

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

Treatment:

Device: EMG-based FES device