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

Not Applicable

Not yet recruiting

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.

Recruitment & Eligibility

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:

Healthy health care professionals exclusion criteria:

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
System Usability Scale (SUS)	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.
Unified Theory of Acceptance and Use of Technology (UTAUT)	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 Outcome Measures

Name	Time	Method
Stroke Rehabilitation Motivation Scale (7-item SRMS)	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.
Rating of Perceived Exertion/Borg 6-20 (RPE)	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).
Semi-structured interviews	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
Report of adverse events	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