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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
IRCCS Fondazione Don Carlo Gnocchi Onlus
Milan, Italy
System Usability Scale (SUS)
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.
Time frame: At the end of the single test session (the session is 60 minutes)
Unified Theory of Acceptance and Use of Technology (UTAUT)
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.
Time frame: At the end of the single test session (the session is 60 minutes)
Stroke Rehabilitation Motivation Scale (7-item SRMS)
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.
Time frame: At the end of the single test session (the session is 60 minutes)
Rating of Perceived Exertion/Borg 6-20 (RPE)
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).
Time frame: At the end of the single test session (the session is 60 minutes)
Semi-structured interviews
Open-answer questionnaires related to the use of the FES device, its application in rehabilitation and the subjects perception of device usability
Time frame: At the end of the single test session (the session is 60 minutes)
Report of adverse events
Organized reporting of adverse events occurring during the use of the device
Time frame: At the end of the single test session (the session is 60 minutes)
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