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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- System Usability Scale (SUS)
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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
- Stroke Rehabilitation Motivation Scale (7-item SRMS)(At the end of the single test session (the session is 60 minutes))
- Rating of Perceived Exertion/Borg 6-20 (RPE)(At the end of the single test session (the session is 60 minutes))
- Semi-structured interviews(At the end of the single test session (the session is 60 minutes))
- Report of adverse events(At the end of the single test session (the session is 60 minutes))