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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stroke Inclusion Criteria:
- •Age equal to or greater than 18 years
- •Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
排除标准
- •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
- •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
研究组 & 干预措施
One usability session
Subjects will use the device as need-based support to perform motor tasks related to activities of daily living
干预措施: EMG-based FES device (Device)
结局指标
主要结局
System Usability Scale (SUS)
时间窗: 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)
时间窗: 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.
次要结局
- 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))