“…A CPM device, a prime example of an electrically-powered orthopedic exerciser, prevents stiffness and stimulates the regeneration of joint tissues by providing continuous passive exercise to patients with musculoskeletal disorders [14]. Electrically-powered orthopedic exercisers with various added functions, including a knee CPM device controlled and monitored using a mobile phone application, and an upper extremity rehabilitation CPM device with added active exercise functions are currently being developed [15,16]. The objective of this study was to conduct a formative evaluation of Rebless Pro, a CPM device currently under development in Korea.…”
BACKGROUND
Errors while using medical devices, owing to flaws in the user interface design and implementation, can be a risk for users. Accordingly, increasing emphasis is being placed on usability evaluations by actual users in the design and development stages of medical devices to minimize the risk factors that may cause usage errors. Moreover, a usability evaluation is a mandatory requirement for medical device regulations in countries that follow the IEC 60601-1 standard.
OBJECTIVE
This study aimed to conduct a formative evaluation using focus group interviews (FGIs) and satisfaction surveys with healthcare professionals in the field of rehabilitation medicine to identify areas for improvement to enhance the safety and convenience of an electrically-powered orthopedic exerciser, a lower-extremity medical rehabilitation device, in the prototype stage.
METHODS
Quantitative and qualitative data were collected through formative evaluation conducted using FGIs and satisfaction surveys with participants; participants consisted of rehabilitation doctors (n=5) and physical therapists (n=5) with experience in using similar medical devices.
RESULTS
During the formative evaluation, the following three categories were derived to reduce exerciser usage errors: 1) product upgrades to ensure safety, 2) hardware and software improvements for convenience of use, and 3) improvement of the manual for better identifiability and understanding of the product and instructions.
CONCLUSIONS
Improvement areas to ensure safety, convenience of use, and clarity of instructions were identified through a formative evaluation based on FGIs and satisfaction surveys with healthcare professionals with experience in using similar medical devices. The factors derived from this formative evaluation are expected to contribute to the development of an improved electrically-powered orthopedic exerciser, and repeated formative and summative evaluations of the improved version will eventually lead to the development of a safe medical device.
“…A CPM device, a prime example of an electrically-powered orthopedic exerciser, prevents stiffness and stimulates the regeneration of joint tissues by providing continuous passive exercise to patients with musculoskeletal disorders [14]. Electrically-powered orthopedic exercisers with various added functions, including a knee CPM device controlled and monitored using a mobile phone application, and an upper extremity rehabilitation CPM device with added active exercise functions are currently being developed [15,16]. The objective of this study was to conduct a formative evaluation of Rebless Pro, a CPM device currently under development in Korea.…”
BACKGROUND
Errors while using medical devices, owing to flaws in the user interface design and implementation, can be a risk for users. Accordingly, increasing emphasis is being placed on usability evaluations by actual users in the design and development stages of medical devices to minimize the risk factors that may cause usage errors. Moreover, a usability evaluation is a mandatory requirement for medical device regulations in countries that follow the IEC 60601-1 standard.
OBJECTIVE
This study aimed to conduct a formative evaluation using focus group interviews (FGIs) and satisfaction surveys with healthcare professionals in the field of rehabilitation medicine to identify areas for improvement to enhance the safety and convenience of an electrically-powered orthopedic exerciser, a lower-extremity medical rehabilitation device, in the prototype stage.
METHODS
Quantitative and qualitative data were collected through formative evaluation conducted using FGIs and satisfaction surveys with participants; participants consisted of rehabilitation doctors (n=5) and physical therapists (n=5) with experience in using similar medical devices.
RESULTS
During the formative evaluation, the following three categories were derived to reduce exerciser usage errors: 1) product upgrades to ensure safety, 2) hardware and software improvements for convenience of use, and 3) improvement of the manual for better identifiability and understanding of the product and instructions.
CONCLUSIONS
Improvement areas to ensure safety, convenience of use, and clarity of instructions were identified through a formative evaluation based on FGIs and satisfaction surveys with healthcare professionals with experience in using similar medical devices. The factors derived from this formative evaluation are expected to contribute to the development of an improved electrically-powered orthopedic exerciser, and repeated formative and summative evaluations of the improved version will eventually lead to the development of a safe medical device.
“…Another way to improve the controlling performance of a CPM machine is through using a pneumatic artificial muscle (PAM) actuator as an alternative to an electric actuator brushless direct current motor (BLDCM) by using a Hybrid Neuro-PID control algorithm using the neural network as a control algorithm [8]. Issa et al (2019) developed a mobile phone application using App Inventor to control the CPM device instead of the main remote controller of a CPM machine [9]. This allowed for wireless connection to the CPM device, permitting simplified control and monitoring.…”
There is a lack of research in using electromyography (EMG) signals to control a continuous passive motion (CPM) machine. This study aimed to develop an interface instrument for digitalising EMG signals and controlling a CPM machine. Methods: The proposed device was designed with the following: (1) a signal processing unit which converted the EMGs from analogue to digital for the controller; (2) a personal computer which stored and displayed the EMG signals; (3) an LCD device to display the running angle of the CPM; and (4) a microcontroller unit to control the input/output signals and process the algorithm, driving the CPM. To validate the reliability of the proposed system, a total of 600 EMG trials were collected from 10 healthy subjects by using the proposed device via the Delsys® TringoTM EMG system and simultaneously using the Vicon® motion capture system. Result: This proposed device was able to digitalise and process EMG signals from eight channels of muscles, and the signals were able to drive a CPM. The validated results showed that the digitalised EMG signals by the proposed device were statistically similar to and correlated with the signals by the Vicon system with a median correlation coefficient of 0.81, with the 25% and 75% range being 0.56–0.92 with all pairs (300 pairs of EMG trials) (p < 0.001). Conclusions: This study confirmed that the developed device can digitalise EMG signals and drive a CPM as an applicable prototype that can work as an interface between EMG and CPM devices with high reliability.
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