# A Novel Soft Robotic Exoskeleton System for Hand Rehabilitation and Assistance Purposes
## 3 Results and Discussion
### Experimental Procedure and Validation
Towards this direction, a protocol has been developed to compare the SEG device with the standard of care; the protocol was evaluated by the Greek National Organization for Medicines and the Greek National Ethics Committee and received the green light to proceed to clinical trials classifying the device as Category IIa (moderate danger) due to the active motion of the SEG and the existence of electric power in the device. In order to obtain additional feedback on the usability and efficiency of the developed device (prior to the completion of the official clinical trials), a preliminary evaluation study took place with 30 participants. More specifically, in this study, we used 25 healthy participants aged over 25 years (14 male and 11 female) as a control group, and five patients with limited functionality of their hand recruited following the inclusion criteria described in Table 2. These 30 participants underwent the same experimental procedure and, at the end, answered a questionnaire of 14 questions with a 1-strongly disagree to 5-strongly agree Likert scale in order to document the opinions of the control group and the patients, concerning their user experience of the utilization of the SEG. In addition, five of the healthy people from the control group involved in our experiment were professional experts from the rehabilitation domain who responded, apart from the first questionnaire, to an additional one (Likert scale-based) consisting of five dedicated questions more relevant to the usability, the efficiency, and the applicability of the developed device, as described in Table 2.  
The questions of the first questionnaire evaluated the ease to use and the ease of carrying the device as well as the user-friendly graphical environment, ergonomics, functionality, and safety. The questions of the second questionnaire addressed technical issues and appealed to the operators of the device. These questionnaires were anonymously handed out and answered by all the participants. Regarding the experimental procedure, participants experienced a short session of 10 min with the SEG device exercising movements based on the Action Research Arm Test (ARAT) protocol [36] before answering the questionnaires. \begin{table}
\begin{tabular}{c c} \hline \hline
**Description** & **Patient Characteristics** \\ \hline Age & \textgreater{}25 \\ Gender & Male and female \\ Disabled limb & Left or right hand \\ Rehabilitation stage & Partial hypoxia \\ Disability medical condition & Monoplegia and hemiplegia \\ Pathological condition & Cerebrovascular accident \\ Level of disability & 1–3 (Ashworth scale) \\ \hline \hline \end{tabular}
\end{table} 
Table 2: Profile of the participants for the conducted clinical trials. In detail, four different exercises were performed, namely finger exercise and holding of objects of daily living (cup, pipe, and box), as illustrated in Figure 9. It is worth mentioning that all the examined movements were captured with the control glove and conducted from the SEG with robotic assistance enabled. After the use of the SEG device, the participants answered the questionnaires. Tables 3 and 4 list the participants' answers coupled with the questions of the two questionnaires, respectively. Figure 9: Indicative images of hand movements with the SEG and control glove. **(a)** Finger exercises; Holding exercises of **(b)** cup; **(c)** pipe; **(d)** box. According to the answers to the first questionnaires, the majority of all participants, i.e., 60% (agree or strongly agree), were familiar with rehabilitation technologies, and 100% of the control group and 80% of the patients found easy the integration of the SEG device into the rehabilitation schedule. Furthermore, the participants supported the simplicity of the device in high percentages of 84% for the control group and 80% for the patients, approving the overall design and configuration. In addition, all participants noticed that the SEG device was lightweight and, according to 92% of the control group and 80% of the patients, the device was comfortable.