Mixed methods usability evaluation of an assistive wearable robotic hand orthosis for people with spinal cord injury.

BACKGROUND: Robotic hand orthoses (RHO) aim to provide grasp assistance for people with sensorimotor hand impairment during daily tasks. Many of such devices have been shown to bring a functional benefit to the user. However, assessing functional benefit is not sufficient to evaluate the usability of such technologies for daily life application. A comprehensive and structured evaluation of device usability not only focusing on effectiveness but also efficiency and satisfaction is required, yet often falls short in existing literature. Mixed methods evaluations, i.e., assessing a combination of quantitative and qualitative measures, allow to obtain a more holistic picture of all relevant aspects of device usability. Considering these aspects already in early development stages allows to identify design issues and generate generalizable benchmarks for future developments. METHODS: We evaluated the short-term usability of the RELab tenoexo, a RHO for hand function assistance, in 15 users with tetraplegia after a spinal cord injury through a comprehensive mixed methods approach. We collected quantitative data using the Action Research Arm Test (ARAT), the System Usability Scale (SUS), and timed tasks such as the donning process. In addition, qualitative data were collected through semi-structured interviews and user observations, and analyzed with a thematic analysis to enhance the usability evaluation. All insights were attributed and discussed in relation to specifically defined usability attributes such as comfort, ease of use, functional benefit, and safety. RESULTS: The RELab tenoexo provided an immediate functional benefit to the users, resulting in a mean improvement of the ARAT score by 5.8 points and peaking at 15 points improvement for one user (clinically important difference: 5.7 points). The mean SUS rating of 60.6 represents an adequate usability, however, indicating that especially the RHO donning (average task time = 295 s) was perceived as too long and cumbersome. The participants were generally very satisfied with the ergonomics (size, dimensions, fit) of the RHO. Enhancing the ease of use, specifically in donning, increasing the provided grasping force, as well as the availability of tailoring options and customization were identified as main improvement areas to promote RHO usability. CONCLUSION: The short-term usability of the RELab tenoexo was thoroughly evaluated with a mixed methods approach, which generated valuable data to improve the RHO in future iterations. In addition, learnings that might be transferable to the evaluation and design of other RHO were generated, which have the potential to increase the daily life applicability and acceptance of similar technologies.

Assessment of jugular bulb variability based on 3D surface models: quantitative measurements and surgical implications.

PURPOSE: High-riding jugular bulbs (JBs) among other anatomical variations can limit surgical access during lateral skull base surgery or middle ear surgery and must be carefully assessed preoperatively. We reconstruct 3D surface models to evaluate recent JB classification systems and assess the variability in the JB and surrounding structures. METHODS: 3D surface models were reconstructed from 46 temporal bones from computed tomography scans. Two independent raters visually assessed the height of the JB in the 3D models. Distances between the round window and the JB dome were measured to evaluate the spacing of this area. Additional distances between landmarks on surrounding structures were measured and statistically analyzed to describe the anatomical variability between and within subjects. RESULTS: The visual classification revealed that 30% of the specimens had no JB, 63% a low JB, and 7% a high-riding JB. The measured mean distance from the round window to the jugular bulb ranges between 3.22 ± 0.97 mm and 10.34 ± 1.41 mm. The distance measurement (error rate 5%) was more accurate than the visual classification (error rate 15%). The variability of the JB was higher than for the surrounding structures. No systematic laterality was found for any structure. CONCLUSION: Qualitative analysis in 3D models can contribute to a better spatial orientation in the lateral skull base and, thereby, have important implications during planning of middle ear and lateral skull base surgery.

Hearing-Preserving Approaches to the Internal Auditory Canal: Feasibility Assessment from the Perspective of an Endoscope.

OBJECTIVE: Minimally invasive transcanal transpromontorial endoscopic approaches to the internal auditory canal sacrifice the cochlea. Two hearing-preserving approaches, the exclusively endoscopic transcanal infracochlear approach and the endoscope-assisted transmastoid retrolabyrinthine approach, have been controversially discussed in the literature. In this study, we examine the feasibility of these 2 approaches by means of three-dimensional surface models, a population-based analysis of the available surgical space, and dissections in human whole-head specimens. METHODS: We reconstructed three-dimensional surface models based on clinical high-resolution computed tomography scans of 53 adult temporal bones. For both approaches, we measured the maximal extensions and the area of the surgical access windows located between landmarks on the surrounding anatomic structures. We then identified the limiting extensions and derived the cumulative distribution to describe the available surgical space. Dissections were performed to validate the corridors and landmark selection. RESULTS: The limiting extension for the infrachochlear approach is 7.0 ± 2.7 mm from the round window to the dome of the jugular bulb. The limiting extension for the retrolabyrinthine approach is 6.4 ± 1.5 mm from the dura of the posterior fossa to the facial nerve. The cumulative distribution shows that 80% of the cohort have access window extensions ≥3 mm for both approaches. CONCLUSIONS: This study shows that in a high percentage of the measured cohort, the access windows are sufficiently large for endoscopic approaches to the internal auditory canal. With appropriate instrumentation, these hearing-preserving minimally invasive approaches may evolve into alternatives to surgical treatment.

Novel Multiportal Approach to the Internal Auditory Canal for Hearing-Preserving Surgery: Feasibility Assessment in Dissections.

OBJECTIVE: State-of-the-art, minimally invasive endoscopic transcanal surgery of the internal auditory canal (IAC) sacrifices the cochlea with complete hearing loss. With a combination of the transcanal infracochlear and transmastoid retrolabyrinthine approaches, we aim to preserve hearing and enable minimally invasive surgical treatment of vestibular schwannoma. In this study, we investigate the anatomical indications and the feasibility of both approaches in dissections, in human whole head specimens. METHODS: We operated whole head anatomical specimens with a four-handed technique, using the retrolabyrinthine approach as the main surgical corridor and the infracochlear approach for endoscopic visualization. We tested 4 different powered surgical systems. We collected intraoperative data on the size of the access windows, the surgical freedom, and the exposed area of the IAC. Finally, we evaluated the outcome in postoperative computed tomography scans. RESULTS: Six out of 14 sides were anatomically suitable and qualified for the surgery based on preoperative computed tomography. In all attempted sides, the IAC could be reached and opened, leaving the ossicular chain and the labyrinth intact. 51%-75% of the length and 22%-40% of the circumference of the IAC could be exposed. All tested instruments were beneficial at different stages of the surgery. The four-handed technique enabled good maneuverability of the instruments. CONCLUSIONS: The combined multiportal approach to the IAC is feasible with a good surgical exposure and full anatomical preservation of hearing. State-of-the-art surgical instruments in specimens with suitable anatomy are sufficient to perform this approach.

Fully Wearable Actuated Soft Exoskeleton for Grasping Assistance in Everyday Activities.

Worldwide, over 50 million people suffer from persistent hand impairments after stroke or spinal cord injury (SCI). This results in major loss of independence and quality of life. Robotic hand exoskeletons can compensate for lost motor function and assist in grasping tasks performed in everyday activities. Several recent prototypes can partially provide this assistance. However, it remains challenging to integrate the dexterity required for daily tasks in a safe and user-friendly design that is acceptable for daily use in subjects with neuromotor hand impairments. We present the design of RELab tenoexo; a fully wearable assistive soft hand exoskeleton for daily activities. We present sleek mechanisms for a hand module that generates the four most frequently used grasp types, employing a remote actuation system that reduces weight on the hand. For optimal assistance and highest adaptability, we present various design and control options to customize the modular device, along with an automated tailoring algorithm that allows automatically generated hand modules for individual users. Mechanical evaluation shows that RELab tenoexo covers the range of motion and the fingertip forces required to assist users in up to 80% of all grasping activities. In user tests, we find that the low weight, unintrusive size, high wearing comfort, and appealing appearance are beneficial for user acceptance and usability in daily life. Finally, we demonstrate that RELab tenoexo leads to an immediate improvement of the functional grasping ability in a subject with SCI.

Remote Actuation Systems for Fully Wearable Assistive Devices: Requirements, Selection, and Optimization for Out-of-the-Lab Application of a Hand Exoskeleton.

Wearable robots assist individuals with sensorimotor impairment in daily life, or support industrial workers in physically demanding tasks. In such scenarios, low mass and compact design are crucial factors for device acceptance. Remote actuation systems (RAS) have emerged as a popular approach in wearable robots to reduce perceived weight and increase usability. Different RAS have been presented in the literature to accommodate for a wide range of applications and related design requirements. The push toward use of wearable robotics in out-of-the-lab applications in clinics, home environments, or industry created a shift in requirements for RAS. In this context, high durability, ergonomics, and simple maintenance gain in importance. However, these are only rarely considered and evaluated in research publications, despite being drivers for device abandonment by end-users. In this paper, we summarize existing approaches of RAS for wearable assistive technology in a literature review and compare advantages and disadvantages, focusing on specific evaluation criteria for out-of-the-lab applications to provide guidelines for the selection of RAS. Based on the gained insights, we present the development, optimization, and evaluation of a cable-based RAS for out-of-the-lab applications in a wearable assistive soft hand exoskeleton. The presented RAS features full wearability, high durability, high efficiency, and appealing design while fulfilling ergonomic criteria such as low mass and high wearing comfort. This work aims to support the transfer of RAS for wearable robotics from controlled lab environments to out-of-the-lab applications.

PEXO - A Pediatric Whole Hand Exoskeleton for Grasping Assistance in Task-Oriented Training.

Children with hand motor impairment due to cerebral palsy, traumatic brain injury, or pediatric stroke are considerably affected in their independence, development, and quality of life. Treatment conventionally includes task-oriented training in occupational therapy. While dose and intensity of hand therapy can be promoted through technology, these approaches are mostly limited to large stationary robotic devices for non-task-oriented training, or passive wearable devices for children with mild impairments. Here we present PEXO, a fully wearable actuated pediatric hand exoskeleton to cover the special needs of children (6 to 12 years of age) with strong impairments in hand function. Through three degrees of freedom, PEXO provides assistance in various grasp types needed for the execution of functional tasks. It is lightweight, water proof, and inherently interacts safely with the user. It meets mechanical requirements such as force, fast closing movement, and battery lifetime derived from literature and discussions with clinicians. Appealing appearance, user-friendly design, and intuitive control with visual feedback of forearm muscle activity should keep the user motivated during training in the clinic or at home. A pilot test with a 6-years old child with stroke showed that PEXO can provide assistance in grasping various objects weighing up to 0.5 kg. These are promising first results on the way to make hand exoskeletons accessible for children with neuromotor disorders.

Fully embedded myoelectric control for a wearable robotic hand orthosis.

To prevent learned non-use of the affected hand in chronic stroke survivors, rehabilitative training should be continued after discharge from the hospital. Robotic hand orthoses are a promising approach for home rehabilitation. When combined with intuitive control based on electromyography, the therapy outcome can be improved. However, such systems often require extensive cabling, experience in electrode placement and connection to external computers. This paper presents the framework for a stand-alone, fully wearable and real-time myoelectric intention detection system based on the Myo armband. The hard and software for real-time gesture classification were developed and combined with a routine to train and customize the classifier, leading to a unique ease of use. The system including training of the classifier can be set up within less than one minute. Results demonstrated that: (1) the proposed algorithm can classify five gestures with an accuracy of 98%, (2) the final system can online classify three gestures with an accuracy of 94.3% and, in a preliminary test, (3) classify three gestures from data acquired from mildly to severely impaired stroke survivors with an accuracy of over 78.8%. These results highlight the potential of the presented system for electromyography-based intention detection for stroke survivors and, with the integration of the system into a robotic hand orthosis, the potential for a wearable platform for all day robot-assisted home rehabilitation.