Clinical Test of a Wearable, High DOF, Spring Powered Hand Exoskeleton (HandSOME II).
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SUBMITTER: Casas R
PROVIDER: S-EPMC8462990 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Introduction: Spasticity is a typical motor disorder in patients affected by stroke. Typically post-stroke rehabilitation consists of repetition of mobilization exercises on impaired limbs, aimed to reduce muscle hypertonia and mitigate spastic reflexes. It is currently strongly debated if the treatment's effectiveness improves with the timeliness of its adoption; in particular, starting intensive rehabilitation as close as possible to the stroke event may counteract the growth and postpone the onset of spasticity. In this paper we present a phase-II clinical validation of a robotic exoskeleton in treating subacute post-stroke patients. Methods: Seventeen post-stroke patients participated in 10 daily rehabilitation sessions using the NEUROExos Elbow Module exoskeleton, each one lasting 45 min: the exercises consisted of isokinetic passive mobilization of the elbow, with torque threshold to detect excessive user's resistance to the movement. We investigated the safety by reporting possible adverse events, such as mechanical, electrical or software failures of the device or injuries or pain experienced by the patient. As regards the efficacy, the Modified Ashworth Scale, was identified as primary outcome measure and the NEEM metrics describing elbow joint resistance to passive extension (i.e., maximum extension torque and zero-torque angle) as secondary outcomes. Results: During the entire duration of the treatments no failures or adverse events for the patients were reported. No statistically significant differences were found in the Modified Ashworth Scale scores, between pre-treatment and post-treatment and between post-treatment and follow-up sessions, indicating the absence of spasticity increase throughout (14 days) and after (3-4 months follow-up) the treatment. Exoskeleton metrics confirmed the absence of significant difference in between pre- and post-treatment data, whereas intra-session data highlighted significant differences in the secondary outcomes, toward a decrease of the subject's joint resistance. Conclusions: The results show that our robotic exoskeleton can be safely used for prolonged sessions in post-stroke and suggest that intensive early rehabilitation treatment may prevent the occurrence of spasticity at a later stage. Moreover, the NEEM metrics were found to be reliable compared to the Modified Ashworth Scale and sensitive to revealing intra-session changes of elbow resistance to passive extension, in agreement with clinical evidences.
| S-EPMC5427118 | biostudies-literature
Project description:A shared design goal for most robotic lower limb exoskeletons is to reduce the metabolic cost of locomotion for the user. Despite this, only a limited amount of devices was able to actually reduce user metabolic consumption. Preservation of the natural motion kinematics was defined as an important requirement for a device to be metabolically beneficial. This requires the inclusion of all human degrees of freedom (DOF) in a design, as well as perfect alignment of the rotation axes. As perfect alignment is impossible, compensation for misalignment effects should be provided. A misalignment compensation mechanism for a 3-DOF system is presented in this paper. It is validated by the implementation in a bilateral hip exoskeleton, resulting in a compact and lightweight device that can be donned fast and autonomously, with a minimum of required adaptations. Extensive testing of the prototype has shown that hip range of motion of the user is maintained while wearing the device and this for all three hip DOFs. This allowed the users to maintain their natural motion patterns when they are walking with the novel hip exoskeleton.
| S-EPMC5534269 | biostudies-other
Project description:Robotic devices are being employed in more and more sectors to enhance, streamline, and augment the outcomes of a wide variety of human activities. Wearable robots arise indeed as of-vital-importance tools for telerehabilitation or home assistance targeting people affected by motor disabilities. In particular, the field of "Robotics for Medicine and Healthcare" is attracting growing interest. The development of such devices is a primarily addressed topic since the increasing number of people in need of rehabilitation or assistive therapies (due to population aging) growingly weighs on the healthcare systems of the nation. Besides, the necessity to move to clinics represents an additional logistic burden for patients and their families. Among the various body parts, the hand is specially investigated since it most ensures the independence of an individual, and thus, the restoration of its dexterity is considered a high priority. In this study, the authors present the development of a fully wearable, portable, and tailor-made hand exoskeleton designed for both home assistance and telerehabilitation. Its purpose is either to assist patients during activities of daily living by running a real-time intention detection algorithm or to be used for remotely supervised or unsupervised rehabilitation sessions by performing exercises preset by therapists. Throughout the mechatronic design process, special attention has been paid to the complete wearability and comfort of the system to produce a user-friendly device capable of assisting people in their daily life or enabling recorded home rehabilitation sessions allowing the therapist to monitor the state evolution of the patient. Such a hand exoskeleton system has been designed, manufactured, and preliminarily tested on a subject affected by spinal muscular atrophy, and some results are reported at the end of the article.
| S-EPMC8568131 | biostudies-literature
Project description:BackgroundPowered hand exoskeletons are an emerging technology that have shown promise in assisting individuals with impaired hand function. A number of hand exoskeleton designs have been described in the literature; however, the majority have not been supported by patient-oriented criteria.ObjectiveThe aim of this study was to define preliminary end-user needs and expectations for an assistive hand exoskeleton.Study designExplorative interview and case series.MethodsSix clinicians and eight individuals with impaired hand function were interviewed in small groups or individually. A standardized list of questions was used to elicit feedback on specific design criteria or promote the discovery of new criteria. In addition, three participants with impaired hand function returned for a second session where hand characteristics, such as range of motion and force required to flex/extend fingers, were recorded to further quantify design requirements.ResultsInterview responses indicated that there was general consensus among participants on criteria relating to important grasp patterns, grip strength, wear time, and acceptable bulk/weight. However, interview responses and hand characteristics also revealed important differences between individuals with impaired hand function.ConclusionQualitative and quantitative data were collected to develop an understanding of end-user design requirements for assistive hand exoskeletons. Although the data collected were helpful in identifying some preliminary criteria, differences between participants exist and identifying a universal set of criteria applicable across individuals with impaired hand function is challenging. This work reinforces the importance of involving users of rehabilitation technology in the device development process.
| S-EPMC8404210 | biostudies-literature
Project description:This paper presents the EXOTIC- a novel assistive upper limb exoskeleton for individuals with complete functional tetraplegia that provides an unprecedented level of versatility and control. The current literature on exoskeletons mainly focuses on the basic technical aspects of exoskeleton design and control while the context in which these exoskeletons should function is less or not prioritized even though it poses important technical requirements. We considered all sources of design requirements, from the basic technical functions to the real-world practical application. The EXOTIC features: (1) a compact, safe, wheelchair-mountable, easy to don and doff exoskeleton capable of facilitating multiple highly desired activities of daily living for individuals with tetraplegia; (2) a semi-automated computer vision guidance system that can be enabled by the user when relevant; (3) a tongue control interface allowing for full, volitional, and continuous control over all possible motions of the exoskeleton. The EXOTIC was tested on ten able-bodied individuals and three users with tetraplegia caused by spinal cord injury. During the tests the EXOTIC succeeded in fully assisting tasks such as drinking and picking up snacks, even for users with complete functional tetraplegia and the need for a ventilator. The users confirmed the usability of the EXOTIC.
| S-EPMC9502221 | biostudies-literature
Project description:Stroke is the second leading cause of death and one of the leading causes of disability in the world. According to the World Health Organization, 11 million people suffer a stroke yearly. The cost of the disease is exorbitant, and the most widely used treatment is conventional physiotherapy. Therefore, assistive technology emerges to optimize rehabilitation and functional capabilities, but cost, robustness, usability, and long-term results still restrict the technology selection. This work aimed to develop a low-cost ankle orthosis, the G-Exos, a wearable exoskeleton to increase motor capability by assisting dorsiflexion, plantarflexion, and ankle stability. A hybrid system provided near-natural gait movements using active, motor, and passive assistance, elastic band. The system was validated with 10 volunteers with foot drop: seven with stroke, two with incomplete spinal cord injury (SCI), and one with acute inflammatory transverse myelitis (ATM). The G-Exos showed assistive functionality for gait movement. A Friedman test showed a significant difference in dorsiflexion amplitude with the use of the G-Exos compared to gait without the use of the G-Exos [x 2 (3) = 98.56, p < 0.001]. In addition, there was also a significant difference in ankle eversion and inversion comparing walking with and without the G-Exos [x 2 (3) = 36.12, p < 0.001]. The G-Exos is a robust, lightweight, and flexible assistive technology device to detect the gait phase accurately and provide better human-machine interaction. G-Exos training improved capability to deal with gait disorders, usability, and motor and functional recovery. Wearable assistive technologies lead to a better quality of life and contribute using in activities of daily living.
| S-EPMC9684314 | biostudies-literature
Project description: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.
| S-EPMC7876397 | biostudies-literature
Project description:BackgroundAssistive hand exoskeletons are promising tools to restore hand function after cervical spinal cord injury (SCI) but assessing their specific impact on bimanual hand and arm function is limited due to lack of reliable and valid clinical tests. Here, we introduce the Berlin Bimanual Test for Tetraplegia (BeBiTT) and demonstrate its psychometric properties and sensitivity to assistive hand exoskeleton-related improvements in bimanual task performance.MethodsFourteen study participants with subacute cervical SCI performed the BeBiTT unassisted (baseline). Thereafter, participants repeated the BeBiTT while wearing a brain/neural hand exoskeleton (B/NHE) (intervention). Online control of the B/NHE was established via a hybrid sensorimotor rhythm-based brain-computer interface (BCI) translating electroencephalographic (EEG) and electrooculographic (EOG) signals into open/close commands. For reliability assessment, BeBiTT scores were obtained by four independent observers. Besides internal consistency analysis, construct validity was assessed by correlating baseline BeBiTT scores with the Spinal Cord Independence Measure III (SCIM III) and Quadriplegia Index of Function (QIF). Sensitivity to differences in bimanual task performance was assessed with a bootstrapped paired t-test.ResultsThe BeBiTT showed excellent interrater reliability (intraclass correlation coefficients > 0.9) and internal consistency (α = 0.91). Validity of the BeBiTT was evidenced by strong correlations between BeBiTT scores and SCIM III as well as QIF. Wearing a B/NHE (intervention) improved the BeBiTT score significantly (p < 0.05) with high effect size (d = 1.063), documenting high sensitivity to intervention-related differences in bimanual task performance.ConclusionThe BeBiTT is a reliable and valid test for evaluating bimanual task performance in persons with tetraplegia, suitable to assess the impact of assistive hand exoskeletons on bimanual function.
| S-EPMC9881328 | biostudies-literature
Project description:Wearable sensors, especially pressure sensors, have become an indispensable part of life when reflecting human interactions and surroundings. However, the difficulties in technology and production-cost still limit their applicability in the field of human monitoring and healthcare. Herein, we propose a fabrication method with flexible, waterproof, thin, and high-performance circuits - based on hand-drawing for pressure sensors. The shape of the sensor is drawn on the pyralux film without assistance from any designing software and the wet-tissues coated by CNTs act as a sensing layer. Such sensor showed a sensitivity (~0.2 kPa-1) while ensuring thinness (~0.26 mm) and flexibility for touch detection or breathing monitoring. More especially, our sensor is waterproof for underwater wearable applications, which is a drawback of conventional paper-based sensors. Its outstanding capability is demonstrated in a real application when detecting touch actions to control a phone, while the sensor is dipped underwater. In addition, by leveraging machine learning technology, these touch actions were processed and classified to achieve highly accurate monitoring (up to 94%). The available materials, easy fabrication techniques, and machine learning algorithms are expected to bring significant contributions to the development of hand-drawing sensors in the future.
| S-EPMC8381950 | biostudies-literature
Project description:Powered exoskeletons have become available for overground ambulation in persons with paralyses due to spinal cord injury (SCI) who have intact upper extremity function and are able to maintain upright balance using forearm crutches. To ambulate in an exoskeleton, the user must acquire the ability to maintain balance while standing, sitting and appropriate weight shifting with each step. This can be a challenging task for those with deficits in sensation and proprioception in their lower extremities. This manuscript describes screening criteria and a training program developed at the James J. Peters VA Medical Center, Bronx, NY to teach users the skills needed to utilize these devices in institutional, home or community environments. Before training can begin, potential users are screened for appropriate range of motion of the hip, knee and ankle joints. Persons with SCI are at an increased risk of sustaining lower extremity fractures, even with minimal strain or trauma, therefore a bone mineral density assessment is performed to reduce the risk of fracture. Also, as part of screening, a physical examination is performed in order to identify additional health-related contraindications. Once the person has successfully passed all screening requirements, they are cleared to begin the training program. The device is properly adjusted to fit the user. A series of static and dynamic balance tasks are taught and performed by the user before learning to walk. The person is taught to ambulate in various environments ranging from indoor level surfaces to outdoors over uneven or changing surfaces. Once skilled enough to be a candidate for home use with the exoskeleton, the user is then required to designate a companion-walker who will train alongside them. Together, the pair must demonstrate the ability to perform various advanced tasks in order to be permitted to use the exoskeleton in their home/community environment.
| S-EPMC4927801 | biostudies-literature