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Risk management and regulations for lower limb medical exoskeletons: a review.

ABSTRACT: Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human-machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate.

SUBMITTER: He Y

PROVIDER: S-EPMC5431736 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Risk management and regulations for lower limb medical exoskeletons: a review.

He Yongtian Y Eguren David D Luu Trieu Phat TP Contreras-Vidal Jose L JL

Medical devices (Auckland, N.Z.) 20170509

Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this ind ...[more]

PMID: 28533700

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Project description:BackgroundMany lower-limb exoskeletons have been developed to assist gait, exhibiting a large range of control methods. The goal of this paper is to review and classify these control strategies, that determine how these devices interact with the user.MethodsIn addition to covering the recent publications on the control of lower-limb exoskeletons for gait assistance, an effort has been made to review the controllers independently of the hardware and implementation aspects. The common 3-level structure (high, middle, and low levels) is first used to separate the continuous behavior (mid-level) from the implementation of position/torque control (low-level) and the detection of the terrain or user's intention (high-level). Within these levels, different approaches (functional units) have been identified and combined to describe each considered controller.Results291 references have been considered and sorted by the proposed classification. The methods identified in the high-level are manual user input, brain interfaces, or automatic mode detection based on the terrain or user's movements. In the mid-level, the synchronization is most often based on manual triggers by the user, discrete events (followed by state machines or time-based progression), or continuous estimations using state variables. The desired action is determined based on position/torque profiles, model-based calculations, or other custom functions of the sensory signals. In the low-level, position or torque controllers are used to carry out the desired actions. In addition to a more detailed description of these methods, the variants of implementation within each one are also compared and discussed in the paper.ConclusionsBy listing and comparing the features of the reviewed controllers, this work can help in understanding the numerous techniques found in the literature. The main identified trends are the use of pre-defined trajectories for full-mobilization and event-triggered (or adaptive-frequency-oscillator-synchronized) torque profiles for partial assistance. More recently, advanced methods to adapt the position/torque profiles online and automatically detect terrains or locomotion modes have become more common, but these are largely still limited to laboratory settings. An analysis of the possible underlying reasons of the identified trends is also carried out and opportunities for further studies are discussed.

Project description:Gait disorders can reduce the quality of life for people with neuromuscular impairments. Therefore, walking recovery is one of the main priorities for counteracting sedentary lifestyle, reducing secondary health conditions and restoring legged mobility. At present, wearable powered lower-limb exoskeletons are emerging as a revolutionary technology for robotic gait rehabilitation. This systematic review provides a comprehensive overview on wearable lower-limb exoskeletons for people with neuromuscular impairments, addressing the following three questions: (1) what is the current technological status of wearable lower-limb exoskeletons for gait rehabilitation?, (2) what is the methodology used in the clinical validations of wearable lower-limb exoskeletons?, and (3) what are the benefits and current evidence on clinical efficacy of wearable lower-limb exoskeletons? We analyzed 87 clinical studies focusing on both device technology (e.g., actuators, sensors, structure) and clinical aspects (e.g., training protocol, outcome measures, patient impairments), and make available the database with all the compiled information. The results of the literature survey reveal that wearable exoskeletons have potential for a number of applications including early rehabilitation, promoting physical exercise, and carrying out daily living activities both at home and the community. Likewise, wearable exoskeletons may improve mobility and independence in non-ambulatory people, and may reduce secondary health conditions related to sedentariness, with all the advantages that this entails. However, the use of this technology is still limited by heavy and bulky devices, which require supervision and the use of walking aids. In addition, evidence supporting their benefits is still limited to short-intervention trials with few participants and diversity among their clinical protocols. Wearable lower-limb exoskeletons for gait rehabilitation are still in their early stages of development and randomized control trials are needed to demonstrate their clinical efficacy.

Project description:Assist-as-needed (AAN) algorithms for the control of lower extremity rehabilitation robots can promote active participation of patients during training while adapting to their individual performances and impairments. The implementation of such controllers requires the adaptation of a control parameter (often the robot impedance) based on a performance (or error) metric. The choice of how an adaptive impedance controller is formulated implies different challenges and possibilities for controlling the patient's leg movement. In this paper, we analyze the characteristics and limitations of controllers defined in two commonly used formulations: joint and end-point space, exploring especially the implementation of an AAN algorithm. We propose then, as a proof-of-concept, an AAN impedance controller that combines the strengths of working in both spaces: a hybrid joint/end-point impedance controller. This approach gives the possibility to adapt the end-point stiffness in magnitude and direction in order to provide a support that targets the kinematic deviations of the end-point with the appropriate force vector. This controller was implemented on a two-link rehabilitation robot for gait training-the Lokomat®Pro V5 (Hocoma AG, Switzerland) and tested on 5 able-bodied subjects and 1 subject with Spinal Cord Injury. Our experiments show that the hybrid controller is a feasible approach for exoskeleton devices and that it could exploit the benefits of the end-point controller in shaping a desired end-point stiffness and those of the joint controller to promote the correct angular changes in the trajectories of the joints. The adaptation algorithm is able to adapt the end-point stiffness based on the subject's performance in different gait phases, i.e., the robot can render a higher stiffness selectively in the direction and gait phases where the subjects perform with larger kinematic errors. The proposed approach can potentially be generalized to other robotic applications for rehabilitation or assistive purposes.

Project description:Lower-limb wearable robotic devices can improve clinical gait and reduce energetic demand in healthy populations. To help enable real-world use, we sought to examine how assistance should be applied in variable gait conditions and suggest an approach derived from knowledge of human locomotion mechanics to establish a 'roadmap' for wearable robot design. We characterized the changes in joint mechanics during walking and running across a range of incline/decline grades and then provide an analysis that informs the development of lower-limb exoskeletons capable of operating across a range of mechanical demands. We hypothesized that the distribution of limb-joint positive mechanical power would shift to the hip for incline walking and running and that the distribution of limb-joint negative mechanical power would shift to the knee for decline walking and running. Eight subjects (6M,2F) completed five walking (1.25 m s-1) trials at -8.53°, -5.71°, 0°, 5.71°, and 8.53° grade and five running (2.25 m s-1) trials at -5.71°, -2.86°, 0°, 2.86°, and 5.71° grade on a treadmill. We calculated time-varying joint moment and power output for the ankle, knee, and hip. For each gait, we examined how individual limb-joints contributed to total limb positive, negative and net power across grades. For both walking and running, changes in grade caused a redistribution of joint mechanical power generation and absorption. From level to incline walking, the ankle's contribution to limb positive power decreased from 44% on the level to 28% at 8.53° uphill grade (p < 0.0001) while the hip's contribution increased from 27% to 52% (p < 0.0001). In running, regardless of the surface gradient, the ankle was consistently the dominant source of lower-limb positive mechanical power (47-55%). In the context of our results, we outline three distinct use-modes that could be emphasized in future lower-limb exoskeleton designs 1) Energy injection: adding positive work into the gait cycle, 2) Energy extraction: removing negative work from the gait cycle, and 3) Energy transfer: extracting energy in one gait phase and then injecting it in another phase (i.e., regenerative braking).

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Risk management and regulations for lower limb medical exoskeletons: a review.

Publications

Risk management and regulations for lower limb medical exoskeletons: a review.

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