Powered exoskeletons for gait rehabilitation and mobility assistance are currently available for the adult population and hold great promise for children with mobility limiting conditions. Described here is the development and key features of a modular, lightweight and customizable powered exoskeleton for assist-as-needed overground walking and gait rehabilitation. The pediatric lower-extremity gait system (PLEGS) exoskeleton contains bilaterally active hip, knee and ankle joints and assist-as-needed shared control for young children with lower-limb disabilities such as those present in the Cerebral Palsy, Spina Bifida and Spinal Cord Injured populations. The system is comprised of six joint control modules, one at each hip, knee and ankle joint. The joint control module, features an actuator and motor driver, microcontroller, torque sensor to enable assist-as-needed control, inertial measurement unit and system monitoring sensors. Bench-testing results for the proposed joint control module are also presented and discussed.
more »
« less
Navigating the FDA Medical Device Regulatory Pathways for Pediatric Lower Limb Exoskeleton Devices
There have been significant advances in the technologies for robot-assisted lower-limb rehabilitation in the last decade. However, the development of similar systems for children has been slow despite the fact that children with conditions such as cerebral palsy (CP), spina bifida (SB) and spinal cord injury (SCI) can benefit greatly from these technologies. Robotic assisted gait therapy (RAGT) has emerged as a way to increase gait training duration and intensity while decreasing the risk of injury to therapists. Robotic walking
devices can be coupled with motion sensing, electromyography (EMG), scalp electroencephalography (EEG) or other noninvasive methods of acquiring information about the user’s intent to design Brain-Computer Interfaces (BCI) for neuromuscular rehabilitation and control of powered exoskeletons. For users with SCI, BCIs could provide a method
of overground mobility closer to the natural process of the brain controlling the body’s movement during walking than mobility by wheelchair. For adults there are currently four FDA approved lower-limb exoskeletons that could be incorporated into such a BCI system, but there are no similar devices specifically designed for children, who present additional physical, neurological and cognitive developmental challenges. The current state of the art for pediatric RAGT relies on large clinical devices with high costs that limit accessibility. This can reduce the amount of therapy a child receives and slow rehabilitation progress. In many cases, lack of gait training can result in a reduction in the mobility, independence and overall quality of life for children with lower-limb disabilities. Thus, it is imperative to facilitate and accelerate the development of pediatric technologies for gait rehabilitation, including their
regulatory path. In this paper an overview of the U.S. Food and Drug Administration (FDA) clearance/approval process is presented. An example device has been used to navigate
important questions facing device developers focused on providing lower limb rehabilitation to children in home-based or other settings beyond the clinic.
more »
« less
- Award ID(s):
- 1650536
- NSF-PAR ID:
- 10212396
- Date Published:
- Journal Name:
- IEEE Systems Journal
- ISSN:
- 1932-8184
- Page Range / eLocation ID:
- 1 to 8
- Format(s):
- Medium: X
- Sponsoring Org:
- National Science Foundation
More Like this
-
-
Abstract In this review article, we present more than a decade of our work on the development of brain–computer interface (BCI) systems for the restoration of walking following neurological injuries such as spinal cord injury (SCI) or stroke. Most of this work has been in the domain of non-invasive electroencephalogram-based BCIs, including interfacing our system with a virtual reality environment and physical prostheses. Real-time online tests are presented to demonstrate the ability of able-bodied subjects as well as those with SCI to purposefully operate our BCI system. Extensions of this work are also presented and include the development of a portable low-cost BCI suitable for at-home use, our ongoing efforts to develop a fully implantable BCI for the restoration of walking and leg sensation after SCI, and our novel BCI-based therapy for stroke rehabilitation.more » « less
-
Neural decoding of human locomotion, including automated gait intention detection and continuous decoding of lower limb joint angles, has been of great interest in the field of Brain Machine Interface (BMI). However, neural decoding of gait in developing children has yet to be demonstrated. In this study, we collected physiological data (electroencephalography (EEG), electromyography (EMG)), and kinematic data from children performing different locomotion tasks. We also developed a state space estimation model to decode lower limb joint angles from scalp EEG. Fluctuations in the amplitude of slow cortical potentials of EEG in the delta band (0.1 – 3 Hz) were used for prediction. The decoding accuracies (Pearson’s r values) were promising (Hip: 0.71; Knee: 0.59; Ankle: 0.51). Our results demonstrate the feasibility of neural decoding of children walking and have implications for the development of a real-time closed-loop BMI system for the control of a pediatric exoskeleton.more » « less
-
Robotic exoskeletons can assist humans with walking by providing supplemental torque in proportion to the user's joint torque. Electromyographic (EMG) control algorithms can estimate a user's joint torque directly using real-time EMG recordings from the muscles that generate the torque. However, EMG signals change as a result of supplemental torque from an exoskeleton, resulting in unreliable estimates of the user's joint torque during active exoskeleton assistance. Here, we present an EMG control framework for robotic exoskeletons that provides consistent joint torque predictions across varying levels of assistance. Experiments with three healthy human participants showed that using diverse training data (from different levels of assistance) enables robust torque predictions, and that a convolutional neural network (CNN), but not a Kalman filter (KF), can capture the non-linear transformations in EMG due to exoskeleton assistance. With diverse training, the CNN could reliably predict joint torque from EMG during zero, low, medium, and high levels of exoskeleton assistance [root mean squared error (RMSE) below 0.096 N-m/kg]. In contrast, without diverse training, RMSE of the CNN ranged from 0.106 to 0.144 N-m/kg. RMSE of the KF ranged from 0.137 to 0.182 N-m/kg without diverse training, and did not improve with diverse training. When participant time is limited, training data should emphasize the highest levels of assistance first and utilize at least 35 full gait cycles for the CNN. The results presented here constitute an important step toward adaptive and robust human augmentation via robotic exoskeletons. This work also highlights the non-linear reorganization of locomotor output when using assistive exoskeletons; significant reductions in EMG activity were observed for the soleus and gastrocnemius, and a significant increase in EMG activity was observed for the erector spinae. Control algorithms that can accommodate spatiotemporal changes in muscle activity have broad implications for exoskeleton-based assistance and rehabilitation following neuromuscular injury.more » « less
-
null (Ed.)Abstract Hemiparetic walking after stroke is typically slow, asymmetric, and inefficient, significantly impacting activities of daily living. Extensive research shows that functional, intensive, and task-specific gait training is instrumental for effective gait rehabilitation, characteristics that our group aims to encourage with soft robotic exosuits. However, standard clinical assessments may lack the precision and frequency to detect subtle changes in intervention efficacy during both conventional and exosuit-assisted gait training, potentially impeding targeted therapy regimes. In this paper, we use exosuit-integrated inertial sensors to reconstruct three clinically meaningful gait metrics related to circumduction, foot clearance, and stride length. Our method corrects sensor drift using instantaneous information from both sides of the body. This approach makes our method robust to irregular walking conditions poststroke as well as usable in real-time applications, such as real-time movement monitoring, exosuit assistance control, and biofeedback. We validate our algorithm in eight people poststroke in comparison to lab-based optical motion capture. Mean errors were below 0.2 cm (9.9%) for circumduction, −0.6 cm (−3.5%) for foot clearance, and 3.8 cm (3.6%) for stride length. A single-participant case study shows our technique’s promise in daily-living environments by detecting exosuit-induced changes in gait while walking in a busy outdoor plaza.more » « less
- Free Publicly Accessible Full Text
-
Accepted Manuscript1.0
- Journal Article:
- https://doi.org/10.1109/JSYST.2020.3025111
