An official website of the United States government
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
- 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
-
null (Ed.)Abstract Studying the human brain during interpersonal interaction allows us to answer many questions related to motor control and cognition. For instance, what happens in the brain when two people walking side by side begin to change their gait and match cadences? Adapted from the neuroimaging techniques used in single-brain measurements, hyperscanning (HS) is a technique used to measure brain activity from two or more individuals simultaneously. Thus far, HS has primarily focused on healthy participants during social interactions in order to characterize inter-brain dynamics. Here, we advocate for expanding the use of this electroencephalography hyperscanning (EEG-HS) technique to rehabilitation paradigms in individuals with neurological diagnoses, namely stroke, spinal cord injury (SCI), Parkinson’s disease (PD), and traumatic brain injury (TBI). We claim that EEG-HS in patient populations with impaired motor function is particularly relevant and could provide additional insight on neural dynamics, optimizing rehabilitation strategies for each individual patient. In addition, we discuss future technologies related to EEG-HS that could be developed for use in the clinic as well as technical limitations to be considered in these proposed settings.more » « less
-
Robotic lower limb exoskeletons have been shown to successfully provide joint torques to assist human subjects during walking. Assisting the wearer during gait perturbations to prevent falls still poses a challenge due to specific requirements of the device, and complex bipedal dynamics of recovery. In this study, we present a hip exoskeleton device with pneumatically actuated abduction/adduction motion to provide hip torque for assisting with lateral balance. The device was designed to be wearable, allow integration with previously developed wearable gait perturbation detection system and knee exoskeleton, and produce fast actuation to provide assistive joint torque during gait perturbations. We present the results of the experimental benchtop tests of the device. The maximum torque output and rate of torque development were characterized using a load cell. The maximum angular displacement, with added weights to simulate the leg inertia, was recorded using an inertial measurement unit sensor. Lastly, a preliminary test on a human subject demonstrated that the device, when exerting instantaneous hip abduction torque during swing walking gait, can effectively modify foot placement in the lateral direction. This work contributes towards developing exoskeleton control strategies for assistance during gait perturbations to prevent falls.more » « less
- Free Publicly Accessible Full Text
-
Accepted Manuscript1.0
- Journal Article:
- https://doi.org/10.1109/JSYST.2020.3025111
