Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation.

OBJECTIVE: The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., Korea, called the Gait Enhancing and Motivating System-Hip (GEMS-H), in assistance mode only with the poststroke population in an outpatient-rehabilitation setting. METHODS: Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6-8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation. RESULTS: By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device. CONCLUSIONS: Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov (NCT04285060).

Modular hip exoskeleton improves walking function and reduces sedentary time in community-dwelling older adults.

BACKGROUND: Despite the benefits of physical activity for healthy physical and cognitive aging, 35% of adults over the age of 75 in the United States are inactive. Robotic exoskeleton-based exercise studies have shown benefits in improving walking function, but most are conducted in clinical settings with a neurologically impaired population. Emerging technology is starting to enable easy-to-use, lightweight, wearable robots, but their impact in the otherwise healthy older adult population remains mostly unknown. For the first time, this study investigates the feasibility and efficacy of using a lightweight, modular hip exoskeleton for in-community gait training in the older adult population to improve walking function. METHODS: Twelve adults over the age of 65 were enrolled in a gait training intervention involving twelve 30-min sessions using the Gait Enhancing and Motivating System for Hip in their own senior living community. RESULTS: Performance-based outcome measures suggest clinically significant improvements in balance, gait speed, and endurance following the exoskeleton training, and the device was safe and well tolerated. Gait speed below 1.0 m/s is an indicator of fall risk, and two out of the four participants below this threshold increased their self-selected gait speed over 1.0 m/s after intervention. Time spent in sedentary behavior also decreased significantly. CONCLUSIONS: This intervention resulted in greater improvements in speed and endurance than traditional exercise programs, in significantly less time. Together, our results demonstrated that exoskeleton-based gait training is an effective intervention and novel approach to encouraging older adults to exercise and reduce sedentary time, while improving walking function. Future work will focus on whether the device can be used independently long-term by older adults as an everyday exercise and community-use personal mobility device. Trial registration This study was retrospectively registered with ClinicalTrials.gov (ID: NCT05197127).

Exercise with a wearable hip-assist robot improved physical function and walking efficiency in older adults.

Wearable assistive robotics has emerged as a promising technology to supplement or replace motor functions and to retrain people recovering from an injury or living with reduced mobility. We developed delayed output feedback control for a wearable hip-assistive robot, the EX1, to provide gait assistance. Our purpose in this study was to investigate the effects of long-term exercise with EX1 on gait, physical function, and cardiopulmonary metabolic energy efficiency in elderly people. This study used parallel experimental (exercise with EX1) and control groups (exercise without EX1). A total of 60 community-dwelling elderly persons participated in 18 exercise intervention sessions during 6 weeks, and all participants were assessed at 5 time points: before exercise, after 9 exercise sessions, after 18 sessions, and 1 month and 3 months after the last session. The spatiotemporal gait parameters, kinematics, kinetics, and muscle strength of the trunk and lower extremities improved more after exercise with EX1 than in that without EX1. Furthermore, the effort of muscles over the trunk and lower extremities throughout the total gait cycle (100%) significantly decreased after exercise with EX1. The net metabolic energy costs during walking significantly improved, and functional assessment scores improved more in the experimental group than in the control group. Our findings provide evidence supporting the application of EX1 in physical activity and gait exercise is effective to improve age-related declines in gait, physical function, and cardiopulmonary metabolic efficiency among older adults.

An assistance approach for a powered knee exoskeleton during level walking and the effects on metabolic cost.

In this paper, we propose a walking assistance method based on intrinsic gait events for level walking in a powered knee exoskeleton. The proposed method utilizes three gait events in order to determine the timing of initiation and termination for assistance torque profiles. This method plans uni-directional torque profiles for each flexion and extension movement for the next step and executes them in a feedfor-ward manner. It has the advantages of easy to adjust the assistance timing, intensity, and duration according to wearer's preference. In experiments, we investigated that the increase of metabolic cost was close to zero when worn and walked with our portable powered knee exoskeleton by the proposed assistance method compared with walking without wearing it on the treadmill.

Natural gait event-based level walking assistance with a robotic hip exoskeleton.

In this paper, we present an assistance strategy for level walking by using a robotic hip exoskeleton. Our strategy utilizes a foot contact event estimated by an inertial measurement unit (IMU) on the pelvis. The gait cycle is composed of three phases. The transitions between the phases are established upon natural gait events that are inevitable and perceived reliably by sensors attached to our exoskeleton. The presented strategy provides a systematic way of adjusting the quantity of assistance that corresponds to the wearer's preference and needs, and also provides explicit principles for the initiation and termination of assistance. When a step begins, the maximum torque and duration of assistance are decided, and the torque profile for the entire step is designed in advance. We conduct experiments in order to investigate the effect on metabolic cost when walking on a motorized treadmill.

Effects of assistance timing on metabolic cost, assistance power, and gait parameters for a hip-type exoskeleton.

There are many important factors in developing an exoskeleton for assisting human locomotion. For example, the weight should be sufficiently light, the assist torque should be high enough to assist joint motion, and the assistance timing should be just right. Understanding how these design parameters affect overall performance of a complex human-machine system is critical for the development of these types of systems. The present study introduces an assistance timing controller that regulates assistance timing such that peak joint velocity and peak assistance power are offset by a reference value for our hip-type exoskeleton. This is followed by measuring the manner in which various assistance timing references affect an important metric for performance, namely metabolic cost. The results indicate that net metabolic cost exhibits a concave up pattern with the most reduction of 21%, when compared to walking without the exoskeleton, at 0% assistance timing reference. The study also examines assistance timing's effect on gait parameters; increase in assistance timing reference increases step length, decreases cadence, and increases walk ratio (i.e. step length/cadence ratio) during treadmill walking.