Abstract
This article presents a novel electromyography (EMG)-driven exoneuromusculoskeleton that integrates the neuromuscular electrical stimulation (NMES), soft pneumatic muscle, and exoskeleton techniques, for self-help upper limb training after stroke. The developed system can assist the elbow, wrist, and fingers to perform sequential arm reaching and withdrawing tasks under voluntary effort control through EMG, with a lightweight, compact, and low-power requirement design. The pressure/torque transmission properties of the designed musculoskeletons were quantified, and the assistive capability of the developed system was evaluated on patients with chronic stroke (n = 10). The designed musculoskeletons exerted sufficient mechanical torque to support joint extension for stroke survivors. Compared with the limb performance when no assistance was provided, the limb performance (measured as the range of motion in joint extension) significantly improved when mechanical torque and NMES were provided (p < 0.05). A pilot trial was conducted on patients with chronic stroke (n = 15) to investigate the feasibility of using the developed system in self-help training and the rehabilitation effects of the system. All the participants completed the self-help device-assisted training with minimal professional assistance. After a 20-session training, significant improvements were noted in the voluntary motor function and release of muscle spasticity at the elbow, wrist, and fingers, as indicated by the clinical scores (p < 0.05). The EMG parameters (p < 0.05) indicated that the muscular coordination of the entire upper limb improved significantly after training. The results suggested that the developed system can effectively support self-help upper limb rehabilitation after stroke. ClinicalTrials.gov Register Number NCT03752775.
Introduction
Upper limb motor deficits are noted in >80% of stroke survivors,1,2 who require continuous long-term physical rehabilitation to reduce upper limb impairments.3,4 Restoration of poststroke limb function requires intensive repeated training of the paralyzed limb5,6 with maximized voluntary motor effort7,8 and minimized compensatory motions in close-to-normal muscular coordination.8,9 However, long-term poststroke rehabilitation is challenging because of the expanding stroke population and insufficiency of professional staff worldwide.10,11 Effective rehabilitation methods with potential for self-help training by stroke survivors are urgently required to improve the independency of stroke survivors and decrease the burden on the health care system. Suitable technologies for these methods are currently lacking.11,12
Various rehabilitation robots have been developed to assist the labor-intensive process of physical poststroke training, with main advantages of higher dosage and lower cost compared with traditional “one-to-one” manual physical therapy.13 However, these robots are large equipment powered by alternating current (AC) that require professional operation in a clinical environment with limited access to outpatients. Mobile exoskeletons are an emerging technology with wearable application. These exoskeletons are powered by portable batteries and have potential for user-independent self-help rehabilitation that can be accessed anytime, even in unconventional environments (e.g., at home).12,14,15 However, currently available upper limb exoskeletons, which are composed of rigid materials and actuated by electrical motors, are constrained by their heavy weight and low torque-to-weight ratio, which limit their user-independent applications. These exoskeletons require high-power consumption because their actuations must generate sufficient torque to support paralyzed limbs as well as the weight of the system worn on the body. Thus, most exoskeletons require AC supply,11,15,16 which triggers electrical safety concerns for user-independent usage.
Furthermore, the body/device integration is neither stable nor comfortable in current rigid exoskeletons, with misalignment or migration occurring during repeated practice mainly because of the non-negligible weights mounted onto the paretic limb.11,14 Misalignments with additional loads deteriorate abnormal muscular coordination in the paralyzed upper limb, which undermines the rehabilitative potential of the aforementioned systems.17,18 Therefore, most rigid exoskeletons for poststroke upper limb rehabilitation are still used under the close assistance of professionals in clinical environments, and their rehabilitation effects in user-independent operations are unclear.
With the introduction of soft materials in mechanical actuation, soft robotic equipment has been designed using easily deformable materials with light and flexible actuators that conform to human body contours19–22 so as to achieve superior body/device integration to that provided by rigid robotic equipment. Three main types of actuation systems, namely cable, hydraulic, and pneumatic systems, are used in current wearable soft robots.21 Cable systems used cables with desired tension attached to a target limb for flexion/extension.11,23 The cable-driven upper limb exoskeletons usually have a lightweight design with low inertia in the wearable part accommodating possible joint misalignment between the paretic limb and the exoskeleton.23 However, the cable is driven by electric motors with gears/pulleys, leading to an increment of complexity and overall weight of the whole assembly.23 Hydraulic systems are powered by hydraulic pressure, and able to produce greater torque compared with the actuators in cable and pneumatic systems.11,23,24 However, few hydraulic systems have been developed for upper limb, because they are relatively heavy and complex in the design, requiring additional space to accommodate the fluid and to prevent leakages under pressure.11,16,23
In contrast, pneumatic systems (pneumatic muscles) are the most commonly adopted actuation for the upper limb.21,23 Pneumatic exoskeletons have high torque-to-weight ratios because of the low weight of the wearable part actuated by air.21,25–29 However, pneumatic systems are usually bulky and slow in power transmission from pressure to torque during air inflation by compressors for needed air volume and pressure compared with electrical motor actuation in rigid exoskeleton to achieve equivalent mechanical outputs (e.g., joint torque).23,30 Large and high-power compressors connected to the pneumatic muscles constrain these devices for user-independent applications.21 Thus, a novel lightweight mechanical design is required to achieve optimized body/device integration with fast power transmission, high torque-to-weight ratios, and low-power consumption for user-independent self-help rehabilitation.
Neuromuscular electrical stimulation (NMES), proposed for upper limb rehabilitation,31,32 can activate the contraction of impaired muscles to generate limb movement31,32 and effectively enhance the muscle force and sensory feedback for motor relearning after stroke.33 However, controlling motion kinematics, such as the range of motion (ROM) and trajectory, by using NMES alone is difficult because of the limited stimulating precision in fine motor control.34 Recently, NMES has been combined with mechanical robots in poststroke training.35 The combined NMES-robot treatment is more effective than treatment involving the use of only NMES or only a robot in upper limb rehabilitation, particularly in improving muscular coordination by reducing muscular compensation.36 The integration of NMES into a robot can trigger the biological actuation of target muscles to reduce the demand of mechanical support from the robot part.11 However, little has been done on the integration of NMES with mobile exoskeletons or soft robots.
In this study, we designed a multi-integrated robotic system that combines the NMES, soft pneumatic muscle, and exoskeleton techniques, namely exoneuromusculoskeleton, for upper limb rehabilitation after stroke. Mechanical integration between rigid exoskeleton and pneumatic muscle (i.e., exomusculoskeleton) can enable high torque-to-weight ratios with a compact size and fast power transmission. By combining NMES with the exomusculoskeleton (i.e., exoneuromusculoskeleton), the mechanical scale and power requirement of the entire system can be reduced due to the evoked muscular effort. In addition, NMES and mechanical assistance enable the achievement of close-to-normal muscular coordination with minimized compensatory motions. To optimize therapeutic outcomes, electromyography (EMG) of the paralyzed limb has been used to indicate voluntary intentions37 to maximize voluntary motor effort during practice for better improvements in voluntary motor functions with longer sustainability compared with those with passive limb motions.38
In this study, we designed an EMG-driven exoneuromusculoskeleton to assist the upper limb physical practice at the elbow, wrist, and fingers. The assistive capability of the designed system was evaluated on patients with chronic stroke. The designed system’s feasibility of self-help operation and rehabilitation effects were also investigated through a pilot single-group trial.
Methods
The designed exoneuromusculoskeleton (Fig. 1) could be worn on the paretic upper limb of a stroke survivor. The designed system comprised two wearable parts: the elbow (158 g) and wrist/hand (50 g). Both parts were connected to a pump box (80 g) mounted on the upper limb. Moreover, a control box (358 g) that included system control circuits and a rechargeable 12-V battery could be carried on the waist. The developed system can assist a stroke survivor to perform sequential arm reaching and withdrawing tasks, namely (1) elbow extension, (2) wrist extension with the hand open, (3) wrist flexion with the hand closed, and (4) elbow flexion. Real-time control and wireless communication between the control box and a mobile application (app) were achieved on a smartphone through a microprocessor and Bluetooth module.


