Abstract
Background: Upper limb exoskeletons have drawn significant attention in neurorehabilitation because of anthropomorphic mechanical structure analogous to human anatomy. Whereas, the training movements are typically underorganized because most exoskeletons only control the movement of the hand in space, without considering rehabilitation of joint motion, particularly inter-joint postural synergy. The purposes of this study were to explore the application of a postural synergy-based exoskeleton (Armule) reproducing natural human movements for robot-assisted neurorehabilitation and to preliminarily assess its effect on patients' upper limb motor control after stroke. Methods: We developed a novel upper limb exoskeleton based on the concept of postural synergy, which provided five degrees of freedom (DOF) , natural human movements of the upper limb. Eight participants with hemiplegia due to a first-ever, unilateral stroke were recruited and included. They participated in exoskeleton therapy sessions 45 minutes/day, 5 days/week for 4 weeks, with passive/active training under anthropomorphic trajectories and postures. The primary outcome was the Fugl-Meyer Assessment for Upper Extremities (FMA-UE). The secondary outcomes were the Action Research Arm Test(ARAT), modified Barthel Index (mBI) , and exoskeleton kinematic as well as interaction force metrics: motion smoothness in the joint space, postural synergy error, interaction force smoothness, and the intent response rate. Results: After the 4-weeks intervention, all subjects showed significant improvements in the following clinical measures: the FMA-UE ( p =0.02), the ARAT ( p =0.003), and the mBI score ( p <0.001). Besides, all subjects showed significant improvements in motion smoothness ( p =0.004), postural synergy error ( p =0.014), interaction force smoothness ( p =0.004), and the intent response rate ( p =0.008). Conclusions: The subjects were well adapted to our device that assisted in completing functional movements with natural human movement characteristics. The results of the preliminary clinical intervention indicate that the Armule exoskeleton improves individuals’ motor control and activities of daily living (ADL) function after stroke, which might be associated with kinematic and interaction force optimization and postural synergy modification during functional tasks. Clinical trial registration: ChiCTR, ChiCTR1900026656; Date of registration: October 17, 2019. http://www.chictr.org.cn/showproj.aspx?proj=44420