The effect of using the Hip Exoskeleton Assistive (HEXA) robot compared to conventional physiotherapy on clinical functional outcomes in stroke patients with hemiplegia: A pilot randomized controlled trial

Abstract Recovery of gait function is very crucial in stroke rehabilitation and robotic-assisted gait training (RAGT) as a new approach is a good suggestion because conventional gait rehabilitation is expensive in various aspects and imposes a lot of burden on the physiotherapist. This study aimed to investigate the effect of using Hip Exoskeleton Assistive (HEXA) robot compared to conventional physiotherapy on the quality of walking, disability, and quality of life of stroke patients with hemiplegia. In this study, 24 patients were randomly assigned to the intervention group (robotic physiotherapy with HEXA robot), or control group (conventional physiotherapy). In each session, both groups received 30 minutes of conventional physiotherapy including electrotherapy and conventional exercises, and then the intervention group did gait training for 30 minutes with the HEXA robot and the control group for 30 minutes without the HEXA robot. The treatment program was 12 sessions, 3 times a week. Before the 1st and after the 12th sessions, both groups were evaluated for walking quality, disability, and quality of life. The results showed that the main effect of time was significant (P<0.05) in all outcomes and patients in both groups achieved significant improvement in all outcomes after the intervention. The main effect of the group was also significant in the outcomes of 6MWT (P<0.05) and TUG (P<0.05), and the intervention group patients experienced more distance and speed in these two tests. It seems that the HEXA robot can effectively improve walking capacity and speed. This study was approved by the ethics committee of Mashhad University of Medical Sciences (IR.MUMS.FHMPM.REC.1400.079 dated 28th Jan 2022). The trial was registered with the clinical trials site of www.IRCT.ir (IRCT20210730052024N1) on January 28th 2022.