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.

Trial design: This study is a pilot randomized clinical trial 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.

Methods: 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 min of conventional physiotherapy including electrotherapy and conventional exercises, and then the intervention group did gait training for 30 min with the HEXA robot and the control group for 30 min 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.

Results: 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. 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.

Conclusion: It seems that the HEXA robot can effectively improve walking capacity and speed.