Investigation of the Effectiveness of the Robotic ReStore Soft Exoskeleton in the Development of Early Mobilization, Walking, and Coordination of Stroke Patients: A Randomized Clinical Trial

Abstract

Medical robotics nowadays can prevent, treat, or alleviate numerous severe conditions, including the dire consequences of stroke. Our objective was to determine the effect of employing a robotic soft exoskeleton in therapy on the development of the early mobilization, gait, and coordination in stroke patients. The ReStore™ Soft Exo-Suit, a wearable exosuit developed by a leading company with exoskeleton technology, was utilized. It is a powered, lightweight device intended for use in stroke rehabilitation for people with lower limb disability. We performed a randomized clinical intervention, using a before–after trial design in a university hospital setting. A total of 48 patients with a history of stroke were included, of whom 39 were randomized and 30 completed the study. Interventions: Barthel Index and modified Rankin scale (mRS) patients were randomly assigned to a non-physical intervention control (n = 9 of 39 completed, 30 withdrew before baseline testing), or to a high-intensity agility program (15 sessions, 5 weeks, n = 30 completed). The main focus of assessment was on the Modified Rankin Scale. Additionally, we evaluated secondary factors including daily life functionality, five dimensions of health-related quality of life, the Beck depression inventory, the 6 min walk test (6MWT), the Berg Balance Scale (BBS), and static balance (center of pressure). The Robot-Assisted Gait Therapy (ROB/RAGT) program led to significant improvements across various measures, including a 37% improvement in Barthel Index scores, a 56% increase in 10 m walking speed, and a 68% improvement in 6 min walking distance, as well as notable enhancements in balance and stability. Additionally, the intervention group demonstrated significant gains in all these aspects compared to the control group. In conclusion, the use of robotic therapy can be beneficial in stroke rehabilitation. These devices support the restoration and improvement of movement in various ways and contribute to restoring balance and stability.