A Community-Based, Bionic Leg Rehabilitation Program for Patients with Chronic Stroke: Clinical Trial Protocol

Abstract

Stroke is a major global health problem whereby many survivors have unmet needs concerning mobility during recovery. As such, the use of robotic-assisted devices (i.e., a bionic leg) within a community setting may be an important adjunct to normal physiotherapy in chronic stroke survivors. This study will be a dual-center, randomized, parallel group clinical trial to investigate the impact of a community-based training program using a bionic leg on biomechanical, cardiovascular, and functional outcomes in stroke survivors. Following a baseline assessment that will assess gait, postural sway, vascular health (blood pressure, arterial stiffness), and functional outcomes (6-minute walk), participants will be randomized to a 10-week program group, incorporating (1) a physiotherapy plus community-based bionic leg training program; (2) physiotherapy only; or (3) usual care control. The training program will involve participants engaging in a minimum of 1 hour per day of bionic leg activities at home. Follow-up assessments, identical to baseline, will occur after 10 weeks, and 3 and 12 months postintervention. Given the practical implications of the study, the clinical significance of using the bionic leg will be assessed for each outcome variable. The potential improvements in gait, balance, vascular health, and functional status may have a meaningful impact on patients' quality of life. The integration of robotic devices within home-based rehabilitation programs may prove to be a cost-effective, practical, and beneficial resource for stroke survivors.

Keywords: Robotic assisted; blood pressure; gait; stroke survivors; walking.