A community-based, bionic leg rehabilitation program for patients with chronic stroke: clinical trial protocol

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-centre, 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 which 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 either: i) physiotherapy plus community-based bionic leg training program, ii) physiotherapy only, or iii) 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 assessment, identical to baseline, will occur after 10-weeks, 3 and 12 months post intervention. 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.