Effect of a Soft Robotic Sock Device on Lower Extremity Rehabilitation following Stroke: A Preliminary Clinical Study with Focus on Deep Vein Thrombosis Prevention

Background and objective: Immobility of the lower extremity due to medical conditions such as stroke can lead to medical complications such as deep vein thrombosis or ankle contracture, and thereafter prolonged recovery process of the patients. In this preliminary clinical study, we aimed to examine the effect of a novel soft robotic sock device, capable of providing assisted ankle exercise, in improving blood flow in the lower limb to prevent complication of stroke such as deep vein thrombosis and joint contracture. Methods: Stroke patients were recruited (n=17) to compare patients using the conventional pneumatic compression device with our robotic sock device on separate days. The primary outcome was to compare the venous flow profile of the superficial femoral vein in terms of the time average mean velocity and volumetric flow. The secondary outcome was to identify the ankle joint range of motion with assistance of the device. Results: We noted improvements in the venous profile at the early phase of the device use, though its efficacy seemed to drop with time, as compared to the IPC device where there was significant improvement in the venous profile. The ankle joint dorsiflexion-plantarflexion range of motion assisted by the device was 11.5±6.3°. Conclusion and clinical impact: The current version of our sock device appears to be capable of improving venous blood flow in the early phase of device use and assisting with ankle joint exercise. The insights from this preliminary clinical study will serve as the basis for further improvement of the device and subsequent conduct of a longitudinal clinical trial. Funding: National Health Innovation Centre Singapore (NHIC) grant, R-172-000-391-511, MOE AcRF Tier 1 R-397-000-301-114 .