Background: Although early rehabilitation is important following a stroke, severely affected patients have limited options for intensive rehabilitation as they are often bedridden. To create a system for early rehabilitation of lower extremities in severely affected patients, we have combined the robotic manipulator ROBERT® and EMG-triggered FES and developed a novel user-driven Assist- As-Needed (AAN) control approach. The method is based on a state machine that can detect user movement capability and provide different levels of assistance, as required by the patient (no support, FES only, and simultaneous FES and mechanical support).

Methods: To technically validate the system, we tested 10 able-bodied participants who were instructed to perform specific behaviors to trigger the desired system states while conducting knee extension and ankle dorsal flexion exercise. In addition, the system was tested on two stroke patients to establish the clinical feasibility.

Results: The technical validation showed that the state machine correctly detected the participants’ behavior and activated the target AAN state in more than 96% of the exercise repetitions. The clinical feasibility test showed that the system successfully recognized the patients’ movement capacity and activated assistive states according to their needs, providing the minimal level of support required to perform the exercise successfully.

Conclusions: The system was technically validated and preliminarily proven clinically feasible. The present study shows that the novel system can be used to deliver exercises with a high number of repetitions while engaging the participants’ residual capabilities through an effective AAN strategy.