Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for randomised controlled trial

Abstract Background Customized multi-muscle Functional Electrical Stimulation (FES) based on muscle synergy of the healthy adults, may provide opportunity for improve the upper limb motor function of the stroke survivors. Additionally, synergy-based FES combined with Robotic-assisted Therapy (RAT) can be a novel and more effective therapy for improving upper limb function of the stroke survivors from the perspective of synergistic enhancement. However, few studies examined the effectiveness of combined synergy-based FES and RAT for stroke upper limb function improvement, especially for the motor control evaluated by the Reach-To-Grasp (RTG) behavior. Methods This study will be an assessor-blind randomized controlled trial involving 12-week intervention and 6-month follow-up. The stratified randomization will be used to randomly assign the 120 stroke patients into FES + conventional rehabilitation programs (CRP) group, RAT + CRP group and FES-RAT + CRP group equally. Intervention will be 3 sessions a week, with a total of 36 sessions. The primary outcome measurements will include Fugl-Meyer Assessment and Biomechanical Assessment of RTG behavior. The secondary outcome measurements will include Quality of life and Brain Neuroplasticity assessment by MRI. There are five time points for the evaluation, including baseline, 6 weeks and 12 weeks from the start of treatment, and 3 months, 6 months following the end of treatment. Two-way of variance with repeated measures will be applied to examine the main effects of the group, the time factor and group-time interaction effects. Discussion The results of the study protocol will provide evidence with high quality for integrated synergy-based FES and RAT, and synergy-based FES alone, and guide significance for design more effective treatment methods in stroke rehabilitation. Trial registration number ChiCTR2300071588.