Effects of programmed flexor–extensor alternating electrical acupoint stimulation on upper limb motor functional reconstruction after stroke: study protocol for a double-blind, randomized controlled trial

BACKGROUND: Stroke’s prevalence and morbidity are increasing (Guano, et al. Neuro 89:53–61, 2017), and limb motor dysfunction is left in most patients (Gittler, et al. JAMA 319:820–821, 2018). Particularly, the rehabilitation of upper limbs is more difficult and time-consuming (Borges, et al. The Cochrane database of systematic reviews 10:CD011887, 2018). METHODS: A double-blind randomized controlled trial (RCT) will be conducted to investigate whether a new functional electrical stimulation (FES) combined with acupoint therapy is more effective in the rehabilitation of upper limb motor dysfunction after stroke. Patients who meet the inclusion criteria will be randomly divided into two groups: programmed flexor–extensor alternating electrical acupoint stimulation group (PES group) and conventional flexor–extensor alternating electrical acupoint stimulation group (CES group), which will be treated for 3 weeks. The primary outcome measures are electroencephalogram (EEG) and surface electromyogram (sEMG). The secondary outcome variables include MBI (modified Barthel index), China Stroke Scale (CSS), FMA-U (Fugl-Meyer assessment upper limb), MMT (manual muscle testing), and Brunnstrom. DISCUSSION: The results of this study are expected to verify the efficacy of PES therapy in the rehabilitation of upper limb motor function after stroke. This may promote the widespread use of the therapy in hospitals, communities, and homes for early and continuous treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT05333497. Registered on April 11, 2022.