A Randomized Controlled Trial to Test the Effects of Repetitive Peripheral Magnetic Stimulation Versus Neuromuscular Electrical Stimulation in Patients with Spastic Hemiparesis After Stroke (REPMAST): Study Protocol.

BACKGROUND/OBJECTIVES: Innovative therapies are needed to reduce disability, facilitate activities of daily living, and improve the quality of life in patients with stroke. Non-invasive methods of stimulating the peripheral and central nervous system are increasingly being used to enhance the effects of existing therapies in stroke rehabilitation. One potentially relevant method for achieving greater improvement is repetitive peripheral magnetic stimulation (rPMS). This randomized controlled trial (RCT), the Peripheral MAgnetic stimulation in patients with spastic hemiparesis after Stroke Trial (REPMAST), will investigate whether rPMS improves upper extremity function, spasticity, and activities of daily living in patients with stroke compared with neuromuscular stimulation (NMS).

METHODS

REPMAST is an interventional, randomized controlled single-blinded study. Patients with subacute stroke are randomized to receive rPMS or NMS five days a week for three weeks in addition to standard rehabilitation therapy. The primary outcome is the change in the Fugl-Meyer Assessment for Upper Extremity between the beginning and end of the stimulation sessions. Secondary outcomes include changes in the Katz Index of Independence in Activities of Daily Living, the Timed Up and Go Test, the Modified Ashworth Scale, and the Tardieu Scale. A total sample size of 138 patients (69 in each group) is required to investigate the superiority of rPMS compared with NMS.

CONCLUSIONS

The aim of this RCT is to provide evidence for an effective peripheral stimulation treatment for stroke recovery.