Robotic-assisted gait training combined with transcranial direct current stimulation in chronic stroke patients: A pilot double-blind, randomized controlled trial.

Abstract

Although robotic-assisted gait training (RAGT) is becoming a standard method in stroke rehabilitation, its effect on chronic stroke patients is uncertain. This study aimed to investigate whether anodal transcranial direct current stimulation (tDCS) enhances the effect of RAGT on functional ambulation in chronic stroke patients. Chronic hemiplegic stroke patients with a Functional Ambulatory Category (FAC) score≤4 were randomly assigned to either the RAGT with anodal tDCS (Anodal) group the sham tDCS (Sham) group. The patients were provided with RAGT for 45 min after allocated tDCS on the leg motor cortex in the impaired hemisphere for 20 min every weekday for 2 weeks. The primary outcome measure was the FAC, and the secondary outcome measures included 10-m walking test, 6-min walking test, Berg Balance Scale, Fugl-Meyer assessment of the lower extremity, Medical Research Council Scale, and motor-evoked potential (MEP) parameters. They were evaluated before treatment (T0), immediately after treatment (T1), and 4 weeks after the end of treatment (T2). Twenty-one patients were finally included. The percentage of participants who achieved improvement in the FAC score was greater in the Anodal group than in the Sham group, and the difference was significant at T2 (66.7% vs. 12.5%, p = 0.024). In secondary outcome measures, the Anodal group showed greater improvement in the 6-min walking test than the Sham group at T2 (56.49±38.87 vs. 23.59±17.00, p = 0.038). The changes in the MEP parameters were not significantly different between the two groups. This pilot study suggested that anodal tDCS on the leg motor cortex in the impaired hemisphere may facilitate the effect of RAGT on functional ambulation in chronic stroke patients. Larger clinical trials will be needed to confirm the effect of RAGT combined with tDCS in chronic stroke patients based on the present study.