Effects of oral care combined with neuromuscular electrical stimulation on clinical outcomes in the acute phase of acute ischemic stroke: a pilot randomized controlled trial

BACKGROUND: Stroke-associated dysphagia significantly increases the risk of pneumonia in persons with acute ischemic stroke (AIS), yet effective early interventions remain limited. This pilot randomized controlled trial examined the feasibility and clinical effects of a nurse-delivered combined intervention involving neuromuscular electrical stimulation (NMES) and comprehensive oral care-including toothbrushing using the Bass method, tongue cleaning, and moisturizing twice daily-during the acute stroke phase. METHODS: This randomized, parallel group pilot trial assigned persons with AIS into three groups: (i) oral care only, (ii) oral care + NMES, and (iii) standard care (control). Interventions began within 48 h of stroke onset and continued twice daily for five days, starting within 48 h of stroke onset. Outcome measures, including the Revised Oral Assessment Guide (ROAG) and Gugging Swallowing Screening (GUSS), were assessed at baseline, day 4, and day 8 post-stroke. Statistical analysis employed one-way analysis of variance (ANOVA), chi-square tests, and generalized estimating equations (GEE) to analyze group differences and longitudinal trends. RESULTS: Among 35 participants (mean age 68.3 ± 12.5 years; 51.4% men), both intervention groups demonstrated significant improvements in swallowing and oral health outcomes over time, compared to standard care (p < 0.05). Although this pilot study was not powered to determine superiority between the two intervention groups, the oral care + NMES group demonstrated the greatest improvements in GUSS and ROAG scores. CONCLUSION: Findings from this pilot trial support the feasibility of nursing staff implementing combined oral care and NMES within 48 h of AIS onset. The results highlight the potential for meaningful clinical benefits, particularly in settings with limited access to specialized rehabilitation. Larger, blinded, multi-center trials are warranted to further evaluate the efficacy and broader applicability of this early intervention strategy. REGISTRATION: The study protocol was registered in the Protocol Registration and Results System (PRS) under ID N202108021 as a supplementary registration due to initial unfamiliarity with PRS registration requirements, with the registration date recorded as 11/14/2024.