Pharmacist-led evaluation of a novel nail-cutting innovation versus conventional trimming in hemiplegic patients: A Randomized controlled trial

Abstract

Background: Hemiplegic patients often have trouble maintaining nail hygiene due to unilateral hand dysfunction, increasing the risk of perionychial injury, infection, and reduced quality of life. Assistive devices enabling safe, independent nail trimming may address these challenges while supporting preventive health strategies. Objective: To evaluate the efficacy and safety of a novel one-handed, electrically powered nail-cutting device compared with conventional manual clippers in hemiplegic patients. Methods: A randomized controlled trial was conducted at Naresuan University Hospital in two phases: preliminary testing in healthy volunteers (n=10) and clinical evaluation in hemiplegic patients (n=20). Participants were randomized to use either the novel device or conventional clippers. Primary outcomes were trimming quality (shape uniformity, smoothness of edges) and safety (incidence of perionychial injury, pain scores). Secondary outcomes included user satisfaction and completion time. Randomization, independent allocation, standardized training, and blinded outcome assessment were employed to enhance internal validity. Results: In hemiplegic patients, the novel device achieved smoother nail edges, preserved nail integrity, and significantly reduced pain compared with conventional clippers (mean difference in pain score: –0.68; 95% CI: –1.28 to –0.08). No perionychial injuries occurred in the intervention group. Satisfaction scores were consistently high, with participants reporting enhanced self-esteem and perceived safety. Similar performance and safety were observed in healthy volunteers. Conclusion: The novel one-handed electric nailcutting device demonstrated superior efficacy, safety, and user satisfaction compared with conventional clippers in hemiplegic patients. While findings are promising, larger multi-center trials with longer follow-up are warranted to confirm these results and assess cost-effectiveness and long-term adherence.