Background Dysphagia following oral cancer ablative surgery with free flap reconstruction significantly impairs quality of life, yet personalized rehabilitation approaches remain understudied. This randomized controlled trial compared a personalized swallowing rehabilitation program with standard care in these patients. Methods This single-center randomized controlled trial enrolled 300 patients with oral squamous cell carcinoma who underwent tumor resection with free flap reconstruction between January 2022 and December 2025 at Shanghai Fengcheng Hospital. Patients were randomly assigned (1:1) to receive either a personalized swallowing rehabilitation program (n=150) incorporating neuromuscular electrical stimulation, surface electromyography biofeedback, tongue pressure resistance training, and individualized exercise protocols, or standard care (n=150) consisting of conventional swallowing exercises. The primary outcome was the Functional Oral Intake Scale (FOIS) score at 6 months. Secondary outcomes included MD Anderson Dysphagia Inventory (MDADI) scores, aspiration rates, time to oral feeding recovery, feeding tube dependency, and aspiration pneumonia incidence, assessed at 1, 3, and 6 months postoperatively. Results At 6 months, the personalized rehabilitation group demonstrated significantly higher FOIS scores compared with standard care (median, 7 interquartile range (IQR), 6–7 vs 6 IQR, 5–6; Hodges-Lehmann median difference, 1.00; 95% CI, 1.00–1.00; P 0.001; effect size r = 0.366). The intervention group showed superior MDADI composite scores (median, 75.57 IQR, 65.99–86.06 vs 65.80 IQR, 56.30–74.40; P 0.001), lower aspiration rates (12.0% vs 21.3%; relative risk, 0.56; P = 0.044), shorter time to oral feeding recovery (median, 15.84 vs 19.80 days; P 0.001), and reduced feeding tube dependency at 6 months (8.7% vs 28.7%; P 0.001). Subgroup analyses demonstrated consistent benefits across tumor sites, clinical stages, and reconstruction types, though the effect was attenuated in patients receiving adjuvant chemoradiotherapy (P = 0.201). The mean adherence rate in the intervention group was 78.96% ± 13.34%. Conclusions A personalized swallowing rehabilitation program significantly improves functional swallowing outcomes, reduces aspiration risk, and enhances swallowing-related quality of life compared with standard care in oral cancer patients following surgical resection with free flap reconstruction. These findings support the integration of individualized, multimodal rehabilitation strategies into routine postoperative management.
Zhang et al. (2026) studied this question.