Interactive Acupuncture for Poststroke Dysphagia: Protocol for a Randomized Controlled Trial

Poststroke dysphagia (difficulty swallowing) is a common disabling complication of stroke and is associated with malnutrition, aspiration pneumonia, impaired quality of life, and mortality. Conventional swallowing rehabilitation and instrumental assessment are useful but may be limited by equipment dependence and inconsistent accessibility. Interactive acupuncture is a dynamic acupuncture procedure in which short needling stimulation at selected nape acupoints is synchronized with active swallowing tasks.

This protocol describes a multicenter, parallel-group randomized controlled trial that will evaluate whether interactive acupuncture improves swallowing function in patients with poststroke dysphagia compared with conventional acupuncture at the same acupoints.

A total of 100 participants with poststroke dysphagia will be randomized 1:1 to an interactive acupuncture group or a conventional acupuncture control group. Both groups will receive routine conventional medical care and standardized acupuncture therapy for stroke. The intervention course comprises 14 sessions delivered 6 times per week followed by a 1-month follow-up. The registered primary outcome is the water swallowing test (WST) grade; the primary efficacy comparison is the change in WST grade from baseline to immediately after the 14th treatment session. Secondary outcomes include the Standardized Swallowing Assessment, Functional Oral Intake Scale, Swallowing Quality of Life Questionnaire, instrumental and physiological assessments, inflammatory markers, safety outcomes, and a supportive WST responder analysis. Outcomes will be assessed at baseline; after sessions 3, 7, and 14; and at 1 month after treatment completion, where applicable.

The current amended protocol was approved by the Medical Ethics Committee of Hengshui Hospital of Traditional Chinese Medicine on August 25, 2026 (approval 2026-KY-09), and separate institutional ethics approval was obtained from the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine (approval Y2025-053-01). The study was funded in June 2025. The trial was registered with the International Traditional Medicine Clinical Trial Registry on December 30, 2025. Recruitment began on January 1, 2026; as of July 6, 2026, a total of 36 participants had been enrolled. Primary outcome data analysis has not yet begun. Recruitment is expected to continue until June 1, 2027, with final follow-up anticipated by July 2027 and submission of the primary results planned for September 2027.

This trial will clarify whether adding a task-synchronized interactive acupuncture procedure to the same acupoint prescription provides incremental benefit over conventional acupuncture for poststroke dysphagia and will provide a manualized, fidelity-monitored protocol for future clinical implementation.