Swallow Strength and Skill Training with Biofeedback in Acute Post Stroke Dysphagia (ssSIP): Protocol paper.

Abstract Background Post stroke dysphagia is common and has negative consequences on health and wellbeing. Collectively behavioural interventions including swallow strength and skill training with biofeedback improve dysphagia, but little is known about which interventions are most effective and at what dose. Early intensive intervention may be most beneficial for motor recovery, but it is unclear whether dysphagia therapy such as this is feasible to deliver in the inpatient acute stage. Aim To understand the feasibility of clinical teams delivering swallow strength and skill training with biofeedback in acute inpatient stroke and explore which dose may result in better outcomes. Methods 120 participants from inpatient stroke units in the UK will be recruited in this multicentre prospective randomised controlled feasibility trial. If eligible they will be randomised to either usual care, low intensity therapy or high intensity therapy groups. In addition to usual care, treatment groups will receive 10–20 x 35-minute sessions of swallow strength and skill training with surface electromyographic biofeedback over two weeks. The primary outcome is feasibility measured by recruitment and treatment fidelity. Secondary outcomes will explore treatment effects and dose of the intervention on swallowing, clinical, quality of life and health economic outcomes. Embedded qualitative process evaluation of intervention delivery (fidelity, barriers and enablers), clinical staff training and trial procedures informed by the Conceptual Framework for Intervention Fidelity (CFIF) and Conceptual Framework for Implementation Research (CFIR). Criteria have been outlined for progression to a definitive study. Discussion This trial will inform the feasibility of a definitive study to determine the effectiveness of optimal of dose swallow strength and skill training with surface electromyographic biofeedback on severity of dysphagia three months post stroke. The process evaluation will inform refinements to intervention, training and trial procedures to ensure effective delivery. Trial registration Registration Clinical Trials.gov NCT05744245, Date of release 20/12/2022