Swallow Strength and Skill Training with biofeedback In acute Post stroke dysphagia (ssSIP): a protocol for a...

Area of Science:

• Neurology
• Rehabilitation Medicine
• Speech-Language Pathology

Background:

• Post-stroke dysphagia is a common complication impacting patient health and well-being.
• Behavioral interventions like swallow strength and skill training with biofeedback show promise for dysphagia management.
• The optimal dose and feasibility of early, intensive dysphagia therapy in acute inpatient settings remain unclear.

Purpose of the Study:

• To determine the feasibility of implementing swallow strength and skill training with biofeedback in acute inpatient stroke units.
• To explore the impact of different intervention doses (low vs. high intensity) on swallowing outcomes.
• To gather data for a potential definitive study on dysphagia therapy effectiveness.

Main Methods:

• A multi-center, prospective randomized controlled feasibility trial involving 120 participants.
• Participants randomized to usual care, low-intensity (once daily), or high-intensity (twice daily) therapy for 2 weeks.
• Intervention involved 35-minute sessions of swallow strength and skill training with surface electromyographic biofeedback.

Main Results:

• Primary outcomes focused on recruitment rates and treatment fidelity to assess feasibility.
• Secondary outcomes will examine treatment effects on swallowing, clinical status, quality of life, and health economics.
• A qualitative process evaluation will identify barriers and enablers to intervention delivery.

Conclusions:

• This feasibility trial will provide crucial data for designing a definitive study on the optimal dose of dysphagia therapy.
• Findings will inform the effectiveness of swallow strength and skill training with biofeedback for improving dysphagia severity post-stroke.
• The process evaluation will guide refinements for effective intervention delivery and trial procedures.