Effect of pressure biofeedback training combined with Liuzijue Qigong training on respiratory function improvement in post-stroke patients with tracheotomy and decannulation: study protocol for a randomised controlled trial.

INTRODUCTION

Stroke causes neurological deficits and respiratory dysfunction, with prolonged bed rest exacerbating secondary pulmonary injury. This study evaluated the efficacy of pressure biofeedback training combined with Liuzijue Qigong (LQG) in improving functional outcomes and respiratory function in patients with tracheostomised stroke.

METHODS AND ANALYSIS

This will be a parallel, single-centre randomised controlled trial involving 66 patients. Eligible patients will be randomly allocated to receive pressure biofeedback therapy combined with LQG training or simple pressure biofeedback training only. The primary outcomes will be the Chelsea Critical Care Physical Assessment Tool score and the findings of diaphragm ultrasound imaging. The secondary outcomes will include the National Institutes of Health Stroke Scale score, pulmonary function test score, maximum phonation time, SpO and arterial blood gas results. Outcome analyses will be conducted on both intention-to-treat and per-protocol populations. A preliminary analysis will test whether pressure biofeedback therapy combined with LQG training leads to statistically better outcomes. This trial will provide evidence of the effectiveness of pressure biofeedback training combined with LQG training on respiratory function in patients with stroke after tracheal occlusion.

ETHICS AND DISSEMINATION

This study protocol was approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Centre (reference number: Yangzhi2024-137). All study participants will be required to provide written informed consent. The findings of this study will be submitted to a peer-reviewed journal for publication and presented at scientific conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2500097509.