Blood flow restriction training combined with muscle energy technology for upper limb functional recovery in poststroke spasticity: a randomised controlled trial protocol at a tertiary hospital in Jiaxing, China.

INTRODUCTION

Stroke is a leading cause of death and disability worldwide, with spasticity affecting 4%-42.6% of stroke survivors. Prolonged spasticity can lead to pain, restricted joint mobility and muscle weakness. Current non-pharmacological treatments include physical therapy, orthoses and surgery. Muscle energy techniques (METs) and blood flow restriction training (BFRT) have shown promise in improving muscle function and reducing spasticity. This study aims to investigate the combined effect of MET and BFRT on upper limb motor function in patients with poststroke spasticity.

METHODS AND ANALYSIS

This study is a single-blind randomised controlled trial involving patients with poststroke spasticity. Participants will be randomly assigned to either the MET+BFRT group or the passive stretching group. Both groups will receive conventional rehabilitation therapy, with additional MET+BFRT or passive stretching interventions. The intervention will last for 6 weeks, with four sessions per week. Primary outcomes include the simplified Fugl-Meyer assessment (FMA) and surface electromyography, while secondary outcomes include the Modified Barthel Index and the Modified Ashworth Scale.Based on literature data, patients who had a stroke have an average baseline upper limb FMA score of 40 points. Conventional rehabilitation typically improves FMA to 46 points (SD=8). This trial expects an additional 6-point improvement from the intervention. With α=0.05 (two-sided), 90% power (1-β=0.90) and 10% dropout rate, PASS V.11.0 calculation indicates a minimum requirement of 42 participants per group.Statistical analysis will be conducted using IBM SPSS Statistics V.25. Intention-to-treat analysis will be used to analyse the result, which means the last observation will be used for interpolation when data are missing. Continuous variables will be summarised as mean±SD for normally distributed data or as median and IQRs for non-normally distributed data. Categorical variables will be presented as frequencies and percentages. For continuous variables that meet the criteria of normal distribution and homogeneity of variance, two-way analysis of variance with repeated measures will be applied; for those that do not meet these criteria, the Mann-Whitney U test will be used. Categorical variables will be analysed with the χ test or Fisher's exact test.

ETHICS AND DISSEMINATION

The study protocol has been approved by the ethics committee of Jiaxing Hospital of Traditional Chinese Medicine (2024-016). Participants will provide written informed consent before inclusion. The results will be disseminated through peer-reviewed journals and conference presentations.

TRIAL REGISTRATION NUMBER

ChiCTR2400085996.