The effect and biomechanical mechanisms of intradermal needle for post-stroke hemiplegia recovery Study protocol for a randomized controlled pilot trial

Abstract

The incidence of stroke has increased significantly in recent years. Post-stroke hemiplegia is a common stroke complication with long-term negative consequences. Several studies have suggested that acupuncture could be an effective intervention for the rehabilitation of post-stroke hemiplegia. Intradermal needling is a kind of acupuncture which is widely used in clinical settings. This study attempts to investigate the biomechanical effects of intradermal needle for post-stroke hemiplegia recovery. This proposed study is a single-centered, prospective, single-blinded (patient-assessor-blinded), randomized clinical pilot trial involving 40 patients with post-stroke hemiplegia. Patients will be randomized to an experimental group or control group in a 1:1 ratio. All of them will receive conventional rehabilitation therapies. Patients in the experimental group will be treated with intradermal needle, whereas patients in the control group will receive sham intradermal needle. The primary outcome measures will be biomechanically validated from the parameters of RSSCAN gait system: plantar pressure distribution, step length, and stride. The scores of clinical scales such as National Institutes of Health Stroke Scale, Fugl-Meyer Assessment, Berg Balance Scale, Barthel Index, and Stroke-specific Quality of Life Scale will be assessed as secondary outcome measures. All assessments will be conducted at baseline, 4 weeks after intervention and at the end of 3 months’ follow-up. The purpose of this study is to explore the potential effect and biomechanical mechanisms of intradermal needle for post-stroke hemiplegia recovery, as well as to provide a basis for future larger clinical studies.