Background: As the most common functional disability in stroke patients with hemiplegia, poststroke cavovarus foot (PCF) seriously affects the life quality of patients and causes mental and emotional disorders. Some studies have suggested that the traditional Chinese medicine fumigation therapy could be an effective intervention method for PCF patients. This study aims to investigate the biomechanical effect of the classic prescription Peony and licorice decoction (PLD) fumigation in the treatment of PCF.
Methods/Design: This study is a multi-center, randomized, placebo-controlled, double blind trial. A total of 190 patients with PCF according to the inclusion criteria will be recruited in three centers and randomized and distributed to either the intervention group or the control group at a 1:1 ratio. All patients will receive standardized modern rehabilitation treatment according to the “Chinese Guidelines for Stroke Rehabilitation” (2011 version). Patients will stick to the treatments they used to take, and will be given present general treatment when acute exacerbation of stroke occurs during the trial. The intervention group will receive PLD fumigation treatment, while the control group will receive placebo fumigation treatment. The primary outcome measure is medial plantar area (M1+M2+HM) generating from the RSSCAN gait system. The secondary outcome measures contain the scores of clinical scales including Berg Balance Scale, Fugl-Meyer Assessment, Modified Ashworth Scale, Barthel Index, and Stroke-Specific Quality of Life Scale. All assessments will be implemented at baseline, 4 weeks after intervention and at the end of 3 month’ follow-up. Intention-to-treat analysis and per-protocol analysis will be applied in this trial.
Discussion: The results of this study are expected to provide detailed interpretations of clinical effects and biomechanical mechanisms of PLD fumigation in the treatment of PCF. If PLD fumigation treatment is confirmed as an effective option, this study may additionally set up the new treatment method for patients with PCF and provide foundations for further clinical studies on a larger scale.
Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032433. Registered on 28 April 2020.