The biomechanical effect of acupuncture for poststroke cavovarus foot: study protocol for a randomized controlled pilot trial

BACKGROUND: Poststroke cavovarus foot greatly affects patients’ activities of daily life and raises the risks of falls and consequent fractures. Acupuncture appears to be safe and effective in promoting motor functions and enhancing the activities of daily life among patients with poststroke cavovarus foot. The current study aims to study the biomechanical effect of acupuncture for poststroke cavovarus foot with objective outcome measurements. METHODS/DESIGN: This is an assessor and analyst-blinded, randomized, controlled pilot study. A total of 60 eligible patients with poststroke cavovarus foot will be allocated by a 1:1 ratio into an acupuncture treatment group and a control group. Patients in the control group will receive conventional rehabilitation therapies, whereas a combination of acupuncture and conventional rehabilitation therapies will be applied in the acupuncture group. The primary outcome measures are three objective biomechanical parameters from the RSSCAN gait system: varus angle, dynamic plantar pressure distribution, and static plantar contact area. Scores of the Berg Balance Scale, the Fugl-Meyer Assessment, and the Stroke-Specific Quality of Life Scale, as well as other biomechanical parameters such as the step length and width, step time phase, and weight shifting phase will be selected as secondary outcome measurements. All assessments will be conducted at baseline, 4 weeks after the treatment course, and after a follow-up period of 3 months. DISCUSSION: Results of the current study will provide detailed interpretations of the biomechanical effect of acupuncture for stroke rehabilitation and foundations for future larger clinical studies. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-IPC-15006889 (8 August 2015).