The effect of baduanjin exercise in rehabilitation for functional ankle instability: A study protocol for a randomized controlled pilot trial

Introduction: Patients with functional ankle instability (FAI) have problems with joint control, balance, gait, and postural symmetry. Baduanjin is a type of traditional Chinese exercise that has been shown to be effective in treating many diseases and symptoms. However, to date, the effect of Baduanjin in patients with FAI has not been proved. This pilot trial is an assessor-blinded randomized controlled trial, and its objective is to study the efficacy and safety of Baduanjin on the rehabilitation of patients with FAI. Methods: Seventy-two participants, who are eligible according to specified inclusion and exclusion criteria, will be randomized (in a 1:1 ratio), using a random number table, into two groups: a Baduanjin group and a conventional treatment group. The Baduanjin group will be subjected to the Baduanjin exercise in addition to the conventional treatment therapy. Participants' exercise programs will be implemented for 4 weeks (5 days a week). All participants will be assessed at baseline, and after two and 4 weeks of treatment. The surface electromyography results of the bilateral erector spinae, tibialis anterior, and peroneus longus will be the primary outcomes, while the balance function under different conditions and the level of FAI in daily life measured using the Cumberland Ankle Instability Tool will be the secondary outcomes. Ethics and Dissemination: The trial has been approved by the Research Ethical Committee of Dongzhimen Hospital, the First Affiliated Hospital of Beijing University of Chinese Medicine (no. DZMEC-KY-2019-18), and it will follow the principles of the Consolidated Standards of Reporting Trials statements as well as the Declaration of Helsinki. The findings of this study will be submitted for publication in peer-reviewed journals. The results will also be disseminated to the participants via phone calls or e-mail. Trial registration: Chinese Clinical Trial Register ID: ChiCTR1900021939 (March 17, 2019). http://www.chictr.org.cn/.