Effects of transcranial magnetic stimulation on cortical network modulation and functional recovery in patients with chronic ankle injury following surgery: study protocol for randomised controlled trial

Introduction Single-modality motor rehabilitation is often insufficient to address the complex functional restoration needs of patients with chronic ankle injuries following surgery. Research indicates that non-invasive neuromodulation techniques, such as intermittent theta-burst stimulation (iTBS), may enhance motor recovery by increasing cortical excitability and facilitating neural network reorganisation. Compared with exercise therapy alone, this study aims to explore the rehabilitation efficacy of combining iTBS with exercise therapy in patients with chronic ankle injuries following surgery. It also investigates the associated cortical network modulation, providing scientific evidence to optimise rehabilitation strategies for these patients. Methods and analysis This study is a prospective, multicentre, randomised controlled trial with single-blind assessment. A total of 28 patients with chronic ankle injuries following surgery were enrolled and randomly assigned to either the experimental group or the control group according to centre-stratified randomisation. The experimental group will receive iTBS combined with exercise therapy, while the control group will receive sham iTBS combined with exercise therapy. Both groups will undergo one session per day, 5 days per week, for a total of 3 weeks. The primary outcome measure will be the American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Score (AOFAS). Secondary outcome measures will include isokinetic muscle strength assessment of the ankle dorsiflexor and plantarflexor muscles, Visual Analogue Scale (VAS) scores, ankle joint range of motion (ROM) and the 10-Metre Walk Test. Functional near-infrared spectroscopy (fNIRS) and transcranial magnetic stimulation (TMS) will also be used to assess cortical functional activity and neurophysiological changes. All outcome measures will be collected at baseline prior to enrolment, post-intervention at week 3, and at follow-up at week 6. Primary outcomes analyses will use group-by-time comparisons to examine between-group differences in functional and neurophysiological measures. Ethics and dissemination The study has received approval from the Medical Ethics Committee of Jiangsu Province (Suqian) Hospital (Application No. 2025-SR-0333). All participants will provide written informed consent before enrolment. Results will be disseminated through peer-reviewed journals and scientific conferences. Trial registration number ChiCTR2500110905. Protocol version V1.0.