An interventional study of repetitive transcranial magnetic stimulation, rTMS and ankle stability training in Chronic Ankle Instability, CAI and Functional Magnetic Resonance Imaging (fMRI), sponsored by Wuhan University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Wuhan University · Not applicable, Interventional, and Treatment
Chronic ankle instability (CAI) is a common sports injury that often leads to recurrent injuries and functional deficits. While conventional rehabilitation can restore ankle stability, the underlying neurophysiological mechanisms remain poorly understood, and the long-term efficacy of current treatments is limited. This study aims to investigate the therapeutic efficacy of repetitive transcranial magnetic stimulation (rTMS) in combination with conventional ankle stability training for CAI and to evaluate its impact on ankle-stabilizing muscle activation and cerebral cortex excitability.
The study design is a single-center, randomized, single-blind, parallel-controlled trial. Participants with CAI will be randomly assigned to either an ankle stability training plus real rTMS group or an ankle stability training plus sham rTMS group. The primary outcome measure is the Cumberland Ankle Instability Tool (CAIT) score, which assesses the severity of ankle instability. Secondary outcomes include the Karlsson-Peterson Ankle Function Score (KPAFS), American Orthopedic Foot and Ankle Society Score (AOFAS), surface electromyography (sEMG) data, and task-based functional magnetic resonance imaging (fMRI) data. These secondary outcomes will provide a comprehensive evaluation of ankle function, muscle activation patterns, and neural activity changes.
The intervention will consist of a 4-week program, with participants receiving rTMS sessions three times per week. Each rTMS session will target key brain regions. The ankle stability training will include exercises designed to improve strength, balance, and proprioception. The sham rTMS group will receive identical ankle stability training but with a placebo rTMS protocol to ensure blinding.
Data will be collected at baseline, 2 weeks, and 4 weeks. The primary outcome, CAIT score, will be used to assess the overall improvement in ankle stability. The KPAFS and AOFAS scores will provide additional measures of ankle function and pain. sEMG data will be collected during specific functional tasks to evaluate the activation patterns of the tibialis anterior, peroneus longus, and other relevant muscles. Task-based fMRI will be used to assess changes in brain activity in motor and sensory areas before and after the intervention.
Statistical analyses will be performed using SPSS 22.0. Data will be presented as mean ± standard deviation. Between-group differences will be compared using independent samples t-tests, and overall differences across time points will be assessed via two-way repeated-measures ANOVA or mixed-effects models. Post-hoc analyses will be conducted to identify specific time points and conditions where significant differences occur.
The study timeline spans from March 2025 to December 2026, including participant recruitment, intervention implementation, data collection, and analysis, as well as manuscript drafting. This research aims to provide new insights into the neurophysiological mechanisms of CAI and to offer a novel, evidence-based approach to the rehabilitation of CAI, potentially improving long-term outcomes and reducing the risk of recurrent injuries.
Wuhan University is the lead sponsor of 45 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Behavioral: ankle stability training · Device: Sham repetitive transcranial magnetic stimulation, SrTMS
Device: repetitive transcranial magnetic stimulation, rTMS · Behavioral: ankle stability training
Participants underwent rTMS intervention prior to daily ankle stability training. The interventional targets were the key cortical brain regions identified in preliminary studies, with stimulation applied to the contralateral cortical areas corresponding to the affected ankle joint. Parameters included a figure-of-8 coil, 10 Hz frequency, 2-second stimulation duration, 8-second inter-train intervals, 60 repetitions, totaling 1,200 pulses per session, with each session lasting 10 minutes. Ankle stability training commenced within 10 minutes post-rTMS, following the same duration and intensity as the Ankle Stability Training Group + Sham rTMS Group. The treatment was conducted three times per week for a total of 4 weeks.
The ankle stability training protocol comprised three modalities: neuromuscular training, balance training, and proprioceptive training. Specific exercises included single-leg stance, balance pad training, heel raises, resistive ankle inversion/eversion exercises, MOBO board balance exercises, alphabet tracing (toe-writing), lateral walking, heel walking, toe walking, and jump and landing control drills. The training progressed from stable to unstable surfaces, starting at low intensity and gradually increasing in difficulty and intensity. The training was conducted three times per week for a total of 4 weeks.
Before each session of ankle stability training, participants received sham rTMS intervention. The sham stimulation mimicked the sensory experience of real rTMS but did not produce any physiological effects.
Cumberland Ankle Instability Tool score, CAIT
A self-reported questionnaire designed to assess functional ankle instability. It consists of 9 items with a total score ranging from 0 to 30, where higher scores indicate better ankle stability.
Time frame: Before treatment, 2 week after treatment and 4 weeks after treatment
Karlsson-Peterson Ankle Function Score, KPAFS
The KPAFS is a scoring system used to evaluate ankle dysfunction. It includes 10 items: pain, daily activities, walking ability, need for support, squatting ability, ankle range of motion, limb positioning, limb length, limb circumference, and limb appearance. Each item is scored based on the patient's condition, with a total possible score of 100. Higher scores indicate better ankle function.
Time frame: Before treatment, 2 week after treatment and 4 weeks after treatment
American Orthopedic Foot and Ankle Society score, AOFAS
The AOFAS is a widely used assessment tool for evaluating functional outcomes in foot and ankle disorders. It includes domains such as pain, function, gait, range of motion, stability, and foot alignment. The total score ranges from 0 to 100, with higher scores reflecting better foot and ankle function.
Time frame: Before treatment, 2 week after treatment and 4 weeks after treatment
Surface electromyography
The surface electromyography of the tibialis anterior, gastrocnemius, and peroneus longus muscles was tested while the subjects were standing on one leg and undergoing the star excursion balance test (SEBT). The following indicators were collected: 1. Time-domain analysis indicators: Root Mean Square (RMS), Integrated Electromyography (iEMG), and Averaged Electromyography (AEM). 2. Frequency-domain analysis indicators: Mean Power Frequency (MPF) and Median Frequency (MF).
Time frame: Before treatment and 4 weeks after treatment
fMRI
Task - related fMRI data were collected by using the affected lower limb isometric contraction combined with "single - leg standing" motor imagery.
Time frame: Before treatment and 4 weeks after treatment
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Wuhan University