Effectiveness of transcutaneous spinal direct current stimulation combined with exercise training in patients with anterior cruciate ligament reconstruction: study protocol for a randomized controlled trial
摘要
Current standardized rehabilitation protocols for anterior cruciate ligament reconstruction (ACLR) often fail to fully resolve functional deficits arising from initial injury and subsequent surgery. These lingering issues are tied to neural impairments such as reduced corticospinal excitability and weakened motor cortex activation, which disrupt sensorimotor signal transmission, impair motor control, and hinder recovery even after post-operative rehabilitation. Growing evidence suggests that advancing post-ACLR care should synchronize the normalization of neural pathways with peripheral musculoskeletal recovery. Transcutaneous spinal direct current stimulation (tsDCS), an emerging non-invasive neuromodulatory technique, can modulate neural function and enhance motor performance. This study aims to investigate the safety and efficacy of interventions that combine simultaneous exercise with tsDCS in the rehabilitation of patients following ACLR.
MethodsThis study will be a double-blind, randomized controlled trial with a two-arm parallel-group design and a 1:1 allocation ratio. All participants get routine rehabilitation. Patients will remain supine during stimulation, with a total duration of 20 min and a constant current of 2.0 mA. The experimental group receives tsDCS plus exercise training, with cathode at T10 spinous process and anode at uninjured deltoid. During tsDCS, they perform straight leg raises with the reconstructed limb. The control group gets sham stimulation plus exercise training. The primary outcome is the Knee Injury and Osteoarthritis Outcome Score at 18 months post-surgery. This study explores the effect of tsDCS intervention on early corticospinal excitability in post-ACLR patients, with indicators measured via transcranial magnetic stimulation. The secondary outcomes include self-reported measures such as pain, sports psychology, motor function and quality of life, as well as objective assessments such as range of motion, muscle strength, muscle endurance, gait, balance, proprioception, stability and cerebral function changes.
DiscussionThis study addresses a critical gap in ACLR rehabilitation, as standardized protocols often overlook neural impairments linked to persistent functional deficits. The combined intervention of tsDCS and exercise training is expected to promote accelerated rehabilitation after ACLR. This study offers guidance for optimizing neuromodulatory strategies in orthopedic rehabilitation.
Trial registrationChiCTR ChiCTR2400079530. Registered on 05 January 2024. https://www.chictr.org.cn/showproj.html?proj=216406.