Effects of Extracorporeal Shockwave Therapy Combined with Neuroplasticity-Based Training Protocol on Lower Limb Spasticity in Stroke Patients: A Randomized Controlled Trial with Ultrasonography Evaluation

Background Post-stroke spasticity (PSS) arises from central neural hyperexcitability and maladaptive muscle architectural changes that impair motor function. Interventions targeting both mechanisms is essential to support adaptive neural reorganization. Objective To investigate the combined effects of extracorporeal shockwave therapy (ESWT) and a neuroplasticity-based training protocol (NBTP) on lower limb spasticity, muscle architecture, and motor function in stroke patients. Methods This was a sham-controlled, double-blind, randomized controlled trial. Fifty-four patients with post-stroke spasticity (PSS) were randomly assigned to receive either ESWT combined with a NBTP, or to sham ESWT with NBTP . Participants received six weekly sessions of ESWT (1,500 shocks at 5 Hz, 0.10 mJ/mm2) targeting the gastrocnemius muscle, alongside a 12-week NBTP comprising mirror therapy, resistance and aerobic training, motor imagery, and task-specific activities. Outcome assessments were conducted at baseline, 6th week, and 12th week using the Modified Ashworth Scale (MAS), passive range of motion (PROM), and the Fugl-Meyer Assessment–Lower Extremity (FMA-LE). Ultrasonographic evaluations included measurements of muscle thickness (MT), muscle fascicle length (MFL), and pennation angle (PA). Results At the 12th week, the experimental group showed significantly greater improvements than controls in MAS (MD = 0.88; p < 0.001), PROM (MD = −6.72; p < 0.001), and FMA-LE (MD = −1.55; p < 0.001). RMI also improved moderatly (MD = −1.04; p = 0.03). Ultrasonographic parameters improved in both groups, with a significant difference observed only in PA and MT (p < 0.05). Conclusion ESWT combined with NBTP yielded superior functional and structural outcomes compared with NBTP, supporting this integrative approach as a clinically relevant post-stroke intervention. Trial registration number Trial was submitted on http://clinicaltrials.gov (registration no. NCT05405140).