Single Versus Three Sessions of Focused Extracorporeal Shock Wave Therapy for Poststroke Spastic Equinus: A Randomized Clinical Trial

Background/Objectives: Lower limb spasticity is a common complication of stroke. Spastic equinovarus foot substantially affects mobility and quality of life. Focused extracorporeal shock wave therapy (fESWT) is a noninvasive treatment option, although the optimal number of sessions remains unclear. Objectives: We aimed to compare clinical and functional trajectories following two fESWT protocols in patients with poststroke spastic equinus over a 12-week follow-up period. Methods: This randomized, open-label, single-center trial included 40 patients randomly assigned to one fESWT session (group 1) or three sessions administered once weekly for three consecutive weeks (group 2). Outcomes included spasticity (Modified Ashworth Scale, MAS), passive range of motion (PROM), functional mobility and dynamic balance (Timed Up and Go test, TUG), and walking capacity (six-minute walk test, 6MWT). Assessments were performed at baseline and at 1, 4, 8, and 12 weeks. Statistical significance was set at α = 0.05. Results: Thirty-two patients completed the 12-week follow-up. No significant between-group differences were observed at any follow-up assessment. Both groups showed significant improvements in MAS scores and PROM relative to baseline during follow-up. A significant group × time interaction for PROM indicated different temporal response patterns between groups. No significant changes were observed in TUG performance. The 6MWT showed a significant main effect of time, with significant improvement in group 1 at 12 weeks. Conclusions: Both fESWT protocols were associated with reduced spasticity and improved range of motion over 12 weeks. Three sessions showed no detectable additional clinical benefit over a single session for spasticity or the functional outcomes assessed.