Clinical Research Directory

Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial

Sponsor: María Belén Martínez Luna

Summary

Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown. This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.

Official title: Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot

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