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Radial Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Type A for Post-Stroke Lower Limb Spasticity (SOLUTION)
Sponsor: Parc de Salut Mar
Summary
The goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment. The main questions it aims to answer are: * Does the addition of active rESWT to BoNT-A result in a greater improvement in lower-limb spasticity, measured by the change in Modified Ashworth Scale score from baseline to 5 weeks after treatment? * Does adjunctive rESWT improve other measures of muscle spasticity, ankle mobility, gait performance, perceived global improvement, and pain, and is the treatment safe and well tolerated? Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit. Participants will: * Receive ultrasound-guided BoNT-A injections according to the study protocol. * Receive either active rESWT or sham rESWT according to their randomly assigned treatment group. * Attend scheduled follow-up visits for assessment of spasticity, ankle range of motion, gait performance, muscle length, global clinical improvement, pain, and treatment safety. * Complete the planned assessments during the follow-up period, including evaluation at 5 weeks after treatment and subsequent follow-up assessments for up to 6 months.
Official title: SOLUTION: A Pilot Randomised, Double-Blind, Sham-Controlled Clinical Trial Evaluating the Efficacy and Safety of Radial Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Type A in Adults With Post-Stroke Lower Limb Spasticity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-02-01
Completion Date
2025-01-01
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar).
Ultrasound-guided abobotulinumtoxinA followed 24 hours later by three weekly sessions of radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar) vs Identical BoNT-A protocol followed by sham radial ESWT using identical procedures without therapeutic energy.
ARM B: Sham-radial shock Wave therapy
Sham-radial shock Wave therapy
Ultrasound-guided abobotulinumtoxin A
Ultrasound-guided abobotulinumtoxin A for ARM A and ARM B
Locations (1)
Rehabilitation Research Group, IMIM
Barcelona, Barcelona, Spain