Radial Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Type A for Post-Stroke Lower Limb Spasticity (SOLUTION)
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.
Gender: All
Ages: 18 Years - Any
Stroke
Spasticity as Sequela of Stroke
Lower Limb Spasticity
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